    [Senate Hearing 115-538]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 115-538

         RESEARCH, DIAGNOSIS, AND TREATMENT FOR TRAUMATIC BRAIN INJURY/
                          CONCUSSION IN SERVICEMEMBERS

    =======================================================================

                                    HEARING

                                   BEFORE THE

                           SUBCOMMITTEE ON PERSONNEL

                                     OF THE

                          COMMITTEE ON ARMED SERVICES
                              UNITED STATES SENATE

                         ONE HUNDRED FIFTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                               DECEMBER 13, 2017

                                   __________

             Printed for the use of the Committee on Armed Services

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                          COMMITTEE ON ARMED SERVICES

     COMMITTEE ON ARMED SERVICES

      JOHN McCAIN, Arizona, Chairman	JACK REED, Rhode Island
    JAMES M. INHOFE, Oklahoma		BILL NELSON, Florida
    ROGER F. WICKER, Mississippi		CLAIRE McCASKILL, Missouri
    DEB FISCHER, Nebraska			JEANNE SHAHEEN, New Hampshire
    TOM COTTON, Arkansas			KIRSTEN E. GILLIBRAND, New York
    MIKE ROUNDS, South Dakota		RICHARD BLUMENTHAL, Connecticut
    JONI ERNST, Iowa			JOE DONNELLY, Indiana
    THOM TILLIS, North Carolina		MAZIE K. HIRONO, Hawaii
    DAN SULLIVAN, Alaska			TIM KAINE, Virginia
    DAVID PERDUE, Georgia			ANGUS S. KING, JR., Maine
    TED CRUZ, Texas				MARTIN HEINRICH, New Mexico
    LINDSEY GRAHAM, South Carolina		ELIZABETH WARREN, Massachusetts
    BEN SASSE, Nebraska			GARY C. PETERS, Michigan
    LUTHER STRANGE, Alabama

                 Christian D. Brose, Staff Director
                 Elizabeth L. King, Minority Staff Director

                                      (ii)

     ________________________________________________________________

                           Subcommittee on Personnel

       THOM TILLIS, North Carolina,
                 Chairman
    JONI ERNST, Iowa		KIRSTEN E. GILLIBRAND, New York
    LINDSEY GRAHAM, South Carolina	CLAIRE McCASKILL, Missouri
    BEN SASSE, Nebraska             ELIZABETH WARREN, Massachusetts

                           C O N T E N T S

    _________________________________________________________________

                          Wednesday, December 13, 2017

                                                                       Page

    Research, Diagnosis, and Treatment for Traumatic Brain Injury/        1
      Concussion in Servicemembers.

    Dodick, David W., M.D., Sports Neurology and Concussion Program       3
      Director, Mayo Clinic.
    Devick, Steven D., M.D., Chief Executive Officer King-Devick         13
      Technologies, Inc..
    Miles, Christopher M., M.D., Associate Director, Sports Medicine     17
      Fellowship, Wake Forest University.
    Colston, Captain Michael J., M.D., U.S. Navy, Director, Military     28
      Health Policy and Oversight for the Assistant Secretary of
      Defense for Health Affairs.
    Scholten, Joel D., M.D., Associate Chief of Staff for                31
      Rehabilitation Services for the Veterans Affairs Medical
      Center, Washington, DC, Accompanied by David X. Cifu, M.D.,
      Principal Investigator, Chronic Effects of Neurotrauma
      Consortium, Department of Veteran Affairs.

    Questions for the Record.........................................    41

                                     (iii)

         RESEARCH, DIAGNOSIS, AND TREATMENT FOR TRAUMATIC BRAIN INJURY/
                          CONCUSSION IN SERVICEMEMBERS

                                  ----------

                          WEDNESDAY, DECEMBER 13, 2017

                               U.S. Senate,
                     Subcommittee on Personnel,
                                   Committee on Armed Services,
                                                        Washington, DC.
        The committee met, pursuant to notice, at 10:09 a.m. in
    Room SR-222, Russell Senate Office Building, Senator Thom
    Tillis (chairman of the subcommittee) presiding.
        Committee members present: Senators Tillis, McCaskill,
    Gillibrand, and Warren.

                OPENING STATEMENT OF SENATOR THOM TILLIS

        Senator Tillis. We will bring the committee to order.
        The witnesses on the first panel, please be seated.
        Before I make an opening statement, I have to tell you that
    I am in my fifth day of what they call monocular vision. That
    is where my optometrist finally convinced me that I should try
    putting a contact lens in one eye, and then get my other eye to
    adjust to a distance. But right now, there is a fight between
    which eye is winning, so I had to get my staff to print the
    text a little bit larger, so I could make sure that I could go
    through the statement. But if you see me walking around in
    circles, you will know why.
        [Laughter.]
        Senator Tillis. But thanks, everyone, for being here. I
    especially want to welcome some folks who will be speaking from
    North Carolina.
        Before we get started, the Personnel Subcommittee of the
    Senate Armed Services Committee meets this morning to receive
    testimony from government and civilian witnesses on traumatic
    brain injury, or TBI. TBI occurs along a continuum, ranging
    from mild TBI (MTBI) or a concussion to severe and penetrating
    brain injury. While treatment for TBI varies with the severity
    of the injury, management of mild TBI includes treatment of
    symptoms such as headaches, memory problems, dizziness, and
    poor concentration, followed by slow return to normal activity.
        From 2000 through the first half of 2017, the Department of
    Defense (DOD) diagnosed over 370,000 servicemembers with TBI.
    Of that total number of diagnoses, over 305,000 were mild TBIs.
        We know, however, that mild TBI is not a unique problem
    within the Department of Defense. It is a national problem.
    Last year, there were about 2.5 million emergency room visits
    related to concussions in the United States, and medical
    experts believe there were many more concussed individuals who
    did not seek medical care.
        As a Nation, we must pursue multiple approaches to
    understand better the chronic effects of mild TBI, including
    the long-term neurodegenerative problems associated with
    multiple concussive injuries.
        Today, we are fortunate to have a very distinguished group
    of witnesses joining us to discuss the diagnosis and treatment
    of mild TBI and to learn more about ongoing research on the
    effects of concussion on the brain.
        On our first witness panel, we have Dr. David Dodick,
    professor of neurology, sports neurology, and concussion
    program director at Mayo Clinic; Steve Devick, CEO of King-
    Devick Technologies; and Dr. Chris Miles, medical director of
    athletics and associate director of sports medicine fellowship,
    Wake Forest University School of Medicine.
        Dr. Miles, I already warned you that I want to welcome you
    because I have great regard for the academic programs at Wake.
    I have no regard whatsoever for your football program.
        [Laughter.]
        Senator Tillis. With that stipulated, welcome to the
    committee.
        Ranking Member Gillibrand?

                STATEMENT OF SENATOR KIRSTEN GILLIBRAND

        Senator Gillibrand. Thank you so much, Mr. Chairman, for
    holding this hearing and for really shining a spotlight on
    something that is so important to both of us and to the entire
    military.
        I join you in welcoming our witnesses today to discuss
    traumatic brain injury and the associated medical conditions. I
    am pleased that we have a variety of witnesses from different
    expertise inside and outside the government to discuss the
    current status of public and private advancements in diagnosis
    and treatment of TBI.
        This is a very important topic not only for the military
    but for society at large. Every parent of a high school athlete
    worries about his or her son or daughter suffering a
    concussion, another word for mild TBI, and the long-term
    potential consequences of this injury. What we learn while
    studying TBI in the military may also apply to the treatment of
    their concussive injuries.
        Certainly, we owe state-of-the-art care to our
    servicemembers who incur a traumatic brain injury as a result
    of their military duties. That is what this hearing is all
    about.
        But it is more than that. Accurately diagnosing TBI is
    complicated by symptoms that overlap with post-traumatic stress
    disorder (PTSD), such as difficulty in concentrating,
    irritability or angry outbursts, and memory loss.
        TBI and PTSD are commonly referred to as the signature
    wounds of war in our recent conflicts. Indeed, these are wounds
    of war, but there are other related wounds that also deserve
    more attention. We know that anxiety disorders, acute stress,
    sleep disorders, depression, substance use disorders, chronic
    pain, and other health conditions are also consequences of
    military service.
        Reports indicate that there have been more than 370,000
    servicemembers diagnosed with TBI from 2000 to 2017. At the
    same time, the Centers for Disease Control estimate that there
    are 2.8 million TBI-related emergency department visits,
    hospitalizations, and deaths a year.
        The damage is not limited to the traumatic brain injury
    itself. Based on VA [Veterans Affairs] data, we know that
    veterans with a history of TBI are at higher risk for suicide,
    and other data shows an increase in diagnosis of dementia and
    Alzheimer's disease and chronic traumatic encephalopathy,
    commonly referred to as CTE, for those who have suffered a
    concussion and traumatic brain injury.
        I am very concerned that servicemembers suffering from TBI,
    PTSD, and other service-connected conditions are too frequently
    disciplined and discharged with a bad-paper discharge for
    actions that are manifestations of these injuries.
    Servicemembers suffering from moderate or severe TBI can incur
    a lifetime of physical, cognitive, emotional and behavioral
    challenges. These challenges can manifest as drug- and alcohol-
    related misconduct, aggressive actions, charges, assaults,
    AWOLs [absent without leave], and failures to follow orders.
        These bad-paper discharges are too often a consequence of
    suffering from military-induced conditions and result in
    veterans not being eligible for care for these conditions from
    the VA.
        Military leaders must do a better job in taking these
    medical conditions into account when servicemembers are merely
    exhibiting the symptoms of their service-related injuries.
        Mr. Chairman, thank you for the hearing.
        Senator Tillis. Thank you, Senator Gillibrand.
        Gentlemen, each of you, we will just start from my left and
    go across, and you can spend up to maybe about 5 minutes on
    opening comments.

       STATEMENT OF DAVID W. DODICK, M.D., SPORTS NEUROLOGY AND
                CONCUSSION PROGRAM DIRECTOR, MAYO CLINIC

        Dr. Dodick. Mr. Chairman, Ranking Member, and distinguished
    members of the panel, it is, indeed, a privilege and honor to
    have this opportunity to appear before you today and provide
    testimony for this hearing on brain injuries in military
    servicemembers.
        As was said, I am a professor of neurology and founder and
    director of the concussion program at the Mayo Clinic in
    Phoenix, Arizona. I have been involved in the evaluation and
    management of patients with concussion for over 21 years, and I
    currently oversee the clinical and research concussion programs
    at Mayo Clinic, several of which are funded by the Department
    of Defense and the National Institutes of Health.
        I am the chair of the American Academy of Neurology's
    Concussion Committee, and I co-direct their annual Sports
    Concussion Conference. I am also the president-elect to
    International Concussion Society and co-founder of
    Concussion.org.
        We will start with, what is a concussion? A concussion is
    often referred to as a head injury, but it is not synonymous
    with a head injury. It is, instead, an injury to the brain
    itself. This injury involves individual cells in the brain and
    the wiring that connects them. There is both a primary and a
    secondary injury to the brain that results in dysfunction,
    disruption, and likely even death of living cells and their
    living connections.
        The primary injury occurs from the direct impact of the
    blunt force or the rapid movement of the brain within the
    skull. But the secondary brain injury occurs because of an
    inflammatory response that occurs and the inability of stunned
    and sick cells to generate the energy required for their
    repair.
        These primary and secondary injuries result in a breakdown
    of the normal electrical and chemical communication between
    cells, and it is this disruption of this extensive and
    interconnected communication grid that affects many sites in
    the brain and leads to the varied symptoms, several of which
    you already highlighted today, including physical, cognitive,
    emotional, and behavioral symptoms, that have an enormous
    impact on the individual, a very devastating one, and that
    actually affects the ability to function in daily life at work,
    at home, or in school.
        So why is concussion a military and a public health
    priority? I think concussion by any measure is a health
    priority. It is very common, obviously. It can lead to
    permanent symptoms in some, and progressive neurological
    disease in others. Yet, as was alluded to, it remains
    significantly underdiagnosed.
        For U.S. forces deployed in Afghanistan and Iraq in
    Operation Enduring Freedom, Operation Iraqi Freedom, and
    Operation New Dawn, blast exposure was the leading cause of
    concussion. Blast injury results in the rapid transmission of
    an acoustic wave through the brain tissue.
        Over the last 16 years, an estimated 320,000 U.S. troops,
    about 1 in 5, returning from active theater has sustained a
    concussion. Among those, almost half experienced symptoms
    consistent with post-traumatic stress or post-concussion
    syndrome.
        Therefore, not surprisingly, there is a heavy personal,
    family, and financial cost of these injuries to our men and
    women in uniform. The cost of care alone has increased from $21
    million in 2003 to over $650 million in 2010, and the median
    health care costs for veterans with traumatic brain injury is
    four times higher than those for veterans who do not experience
    traumatic brain injury.
        Among civilians, nearly 4 million concussions occur every
    year. Among these, sport-related concussion has obviously
    received the most media and public attention. While there are
    several reasons for this, chief among them, I think, is the
    devastating, long-term neurological consequences that have been
    demonstrated in amateur and professional athletes who
    participate in contact sports. This should be of particular
    concern to all of us because there are over 46 million children
    and adolescents in the United States who participate in sport,
    and they, in particular, are uniquely vulnerable to the
    complications of concussion because of the effects of brain
    injury on a developing brain that hasn't fully matured.
        Another vulnerable population that is often not talked
    about is women. Approximately 20 million women experience a
    domestic violence-related traumatic brain injury in this
    country every year. A recent study by the New York State Office
    for the Prevention of Domestic Violence revealed that 92
    percent of the women in domestic violence shelters were hit in
    the head by their partners more than once, and almost 1 in 10
    were hit more than 20 times in the past year.
        Concussion is underrecognized, as I said. While the
    reported number of concussions in this country is staggering,
    the actual number is much higher. It is estimated that only 1
    in 6 concussions, especially in sport-related concussions, are
    recognized and diagnosed. This is due to a lot of different
    reasons, which I will get to.
        One major reason for the lack of recognition of a
    concussive brain injury is the lack of symptoms. Just as brain
    injury from silent strokes and other silent lesions can occur
    in the brain, so too can silent concussions occur. These so-
    called subconcussive hits have been demonstrated to be far more
    frequent than actual concussions themselves, especially in
    contact sport athletes. These subconcussive injuries are
    especially important because the cumulative effect of
    subconcussive impacts results in a loss of the brain's normal
    architecture, and neurological and psychiatric consequences
    later in life.
        Much of the research on subconcussive hits has been
    performed in athletes involved in contact sports. If you look
    at many of these studies, some of which I have outlined in the
    testimony, you will see that even in individuals who have not
    experienced a concussion, there is a loss of normal brain
    function in those individuals, both at a youth level as well as
    at a collegiate and a professional level.
        These and other similar studies indicate that concussion is
    really the tip of the iceberg while subconcussive hits
    represent a larger, hidden danger that results in injury to the
    brain and lingering effects that are not being detected by
    current concussion assessment techniques.
        While the majority of individuals, as was said, experience
    symptom resolution from a single concussion within a week or
    two, post-concussion syndrome or the persistence of symptoms
    beyond 4 weeks occurs in about 10 percent to 20 percent of
    individuals after a single concussion.
        In children and adolescents, the percentage who experience
    persistent symptoms beyond 1 month has been shown to be at
    least 30 percent. Individuals who experience persistent
    symptoms may become functionally impaired or, indeed,
    permanently disabled.
        In addition to post-concussion syndrome, repeated
    concussions and subconcussive hits can lead to permanent
    cognitive and psychiatric impairment, a syndrome known as
    traumatic encephalopathy syndrome (TES). In individuals with
    traumatic encephalopathy syndrome, symptoms persist for longer
    than 2 years and progress over time.
        The symptoms and signs of TES, or traumatic encephalopathy
    syndrome, are similar to those seen in chronic traumatic
    encephalopathy, or CTE. As many of us know, CTE is a
    progressive degenerative brain disease that has been
    demonstrated to occur in individuals with a history of exposure
    to repeated head injuries.
        Unfortunately, and this is something maybe we will get
    into, at this time, we do not yet know how to identify people
    who are at-risk of developing CTE, nor do we yet have a
    reliable method to diagnose the disease before death or to
    intervene with treatment that prevents or disrupts the
    progression of the disease.
        I will end with the challenge that we as clinicians taking
    care of these patients face. The diagnosis, I think, of
    concussion is challenging even for experts. The reasons for
    this are several.
        First of all, many of the symptoms are subjective. They
    have to be reported by the athlete or the individual, and many
    times, they are not.
        Or the symptoms, as I said, may be absent. They may have
    had a subconcussive hit or a silent concussion or brain injury.
    A lot of times, the visible signs may not be present. Even for
    those of us who have been examining patients for over 20 years,
    the signs can be so subtle that they are not picked up in the
    routine bedside neurological examination.
        Finally, the detection of concussion often requires
    objective and quantitative tests that are not part of the
    routine neurological examination.
        Even when the diagnosis of concussion is made, the
    challenge of managing the patient is difficult because there
    are no pharmacological agents, not a single one, that has been
    shown to be effective in improving symptoms or interrupting
    that secondary injury cascade that occurs that I alluded to
    earlier.
        Another challenge for the clinician is knowing when the
    brain injury has stabilized. It has been well-demonstrated now
    that the brain injury continues and is not fully recovered long
    after the symptoms have resolved. So we are lulled into a sense
    of complacency, thinking that the examination is normal, the
    symptoms have resolved, and so that individual is ready to
    return to duty or ready to return to play, and that simply is
    not the case in many individuals.
        It is during this window of time where the brain is
    uniquely vulnerable to repeat injury that may result in
    symptoms that persist or, more seriously, may result in
    permanent injury.
        Determining if and when this window of vulnerability is
    closed is very challenging without expensive brain imaging that
    is not widely available, not feasible on a large-scale basis,
    and still not validated as a reliable clinical tool that can be
    used on an individual basis.
        So what is needed? Given the challenges in diagnosis,
    treatment, and the ability to provide patients with a
    prognosis, I think there is an urgent need for objective,
    widely available, and cost-effective tests that do the
    following: rapidly and accurately identify when a concussion
    has occurred, allowing for the removal of that individual from
    the activities that place them at further risk; indicate when
    it is safe for an individual to return to their previous
    activities, and this will avoid exposing an individual to a
    repeat and potentially devastating injury; predict who is most
    vulnerable to repeated concussions; and predict who is at-risk
    of long-term symptoms and chronic neurological impairment from
    repeated concussions and subconcussive impacts.
        We also need tests that accurately diagnose traumatic
    encephalopathy syndrome and chronic traumatic encephalopathy so
    that treatments, when developed, and I am optimistic they are
    coming, can prevent the progression or at least ameliorate the
    symptoms of these diseases.
        There is also, in addition to the diagnostic tests that are
    necessary, there is a serious need for treatments, treatments
    that can prevent these second injury cascades that are set in
    motion with that primary impact to the brain, because I think
    it is these second injury cascades that can persist for days,
    weeks, or longer that result in the progressive brain damage
    that occurs and likely results in the persistence of symptoms
    that these individuals experience.
        I also think there is a need for treatments that facilitate
    the brain's ability to repair, adapt, and compensate for
    previous injury; to prevent the development of chronic
    neurodegenerative diseases; and to interfere with the
    progression of those diseases when they have already begun.
        Until this occurs, I think we need to implement validated
    examination techniques that are sensitive for the detection of
    concussion immediately.
        I am confident of the dedication and commitment of the
    scientists and clinicians involved in this field, several of
    whom are in this room. I am optimistic that the scientific and
    treatment advances will be realized for the benefit of millions
    of men, women, and children affected by concussion.
        Mr. Chairman, Ranking Member, and distinguished members of
    the committee, thank you again for this opportunity and for
    your precious time and attention.
        [The prepared statement of Dr. Dodick follows:]

                  Prepared Statement by David W. Dodick, M.D.
                                  introduction
        Mr. Chairman, Ranking Member Gillibrand, and distinguished Members
    of the Committee, it is indeed a privilege and honor to have this
    opportunity to appear before you today and provide a testimony for this
    hearing on brain injuries in military servicemembers. I am a Professor
    of Neurology and the Founder and Director of the Concussion Program at
    the Mayo Clinic in Phoenix Arizona. I have been involved in the
    evaluation and management of patients with concussion for over 21
    years, and I currently oversee the clinical and research concussion
    programs at Mayo Clinic. I am the co-director of the neuroimaging
    laboratory that is conducting brain imaging research in patients with
    concussion. This research is funded by the Department of Defense and
    National Institutes of Health. I helped develop a laboratory at Mayo
    Clinic that investigates the underlying pathological mechanisms
    involved after a concussive brain injury and collaborate closely with
    our basic research scientists in attempting to identify new targets for
    treatment that could ameliorate some of the consequences of concussive
    brain injuries. I am the Chair of the American Academy of Neurology's
    Concussion Committee, Director of the Concussion educational courses at
    the American Academy of Neurology's Annual Meeting, and Co-director of
    the Annual Sports Concussion Conference of the American Academy of
    Neurology. I am the President-elect of the International Concussion
    Society and Co-founder of Concussion.org.
                             what is a concussion?
          A concussion, often referred to as a head injury, is
    instead an injury to the brain itself. The injury involves individual
    cells and the wiring that connects them.

          There is both a primary and a secondary injury. The
    primary injury occurs from the direct impact of the blunt force or the
    rapid movement of the brain within the skull. The second injury occurs
    because of an inflammation response and the inability of stunned and
    sick cells to generate the energy required to repair.

          The primary and secondary injuries result in a breakdown
    in the normal electrical and chemical communication between cells. The
    disruption of this extensive and interconnected communication grid
    affects many sites in the brain and leads to the many symptoms that
    patients report.

          The symptoms of concussive brain injuries are physical,
    cognitive and emotional,

          o  Physical symptoms include severe headache, nausea, vomiting,
    visual impairment, extreme sensitivity to light and sound, dizziness,
    vertigo, loss of coordination and balance, and in some cases, seizures.

          o  Cognitive symptoms include amnesia, confusion, and decreased
    ability to concentrate, plan, reason, remember, problem solve,
    communicate, and make decisions.

          o  The emotional symptoms of depression, agitation, impulsivity,
    aggression and violence, and rapid mood swings are often very
    distressing to patients and those around them.

          o  Add to this a disruption in sleep-wake patterns, and the
    result is a pervasive and devastating impact on an individual and her/
    his ability to function in daily life at work, home or school.
            why is concussion a military and public health priority?
        Concussion is by any measure a public and military health priority.
        Most importantly, concussion is very common and yet significantly
    underrecognized, and can lead to permanent symptoms in some and
    progressive neurological disease in others.
    Concussion is common
          For US forces deployed to Afghanistan and Iraq in
    Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OF), and
    Operation New Dawn (ONI)), blast exposure is the leading cause of
    concussion. Blast injury is the result of the rapid transmission of an
    acoustic wave through the brain tissue. Over the last 16 years, an
    estimated 320,000 US troops (1 in 5) returning from active theater has
    sustained a concussion, and among those, almost half experience
    symptoms consistent with post-traumatic stress disorder (PTSD) or post-
    concussion syndrome.

          Therefore, not surprisingly, there is a heavy personal,
    family, and financial cost of these injuries to our men and women in
    uniform. The cost of care alone has increased from $21 million in 2003
    to $646 million in 2010 and the median healthcare cost for veterans
    with traumatic brain injury is 4 times higher than those for veterans
    without traumatic brain injury.

          Among civilians, nearly 4 million concussions occur every
    year. Among these, sport-related concussion has received the most media
    and public attention. While there are several reasons for this, chief
    among them is the devastating long-term neurological consequences that
    have been demonstrated in amateur and professional athletes who
    participate in contact sport. This is of particular concern since there
    are over 46 million children and adolescents in the United States who
    participate in sport, and they are uniquely vulnerable to complications
    from concussion because of the effects on a developing brain.

          Another vulnerable population is women.

          o  Approximately 20 million women experience a domestic violence-
    related traumatic brain injury each year.

          o  A study conducted by the New York State Office for the
    Prevention of Domestic Violence (OPDV) revealed that 92 percent of the
    women in domestic violence shelters were hit in the head by their
    partners more than once, and 8 percent were hit in the head more than
    20 times in the past year.
    Concussion is under recognized
        While the reported number of recognized concussions that occur each
    year is striking, the actual number is much higher.

          It is estimated that only 1 in 6 concussions, especially
    in sport-related concussions, are recognized and diagnosed. This is due
    in part to underreporting:

          o  In a study of varsity athletes from the University of
    Pennsylvania, one-third of athletes who play a contact sport have
    hidden a concussion to stay in the game, and over 50 percent said they
    would be extremely unlikely or unlikely to report a concussion in a
    game situation.

          o  Among high school athletes, 70 percent report playing with
    concussion symptoms and 70 percent did not think that the injury was
    serious enough to report.

        Another major reason for the lack of recognition of a concussive
    brain injury is the lack of symptoms. Just as brain injury from silent
    strokes and silent lesions of multiple sclerosis can occur, so too can
    silent concussions occur. These so-called '``subconcussive'' hits, have
    been demonstrated to be far more frequent than actual concussions,
    especially in contact sport athletes.

          o  Offensive lineman in football can experience over 1000
    subconcussive hits to the head in a single collegiate season.

          o  The average child or adolescent playing youth ice hockey or
    football sustains over 200 hits to the head in a season.

        These subconcussive injuries are especially important because the
    cumulative effect of subconcussive impacts results in a loss of the
    brain's normal architecture and neurological and psychiatric
    consequences later in life. Much of the research on subconcussive hits
    has been performed in athletes involved in contact sport.

          o  For example, in a study of collegiate football athletes, there
    was a significant correlation between years of football played, the
    size of the brain's hippocampus (a vital brain structure involved in
    cognitive and emotional function), and cognitive performance. This
    association occurred in athletes with and without a prior diagnosis of
    concussion. (Figure 1).

                               Figure 1:

    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

          Similar results have been shown in youth athletes. In one
    study of male high school football athletes (ages 15-19) evaluated mid-
    season, those without a history of concussion showed alterations in
    working memory that correlated with abnormal changes on their
    functional brain MRI scans. (Figure 2).

                               Figure 2:

    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

        The effects of subconcussive brain injury has also been
    demonstrated in athletes participating in other contact sports. Changes
    in the integrity of the brain's wiring (white matter tracks) has been
    demonstrated in professional soccer players who did not report
    concussion (Figure 3), while small brain hemorrhages (bleeding) has
    been shown to occur in concussed and non-concussed hockey players
    (Figure 4).

                               Figure 3:

    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

                               Figure 4:

    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

        These and other similar studies indicate that concussion is the tip
    of the iceberg while subconcussive hits represent a large hidden danger
    that results in injury to the brain and lingering effects that are not
    being detected by current concussion assessment techniques.
    Concussion can result in persistent/permanent/progressive brain injury
            and neuropsychiatric impairment
        While the majority of individuals experience symptom resolution
    from a single concussion within several weeks, postconcussion syndrome
    (PCS), or the persistence of symptoms beyond 4 weeks, occurs in 10-20
    percent of individuals after concussion. In children and adolescents,
    the percentage who experience persistent symptoms beyond 1 month has
    been shown to be at least 30 percent. Individuals who experience
    persistent symptoms may become functionally impaired or permanently
    disabled.
        In addition to PCS, repeated concussions or subconcussive hits can
    lead to permanent cognitive and psychiatric impairment--a syndrome
    known as
        Traumatic encephalopathy syndrome (TES). In individuals with TES,
    symptoms persist for longer than 2 years and progress over time. The
    symptoms and signs of TES are similar to those seen in chronic
    traumatic encephalopathy (CTE). CTE is a progressive degenerative brain
    disease that has been demonstrated to occur in individuals with a
    history of exposure to repeated head injuries. You will hear much more
    about this devastating disease from my esteemed colleague, Professor
    Robert Stern.
                        the challenge for the clinician
        The diagnosis of concussion is challenging, even for experts. The
    reasons for this are several:

          Symptoms are subjective and may not be reported
          Symptoms may be absent (subconcussive brain injury)
          Visible signs may not be present
          Detection of concussion often requires objective and
    quantitative tests that are not part of the routine neurological
    examination

        Even when the diagnosis of concussion is made, the challenge of
    managing the patient is difficult because there are no pharmacological
    agents that have been shown to be effective in improving symptoms or
    interrupting the secondary injury that occurs in the brain.
        Another challenge for clinicians is knowing when the brain injury
    has stabilized. There is a period of instability in the brain that may
    last weeks or months beyond the time point when symptoms resolve.
        During this window of time, the brain is vulnerable to a repeat
    injury that may result in symptoms that persist, are more serious, or
    may become permanent. Determining if and when this window of
    vulnerability has closed is very challenging without expensive brain
    imaging that is not widely available, not feasible on a large-scale
    basis, and still not validated as a reliable clinical tool that can be
    used on an individual basis.
                                what is needed?
        Given the challenges in diagnosis, treatment, and ability to
    provide patients with a prognosis, there is an urgent need for
    objective, widely available, and cost-effective diagnostic tests that:

          Rapidly and accurately identifies when a concussion has
    occurred allowing for the removal of the individual from activities
    that place them at risk of a repeat and more devastating injury.

          Indicate when it is safe to return the individual to
    their previous activities. This will avoid exposing an individual to a
    repeat and potentially more devastating injury.

          Predict who is most vulnerable to repeat concussion(s).

          Predict who is at risk of long-term symptoms and chronic
    neurological impairment from repeat concussions and subconcussive
    impacts. This will facilitate the ability of health care providers and
    patients to make informed decisions about the risks associated with
    activities that increase their exposure.

          Accurately diagnose traumatic encephalopathy syndrome and
    chronic traumatic encephalopathy, so that treatments, when developed,
    can prevent the progression or ameliorate the symptoms of these
    diseases.

        There is also a serious need for treatments that can:

          Prevent the secondary injury cascades that are set in
    motion in the brain after the primary injury from the initial impact.
    These changes can persist for hours, days, and potentially longer after
    the initial impact. The ability to disrupt these damaging cascades must
    be a focus of future research since they lead to further damage that
    increase the risk of persistent symptoms and progressive brain
    degeneration.

          Facilitate the brain's ability to repair, adapt, and
    compensate for previous injury.

          Prevent the development of chronic neurodegenerative
    diseases in those at risk

          Interfere with the progression in those in whom these
    diseases have already begun.

        Until this occurs, diagnostic tools that have been validated and
    examination techniques that are sensitive for the detection of
    concussion should be implemented immediately.
        I am confident in the dedication and commitment of the scientists
    and clinicians involved in this field and optimistic that scientific
    and treatment advances will be realized for the benefit of millions of
    men, women and children affected by concussion.
        Mr. Chairman, Ranking Member Reed, and distinguished Members of the
    Committee, thank you again for this opportunity and for precious time
    and attention.
    References

         1.  Wojcik BE, et al. Traumatic brain injury hospitalizations of
    U.S. army soldiers deployed to Afghanistan and Iraq. Am J Prev Med.
    2010;38:S108--16.

         2.  Hoge CW, et al. Mild traumatic brain injury in U.S. Soldiers
    returning from Iraq. N Engl J Med.

         3.  Bell RS, et al. Military traumatic brain and spinal column
    injury: a 5-year study of the impact blast and other military grade
    weaponry on the central nervous system. J Trauma. 2009;66:S104-11.

         4.  Terrio H, et al. Traumatic brain injury screening: Preliminary
    findings in a U.S. Army Brigade Combat Team. J Head Trauma Rehabil.
    2009;24:14-23.

         5.  DOD worldwide numbers for TBI. http://dvbic.dcoemil/dod-
    worldwide-numbers-tbi.2016.

         6.  Frieden T, Collins F. Report to Congress on expenditures for
    activities on traumatic brain injury and psychological health,
    including post-traumatic stress disorder. U.S. Department of Defense.
    2010.

         7.   National Center for Injury Control and Prevention, Costs of
    Intimate Partner Violence Against Women in the United States. Atlanta:
    Centers for Disease Control and Prevention, 2003. Available online at:
    https://www.cdc.gov/violenceprevention/intimatepartnerviolence.

         8.  McCrea M, et al. Unreported concussion in high school football
    players Implications for prevention, Clin J of Sport Med 2004;14:13-17.

         9.  Talavage T., et al. Functionally-detected cognitive impairment
    in high school football players without clinically-diagnosed
    concussion. J Neurotrauma 2013. https://www.ncbi.nlm.nih.gov.pubmed/
    20883154.

        10.  Singh R, et al. Relationship of Collegiate Football Experience
    and Concussion With Hippocampal Volume and Cognitive Outcomes. JAMA.
    2014;311:18831888. doi:10.1001/jama.2014.331

        11.  Koerte 1K, et al. White Matter Integrity in the Brains of
    Professional Soccer Players Without a Symptomatic Concussion. JAMA.
    2012;308:1859-1861. doi:10.1001/jama.2012.1373

        12.  Helmer KG, et al. Hockey Concussion Education Project, Part 1.
    Susceptibilityweighted imaging study in male and female ice hockey
    players over a single season. J doi: 10.3171/2013.12.JNS132093.

        13.  Barlow KM. Postconcussion Syndrome. A Review. J Child
    Neurology. 2014; 31:57-67.

        14.  Reams N, et al. A Clinical Approach to the Diagnosis of
    Traumatic Encephalopathy Syndrome:A Review. JAMA Neurol. 2016;73:743-
    749. doi:10.1001/jamaneur01.2015.5015

        15.  Mez J, et al. Clinicopathological Evaluation of Chronic
    Traumatic Encephalopathy in Players of American Football. JAMA
    2017;318:360-370. doi:10.1001/jama.2017.8334

        Senator Tillis. Thank you.
        Dr. Devick?

     STATEMENT OF STEVEN D. DEVICK, M.D., CHIEF EXECUTIVE OFFICER
                     KING-DEVICK TECHNOLOGIES, INC.

        Dr. Devick. Mr. Chairman, Ranking Member Gillibrand, and
    distinguished members of the committee, it is a high honor for
    me to appear before you today.
        I am the CEO of King-Devick technologies (KDt). We develop
    objective, physical, electronically transmittable tests of eyes
    and brain function, which are validated in peer-reviewed
    medical journals, and that are able to be administered by
    laypersons.
        Before beginning, I would like to recognize Tregg Duerson,
    who is right there. Tregg is the son of NFL [National Football
    League] two-time Super Bowl winner Dave Duerson of the Chicago
    Bears and the New York Giants. Dave was a friend of mine. He
    was a brilliant scholar-athlete who graduated with honors from
    Notre Dame and later took his own life at 50 years old by
    shooting himself in the chest, so that his brain could be
    evaluated, because he was fairly certain he had chronic
    traumatic encephalopathy (CTE). He did, indeed, have an
    advanced case of CTE, although he was diagnosed with very few
    concussions in his career.
        Tregg is a highly successful businessman now, and he is
    also a former Notre Dame athlete. His dad was drafted by a
    Montreal baseball franchise, too. Tregg has often said, if he
    played baseball, he probably would still be alive today.
        But anyway, he has dedicated his life to doing something
    about CTE, which is a prevalent problem, called to attention
    again this week when the NFL had an issue with a diagnosis on
    the sidelines.
        As far as our products are concerned, in a DOD- and NCAA-
    [National Collegiate Athletic Association] funded study
    published in November 2017 in a peer-reviewed journal, it was
    found that King-Devick tests were shown to have the highest
    test-retest reliability when compared with more than a dozen
    other concussion tests. This article was authored by members of
    the CARE Consortium, the NCAA, and the Department of Defense.
        In May of 2017, King-Devick Technologies was one of a group
    of participants ranging from Federal Government
    representatives, private industry, professional medical
    research and veteran communities invited to compete in the VA's
    annual Brain Trust InnoVAtion summit. King-Devick Technologies
    was selected as a winner of the 2017 InnoVAtion awards for its
    brain injury remediation and rehabilitation applications
    utilizing technology that allows for faster recovery from TBI
    and from concussions as well.
        Because the diagnosis of MTBI concussions in servicemembers
    and everyone often relies on history alone, the DOD-VA clinical
    practice guidelines indicate that a confirmatory, objective
    test for concussions that could be used to direct support and/
    or predict outcomes would be desirable. In 2016, a group of
    military officers who were doctors identified the King-Devick
    test as a solution.
        The quote from their article was, ``We recommend the King-
    Devick test be utilized as a supplementary screening tool in
    those who have suffered a concussive event. Having preinjury
    King-Devick test data will allow more precise determination.
    Therefore, we recommend the test be included as a baseline for
    all warfighters prior to exposure to risk of MTBI. Having a
    validated, rapid, easy-to-assess brain-screening test can
    assist frontline providers in making return-to-duty
    decisions.''
        Since 2011, more than 110 peer-reviewed articles have been
    published in elite medical journals validating these King-
    Devick applications. These articles describe the products as
    clinical biomarkers, not serum biomarkers, and other aspects of
    the test helped in remove-from-play decisions. The
    effectiveness of this detection led to its cobranding with the
    Mayo Clinic, the first cobranding agreement ever entered into
    throughout Mayo Clinic's 150-year history. The test, now known
    as the King-Devick test in association with Mayo Clinic, is the
    most validated sideline screening tool for concussions
    currently available.
        Changes in performance can easily be transmitted to inform
    diagnostic and related clinical service provision and guide
    clinical decision-making from theater to medical treatment
    facility.
        Thank you.
        [The prepared statement of Dr. Devick follows:]

                       Prepared Statement by Steve Devick
        Mr. Chairman, Ranking Member, and distinguished Members of the
    Committee, it is a high honor for me to appear before you today.
        I am the Chief Executive Officer of King-Devick technologies, inc.
    We develop objective, physical and electronically transmittable tests
    of eyes and brain function which are validated in peer reviewed medical
    journals and are able to be administered by lay persons. Before
    beginning I'd like to recognize Tregg Duerson. Tregg is the son of NFL
    two-time Super Bowl winner Dave Duerson of the Chicago Bears and NY
    Giants. Dave was a friend of mine, brilliant scholar athlete who
    graduated with honors from Notre Dame and later took his own like at 50
    years old by shooting himself in the chest, so that his brain could be
    evaluated for chronic traumatic encephalopathy (CTE). He did indeed
    have an advanced case of CTE, although was diagnosed with very few
    concussions in his career. Tregg is himself a high-quality individual,
    who is also a former Notre Dame football player and successful
    businessman. For Tregg, prevention of this neuro-degenerative disease,
    which can only be caused by repetitive head trauma, is one of his
    life's priorities.
        Improving the population health of servicemembers at risk for
    traumatic brain injury (TBI) is fundamental to the DOD- operated
    Military Health System (MHS). A key role involves supporting the
    medical personnel and programs that address the needs of servicemembers
    who have had and/or are at risk for TBI as well as mild TBI (mTBl),
    often referred to as a concussion, both on the battlefield and off. In
    a DOD/NCAA funded study, published in November, 2017, in the peer
    reviewed journal, Sports Medicine, it was found that the King-Devick
    test was shown to have the highest test-retest reliability when
    compared with more than a dozen other concussion tests. This article
    was authored by members of the Care Consortium, the NCAA, and the
    Department of Defense. \1\
    ---------------------------------------------------------------------------
        \1\ Broglio SP, Katz BP, Zhao S, McCrea M, et al. Test-retest
    reliability and interpretation of common concussion assessment tools:
    finding from the NCAA-DOD CARE Consortium. Sports Med. 2017 Nov 14.
    doi: 10.10071s40279-017-0813-0.
    ---------------------------------------------------------------------------
        An estimated 10 to 30 percent of concussions result in a prolonged
    recovery period (i.e., post-concussion syndrome) and individuals can
    report new/persistent/worsening symptoms weeks, months, or sometimes
    years post-injury that require ongoing intervention? In addition,
    servicemembers exposed to repetitive concussive or sub-concussive
    events, especially those lacking early identification and accurate
    diagnosis of prior TBI, are at high risk for a myriad of long-term
    negative consequences to brain health including the development of
    neurodegenerative diseases as Dr. Dodick described. \3\
    ---------------------------------------------------------------------------
        \3\ McKee AC, Cairns NJ, Dickson DW, Folkerth RD, et al. The first
    NINDS/NININ consensus meeting to define neuropathic criteria for the
    diagnosis of chronic traumatic encephalopathy. Acta Neuropathol.
    2016;131:75-86.
    ---------------------------------------------------------------------------
        KDt was recently one of a group of participants ranging from the
    Federal Government, private industry, professional medical research,
    and veterans communities, invited to compete in the VA's annual Brain
    Trust InnoVAtion Summit. KDt was selected as a winner of the 2017 VA
    InnoVAtlon Award for its brain injury remediation and rehabilitation
    applications utilizing technology that allow for faster recovery from
    TBI and concussion.
        These applications are a readily available resource for the DOD to
    meet the unique needs of servicemembers. Some of the benefits are:

          Rapid, reliable, mobile, quantitative screening and
    detection of mTBl eliminates subjectivity,
          Immediate administration by laypersons/caregivers in real
    time, both in theater and out, which facilitates earliest possible
    intervention and treatment
          Validated, objective, physical performance metrics inform
    the full spectrum of clinical decision making with high strength of
    evidence
          Cost-effectiveness and ease of implementation expedites
    screening and monitoring of all target populations, including acute and
    chronic care
          Telehealth compatibility extends applicationsfor use In
    treatment and rehabilitation of mTBI

        The 2016 Department of Defense (DOD), Department of Veterans
    Affairs (VA) and Clinical Practice Guideline (CPG) for the Management
    of Concussion-mTBI benchmarks current recommendations and protocols for
    servicemembers. \2\ In addition to including a review of earlier
    reports, the DOD/VA/CPG serves as an evidence-based resource for
    procedures, recommendations, and health care information relative to
    the comprehensive continuum of mTBl in the Armed Services. The DOD/VA/
    CPG recommends that early identification and management of mTBI/
    concussion in servicemembers close to the time of injury is best for
    providing optimal care and preventing persisting symptoms. \2\ Because
    the diagnosis of mTBI/concussion in servicemembers often relies on
    history alone, the DOD/VA/CPG evidence indicates that:
    ---------------------------------------------------------------------------
        \2\ The Defense Health Agency 2016 Report. Downloaded from: https:/
    /health.mil/ReferenceCenter/Reports/2017/06/08/Defense-Health-Agency-
    2016-Stakeholder-Report. Accessed August 21, 2017.

            ``. . . a confirmatory objective test [for concussion-mTBI] . .
            . that could be used to direct support treatment and/or predict
    ---------------------------------------------------------------------------
            outcomes would be desirable . . . '' \2\

    and the King-Devick Test was identified as a solution to this need in a
    2016 a peer reviewed article published in the Journal for the
    Neurological Sciences which was authored by U.S. military officers:

             ``. . . we recommend the King-Devick Test be utilized as a
            supplementary screening tool in those who have suffered an MTBI
            event . . . having pre-injury K-D test data will allow a more
            precise determination; therefore we recommend that this test be
            included as a baseline test for all warfighters prior to
            exposure to risk of mTBI/concussion . . . having a validated,
            rapid, easy-toassess mTBI brain screening test can assist
            frontline providers in making [return-to-duty) decision'' \4\
    ---------------------------------------------------------------------------
        \4\ Walsh DV, Capo-Aponte JE, Beltran T, Cole WR, et al. Assessment
    of the King-Devick Test for screening acute mTBI/concussion in
    warfighters. J Neurol Sci. 2016;370:305-309.

    Further, the DOD/VA/CPG confirms the existence of a critical gap
    involving objective physical assessment of individuals suspected of
    ---------------------------------------------------------------------------
    mTBI as stated in the reported finding that:

            ``. . . unfortunately, at this time, evidence does not support
            the use of any laboratory (i.e., serum biomarkers),
            neuroimaging, or physiological (i.e., EEG) test'' for the
            definitive diagnosis of mTBI or to direct treatment. \2\

        As a solution to this issue, this product provides a validated
    objective physical measure which both assists in the diagnosis and
    treatment of TBI, and serves as a real-world screening tool for
    identification of neurological insult.
                 concussion/mtbi solutions for servicemembers:
        Since 2011 more than 110 peer reviewed articles have been published
    in elite medical journals validating these applications (please see
    Abstracts Summary available at https://kingdevicktest.com/
    ResearchAbstracts). These articles demonstrate the efficacy of these
    products as:

          clinical biomarkers to aid in the prompt and accurate
    diagnosis of mTBI;
          a remediation tool in the rehabilitation of mTBI and
          an outcome measure for monitoring function relative to
    sleep deprivation, hypoxia, and progressive neurodegenerative diseases

        The effectiveness of this product in concussion detection led to
    its co-branding with the Mayo Clinic, the first co-branding agreement
    ever entered into throughout Mayo Clinic's 150-year history. The test,
    now known as the King-Devick Test in association with Mayo Clinic is
    the most validated sideline tool for the screening and diagnosis of
    concussion currently available.
        We propose full scale adoption and integration of this test and
    related suite of mTBI/concussion applications by the DOD for
    servicemembers and the MHS. It has been assessed across a variety of
    cohorts that include all levels of contact sports (football, boxing,
    mixed martial arts, rugby, hockey). The test provides an objective
    performance measure that utilizes eye movement, attention,
    concentration and language function. These functions involve the
    integration of brainstem, cerebellum, and cerebral cortex, and K-D Test
    performance correlates with suboptimal brain function in concussion/
    mTBI. A 2015 meta-analysis and systematic review confirmed K-D Test as
    a highly sensitive (86 percent) and specific (90 percent) rapid
    objective sideline tool for the detection of concussion. \5\ These
    products are tablet-based and can be routinely administered by non-
    physician health care professionals and laypersons alike. Performance
    metrics are electronically stored on the tablet for synchronization to
    EHR databases when convenient. Changes in performance can be easily
    transmitted to inform diagnostic and related clinical service provision
    and guide clinical decision making from theater to medical treatment
    facility.
    ---------------------------------------------------------------------------
        \5\ Coldren RL, Russell ML, Parish RV, Dretsch M, et al. The ANAM
    lacks utility as a diagnostic or screening tool for concussion more
    than 10 days following injury. Mil Med. 2012;177:179-83.
    ---------------------------------------------------------------------------
        These products are utilized by many elite sports professional
    sports leagues, college and schools around the world.
        The strengths of these applications are in their versatility to
    address a myriad of issues that can dramatically improve individual and
    population health of servicemembers while reducing negative impacts of
    mTBI and its sequelae.

        Senator Tillis. Thank you.
        Dr. Miles, I should say that my senior member from North
    Carolina probably has a decidedly different view of the Wake
    program, so you have some balance there in the delegation. You
    can provide your opening statement.

     STATEMENT OF CHRISTOPHER M. MILES, M.D., ASSOCIATE DIRECTOR,
           SPORTS MEDICINE FELLOWSHIP, WAKE FOREST UNIVERSITY

        Dr. Miles. Very good, sir. Chairman Tillis, Ranking Member
    Gillibrand, and honorable members of the committee, thank you
    for this opportunity to discuss concussion from an academic
    clinician's perspective.
        I currently serve as the medical director of athletics and
    the head team physician for Wake Forest University, the
    associate director of the Primary Care Sports Medicine
    Fellowship at the School of Medicine, and the site principal
    investigator to the NCAA- and Department of Defense-sponsored
    CARE Consortium Research Study.
        As a former college football player who has experienced
    concussion, I have seen all sides of this condition. Unlike
    many medical diagnoses, concussion is not yet well understood.
    This enigmatic condition not only has different presentations,
    causes, and outcomes for patients, but it also has very little
    evidence-based guided evaluation and management options, though
    research is changing this. Much of the management
    recommendations for sport-related concussion have been driven
    by consensus statements released over the last decade.
        The most recent release of this came in 2017 as the result
    of the fifth International Consensus Conference on Concussion
    in Sport. Although the conference makes a distinction between
    sport-related concussion and nonsport-related concussion, many
    of the key principles are shared between these two entities.
        I have been fortunate to be part of several different
    research studies investigating the natural history of the
    condition, evaluation tools, and management options. The
    largest and most well-known of these is the NCAA and DOD CARE
    study. As part of the Grand Alliance, the CARE study is
    designed to answer scientific questions about the course and
    neurobiology of concussion in a definitive way. With 30 sites,
    including the four military academies, over 37,000 athletes and
    cadets have been enrolled, and over 2,500 concussive events
    have been captured and studied. This is nearly 100 times the
    number of subjects in the average concussion study.
        Through this study, the NCAA and DOD Grand Alliance is
    setting the standard for concussion research and clinical care.
    The collaboration between universities and the military
    academies has provided data that is absolutely unprecedented.
        Although it has been just over 3 years since its inception,
    this consortium has impacted the practice of concussion
    management in several ways. Perhaps most important to this
    committee is the finding that, historically, there have been
    some undue delays in the return to duty of nonathlete cadets.
    This finding has changed management of concussion at the
    academies.
        Unfortunately, the consortium is at a watershed moment.
    Funding for continuation of this highly important research has
    expired. An application for CARE 2.0, a study to further our
    knowledge, especially in areas of neurobiology and long-term
    outcomes, was declined by the Department of Defense.
        The NCAA has agreed in principle to supporting the CARE 2.0
    initiative, but funding from the DOD has not yet been secured.
    It is my hope that this committee sees the benefit in
    continuing this highly important work.
        In addition to the work with the CARE study, our group at
    Wake Forest is involved in force sensor research through helmet
    and mouthpiece sensors, post-concussive biomarker data, and the
    role of genetics in post-concussion syndrome. We are also
    particularly active with the study of concussions in youth
    football.
        Also being studied are blood and saliva tests to determine
    if we can predict which patient will have prolonged symptoms,
    and brain imaging techniques that may provide similar
    predictability information.
        These types of studies are vitally important as,
    clinically, no two concussions are created equal. It is crucial
    that we develop an objective test that will help diagnose and
    guide the management of this condition.
        There are current tools, such as the King-Devick, but there
    is not yet a gold standard for concussion testing. If an
    imaging or a blood test similar to what we have for evaluating
    heart attacks were to be discovered, the evaluation and
    management could be standardized.
        Perhaps of equal importance, if we were able to identify a
    gene that may predispose patients to the long-term sequelae of
    concussion, we could counsel those patients on avoiding
    potentially higher risk activities.
        We are still too early in the study process of biomarkers,
    imaging, and gene identification to include them in clinical
    decision-making. More research funding will help to determine
    if these advances are, in fact, predictive and, if so, which
    ones do this the best.
        I believe the importance of the collaboration between
    military and civilian clinicians and researchers in tackling
    the best way to diagnose and treat concussions is crucial.
        Although the causes of injuries may be different, though
    certainly not always, the importance of being able to
    accurately diagnose and provide the best treatment is the same.
        When a condition does not have an objective test that
    cannot be manipulated, there is always the risk that symptoms
    may be feigned. A student or soldier that wants to avoid an
    activity could falsely report symptoms. A truly objective test
    will assist in guiding not only diagnosis of actual concussion
    injuries but will allow for a more rapid return to learning and
    activity in those who would not test positive.
        Many entities have helped raise awareness of concussion to
    our society at large. We are likely more educated on the
    prevention and identification of concussion than ever before.
    Most athletes and military personnel recognize the importance
    of this topic for their safety and well-being.
        However, there is still great work to be done. We must make
    activities safer and less of a burden on long-term health and
    the health care system. Researchers and clinicians must
    continue to grow the data needed to make evidence-based
    recommendations and funding bodies must continue to make this
    topic a priority.
        Thank you for your time, and I look forward to your
    questions.
        [The prepared statement of Dr. Miles follows:]

                  Prepared Statement by Christopher Miles, MD
        Chairman Tillis, Ranking Member Gillibrand, and Honorable Members
    of the Committee, thank you for this opportunity to discuss concussion
    and its research, evaluation, and management from an academic
    clinician's perspective.
        My name is Christopher Miles, MD, and I currently serve as the
    medical director of athletics for Wake Forest University, the associate
    director of the primary care sports medicine fellowship at Wake Forest
    University School of Medicine, and as the site Principal Investigator
    (PI) for the National Collegiate Athletic Association (NCAA)-Department
    of Defense (DOD) sponsored CARE Consortium research study. In addition,
    I maintain other academic and research duties involving concussion
    (also referred to as mild traumatic brain injuries). As a former
    college football player who has experienced concussion injuries as an
    athlete, I have seen all sides of this condition.
        Unlike many medical diagnoses, concussion is not yet well
    understood. This enigmatic condition not only has different
    presentations, causes, and outcomes among patients, it also has very
    little evidence-based guided evaluation and management options. Through
    research, this is changing; we are growing our understanding of the
    many facets of this condition.
        Much of the management recommendations have been driven by
    consensus statements released over the last decade. The most recent
    release of this came in 2017, as a result of the Fifth International
    Conference on Concussion in Sport, held in Berlin in 2016. This
    conference gathers scientists and clinicians to evaluate current
    research to help guide evaluation and management of sport related
    concussion (SRC). Although the conference makes a distinction between
    SRC and non-SRC, many of the key principals are shared between these
    two entities.
        A commonly accepted definition of SRC is:
        [A] traumatic brain injury induced by biomechanicalforces. Several
    common features that may be utilized in clinically defining the nature
    ofa concussive head injury include:

          SRC may be caused either by a direct blow to the head,
    face, neck or elsewhere on the body with an impulsive force transmitted
    to the head.

          SRC typically results in the rapid onset of short-lived
    impairment of neurological function that resolves spontaneously.
    However, in some cases, signs and symptoms evolve over a number of
    minutes to hours.

          SRC may result in neuropathological changes, but the
    acute clinical signs and symptoms largely reflect a functional
    disturbance rather than a structural injury and, as such, no
    abnormality is seen on standard structural neuroimaging studies.

          SRC results in a range of clinical signs and symptoms
    that may or may not involve loss of consciousness. Resolution of the
    clinical and cognitive features typically follows a sequential course.
    However, in some cases symptoms may be prolonged.

        The clinical signs and symptoms cannot be explained by drug,
    alcohol, or medication use, other injuries (such as cervical injuries,
    peripheral vestibular dysfunction, etc.) or other comorbidities (e.g.,
    psychological factors or coexisting medical conditions. (McCrory, 2017)
        This definition has stayed consistent since 2000, though prior to
    that an exact or reproducible definition did not exist--making studies
    performed prior to that date hard to interpret and non-recognizable.
        I have been fortunate to be a part of several different research
    studies investigating the natural history of this condition, evaluation
    tools, and management options.
        The largest and well known of these studies is the NCAA-DOD CARE
    study, the largest study of concussion to date. \1\ As part of the
    NCAA-DOD Grand Alliance, the CARE study is designed to answer
    scientific questions about the course and neurobiology of concussion in
    a definitive way. With 30 sites, including four military academies,
    over 37,000 athletes and cadets have been enrolled and over 2,500
    concussion events have been captured and studied--nearly 100 times the
    number of concussions in the average concussion study.
    ---------------------------------------------------------------------------
        \1\ For the specific details on the Grand Alliance and the CARE
    study, please see www.careconsortium.net.
    ---------------------------------------------------------------------------
        Through this study, the NCAA-DOD Grand Alliance is setting the
    standard for concussion research and clinical care. The collaboration
    between colleges and universities at all levels of athletic
    participation and the military academies has provided data that is
    absolutely unprecedented. Although it has been just over three years
    since its inception, this consortium has impacted the practice of
    concussion management in several ways. The identification that there is
    a difference between ``asymptomatic'' and being ready to return to
    contact has improved safety. Perhaps most important to this Committee
    is the finding that, historically, there has been some undue delay in
    return to duty of non-athlete cadets. This finding has changed
    management of concussion at the academies.
        Unfortunately, the consortium is at a watershed moment. Funding for
    continuation of this highly important research has expired. An
    application for CARE 2.0, a study to further our knowledge--especially
    in areas of neurobiology and long-term outcomes--and capitalize on the
    work already invested, was declined by the DOD. The NCAA has agreed in
    principle to supporting the CARE 2.0 initiative, but the funding from
    the DOD has not yet been secured. It is my hope that this Committee
    sees the benefit in continuing this highly important work.
        In addition to the work with the CARE study, our research group at
    Wake Forest University School of Medicine is also involved in force
    sensor research through helmet and mouth piece sensors, as well as with
    post-concussion biomarker data. Our bioengineering department has been
    a leader in helmet sensor research and highly active in the study of
    concussion in youth football. Our group has also been studying the role
    of brain injury bio-markers (substances released into the bloodstream
    after brain injury) and the role of particular genes that may
    predispose an individual to post-concussive syndrome.
        Other groups across the country are studying similar blood tests to
    determine if we can predict which patients will have prolonged symptoms
    and which may recover sooner. Similar areas of study both with our
    group at Wake Forest University School of Medicine and other
    institutions are looking for brain imaging techniques that may provide
    similar predictability information.
        These types of studies are vitally important; clinically, no two
    concussions are created equal. It is crucial that we develop an
    objective test that will help diagnose and guide the management of
    concussion. There are currently tools, such as neurocognitive testing,
    balance testing, and eye-tracking testing, that provide some insight,
    but there is no gold standard for concussion testing.
        If a blood test or an imaging test, similar to what we have for
    evaluating heart attacks, were to be discovered, the evaluation and
    management of concussion could be standardized. Perhaps of equal
    importance, if we were able to identify a gene that may predispose
    patients to the long term sequela of concussion, we could counsel those
    patients on avoiding potentially higher risk activities. Attempts to
    identify genes such as the apolipoprotein E (APOE) as potential risks
    for concussion to date have been inconclusive.
        We are still too early in the study process of biomarkers, imaging,
    and gene identification to include them in the clinical decision-
    making. More research funding will help to determine if any of these
    advances are in fact predictive and, if so, which ones do this the
    best.
        We currently know that concussion risk and natural history appears
    to be different in females and males. As more females become active in
    military and athletic activities, the importance of identifying and
    understanding these differences becomes greater. If we can identify a
    role of hormonal fluctuation in the course of this condition, treatment
    options for both men and women may be improved. We performed a pilot
    study looking at the use of progesterone in the acute phase of
    concussion to determine if this type of study would be feasible.
    Although the study was not powered for the outcome of the drug
    intervention, we were able to determine that this type of study was
    possible. Others in the research arena continue to investigate
    treatment options and unfortunately to date there are no good options.
        I believe the importance of the collaboration between military and
    civilian clinicians and researchers in tackling the best way to
    diagnose and treat mild traumatic brain injuries is crucial. The
    findings from research in one group are certainly applicable to the
    care of the other. Although the causes of injuries may be different
    (though certainly not always), the importance of being able to
    accurately diagnose and provide the best treatment is most often the
    same. When a condition does not have an objective test (blood test,
    imaging) that cannot be manipulated, there is always the risk that
    condition may become a condition of convenience. The risk that a
    student who does not want to take a test or a soldier who does not want
    to participate in a certain activity may feign symptoms of a concussion
    is real. A truly objective test will assist in guiding not only
    diagnosis of actual concussion injuries, but allow for a more rapid
    return to learning and activity in those who may not test positive.
        Medical organizations, athletic groups, the military, and the media
    have helped raise awareness of concussions to society at large.
    Parents, coaches, and other superiors are likely more educated on
    concussion prevention and treatment than ever before. Similarly, most
    athletes and military personnel recognize the importance of this topic
    for their safety and well-being.
        However, there is still great work to be done. Evaluation,
    diagnosis, and treatment of concussion should be just as standardized
    as other injuries or illnesses, driven by solid evidence-based
    practice. We must make activities safer, more enjoyable, and less of a
    burden on long-term health and the health care system.
        Researchers and clinicians must continue to grow the data needed to
    make evidence-based recommendations. Funding bodies must continue to
    make this topic a priority.
        Thank you for your time, and I look forward to your questions.
    References:
        McCrory P, Meeuwisse WI-I, Dvorak J, et al. Consensus statement on
    concussion in sport: the 5th international conference on concussion in
    sport held in Berlin, October 2016. Br J Sports Med
        McCrory P, Meeuwisse WH, Aubry M, et al. Consensus statement on
    concussion in sport: the 4th international conference on concussion in
    sport held in Zurich, November 2012. BrJ Sports Med 2013 ; 47;250-8.
        www.careconsortium.net

        Senator Tillis. Thank you all.
        I have a question for Dr. Devick. Can you give me an idea
    of the cost, the timing of the tests, and where these tests can
    be administered?
        Dr. Devick. Did you say the cost?
        Senator Tillis. Yes.
        Dr. Devick. The cost is less than $20 per year per
    individual for unlimited testing. So there is very little cost
    involved.
        Senator Tillis. When is the test administered? After
    somebody has experienced an injury that you are testing for? Or
    is it something that you do on a recurring basis to a larger
    population?
        Dr. Devick. The sideline application that we are partners
    with Mayo Clinic on is at the point of sidelines, immediately
    after the concussion occurs.
        Senator Tillis. Is this a sort of test that could be
    reliably administered in a battlefield situation?
        Dr. Devick. Yes. As a matter of fact, thousands of teams
    and leagues around the world use King-Devick tests, and they do
    it on a noisy--the NFL doesn't use it yet, but I think they
    will get there. The Canadian Football League does. All of the
    administration can be done on the sidelines where there is
    noise and whatever else goes on on the sidelines.
        It is just a 2-minute test that checks your ability to move
    your eyes and----
        Senator Tillis. What are the other alternative tests? Give
    me some idea. I would guess they would be competing against a
    test that has obviously gotten a lot of attention. But what
    does the landscape look like out there, in terms of options?
        Dr. Devick. Right now, it is kind of a three-legged tool
    for sideline testing. One is oculomotor function, which is what
    our test applies to. One is balance. Then one is cognition,
    like, ``Who is the President? What day is it?,'' those kinds of
    questions.
        I think that when you apply all three of those that can be
    done quickly on the sideline, you get very high specificity and
    sensitivity.
        So as Dr. Miles said, ours is a tool. There are other tools
    that they should be combined with. But again, the whole suite
    of tools doesn't take long, and it can be done on the
    sidelines.
        Senator Tillis. Is there any data out there with respect to
    false positives? I mean, is it highly accurate? Do we sweep in
    those that may not have suffered an injury?
        Dr. Devick. The false positives we aren't nearly as
    concerned about as false negatives.
        Senator Tillis. Right.
        Dr. Devick. So the specificity in the biggest meta-analysis
    ever done on our products, they combined 15 studies together,
    and the sensitivity was 86 percent, and the specificity was 90
    percent, which is higher than anything like a Pap smear or
    anything else, and it is done on the sidelines.
        No, it is not 100 percent, but it is certainly a better
    indication than asking a player how he feels.
        Senator Tillis. Okay.
        Anyone who has information on it, what research has been
    done--this actually speaks to something I will spend more time
    on with the second panel, but Senator Blumenthal and I and
    others on the Veterans' Affairs Committee are worried about PTS
    and TBI that may have resulted in behavioral problems that
    ultimately precipitated an other-than-honorable discharge.
        So what research has been done on the population who
    experience a concussion or something on the spectrum of TBI
    where there are measured behavioral differences in the person
    after that are virtually unrecoverable? They just become a part
    of who they are, in this case, a soldier.
        Anyone who has any information on that, I would like to
    hear it.
        Dr. Devick. The DARPA [Defense Advanced Research Projects
    Agency], DOD, VA study just done by Dr. Scher found with
    comorbidity--that is what you described, where there is PTSD or
    something else in addition to a concussion. She found, in this
    article that is pending publication that Dr. Dodick may know
    more about than I, that when there is comorbidity, the defect
    under oculomotor test on King-Devick test----
        Senator Tillis. Dr. Dodick or Dr. Miles?
        Dr. Miles. So part of the CARE Consortium study is looking
    at behavioral changes long term, both acutely and in the long-
    term setting. There is some speculation, and I think some data
    to support, that premorbid conditions, such as depression,
    anxiety, those sorts of things, may also play into some of the
    behavioral changes that occur post-concussively.
        Senator Tillis. Dr. Dodick?
        Dr. Dodick. Yes. I would say there actually has been quite
    a bit of work, especially imaging work, that has been done with
    some of these individuals. What they found, first of all, is
    actually the temporal lobe, which is sometimes referred to as
    the limbic lobe, where many of the structures in the brain are
    housed that govern and control emotional function, is altered.
    Its architecture is altered after a concussive brain injury.
    Such that I saw a recent study indicating that the amygdala,
    which is part of the brain that drives the fear response, part
    of the brain that is responsible for impulsivity, aggressive
    behavior, is actually enlarged after a concussive brain injury,
    while other areas in the temporal lobe, such as the
    hippocampus, for example, which is what allows us to remember
    what we are being told, actually shrinks over time.
        Senator Tillis. So are you able to determine a change
    without having a reference point, let's say an image of the
    brain prior to the event?
        Dr. Dodick. Very good question. So not exactly, but the
    studies that I am talking about compare to age- and sex-
    matched, or age- and gender-matched controls.
        Obviously, it would be ideal to have a preinjury MRI
    [magnetic resonance imaging] scan on all these individuals, but
    it is not feasible or practical, so it ends up being compared.
    It is within the 95 percent confidence interval of change in
    that individual.
        So there are a variety of imaging studies. There are also
    some molecular studies that have been done showing an
    upregulation in something called the corticotropin receptor,
    which is a sensitive surrogate marker of stress response.
        So there are physiological, biological, and imaging changes
    that occur in individuals who exhibit this impulsive-aggressive
    behavior after a traumatic brain injury.
        Senator Tillis. Very good. Thank you all.
        Ranking Member Gillibrand?
        Senator Gillibrand. Thank you, Mr. Chairman.
        While the symptoms of TBI may appear right away, others may
    not be noticed for days or months after injury or until the
    person resumes everyday activities. In some cases,
    servicemembers do not recognize or admit that they are having
    problems or understand the problem and how the symptoms they
    are experiencing impact their daily activities.
        Are you looking at delayed onset TBI in your research?
        Dr. Miles. Absolutely. One of the nice pieces of the CARE
    study are the data points currently during symptom stage, in
    the asymptomatic stage, once they have returned and then again
    at the 6-month follow-up. The hope with CARE 2.0 is to continue
    that out for many years to see if there are potentially
    behavioral changes, mood changes, et cetera, that may occur.
        That is part of the reason why the funding is so important,
    so that we can complete that part of the study.
        Senator Gillibrand. Do you think it is getting enough
    research? Do you think there is any way we can integrate
    awareness of delayed onset into policies and procedures at the
    DOD and VA?
        Dr. Miles. I think, just simply, as you mentioned, that it
    is out there, and we should be aware of it and educating not
    only physicians but commanders of units and those sorts of
    things that this is certainly something they should watch for.
        Dr. Dodick. I alluded to the secondary injury cascades that
    are set in motion after the primary impact, and I think it is
    these inflammatory cascades that are set in motion that
    continue for days, weeks, or even months that are responsible
    for some of the delayed onset symptoms and signs that you are
    talking about.
        We and others are doing preclinical work in animal models
    showing what some of those changes are, because that allows us
    to sort of tee up high-value targets for therapy.
        We are also doing some imaging work following patients
    prospectively over time to see some of the structural and
    functional changes in the brain that occur well after the
    injury.
        Senator Gillibrand. Yes. I have seen those images. They are
    remarkable.
        Dr. Dodick. They are startling.
        Senator Gillibrand. They do some of it locally, I think at
    Walter Reed.
        Dr. Dodick. Yes. So I think there really needs to be a
    public awareness campaign. We have seen the results of massive
    public awareness campaigns where individuals are educated about
    the signs and symptoms of stroke, for example, because now we
    have all these clot-busting therapies, and we need patients to
    recognize them and get into the hospital as quickly as
    possible.
        We need the same sort of public awareness campaign around
    concussion. As I said, 20 million women have suffered traumatic
    brain injury. Forty-six million kids exposed are in contact
    sport.
        It is a massive public health problem, and we need a public
    awareness campaign that matches the importance of this problem.
        Senator Gillibrand. I agree, which is why I think if we can
    have the military be state-of-the-art, we can then have a
    better conversation about sports and particularly kids in
    sports.
        I mean, I do not want my child playing football. It would
    scare the heck out of me. Even soccer scares the heck out of
    me. I was glad when they finally said no headers until you are
    at least, I think, 13 or 14.
        But these are real issues, and I think if the military
    figures it out, then the rest of us can figure it out. That is
    why it is so important.
        A second question. Based on your expertise and research
    into the diagnosis and treatment of TBI in the civilian
    population, what do you think the military and the VA can do to
    improve their approaches to prevention, diagnosis, and
    treatment? What ways can you guys influence the civilian world?
        Dr. Dodick. I will start by just saying that I can only
    talk about what I can control in my own center, and in that
    control, we have implemented what we believe is an evidence-
    based objective and quantitative neurological assessment
    preseason--I am talking about sport athletes now--preseason and
    after injury.
        That is why I said earlier I think it is really important
    that we at least use the tools that we have. While not perfect,
    they are objective, they are quantitative, and they are
    sensitive for detecting concussion.
        So I think an evidence-based approach needs to be
    implemented. This field is evolving. Every day, new research
    comes out. It is incumbent upon us, on behalf of our patients,
    to be able to adapt and evolve with the changing science.
        Senator Gillibrand. Do you think that the military and VA's
    approaches to diagnosis and treatment are effective methods for
    preventing the potential long-term consequences of injury?
        Dr. Dodick. I am not intimately familiar with the military
    concussion protocol. But again, I would just say that, as
    science becomes available, I think that military physicians,
    civilian physicians, we all need to adapt and evolve with that.
        Dr. Devick. I think that there are new things available all
    the time. One of the things is the oculomotor aspect that the
    military hasn't used much so far, but is being used in branches
    of the military, and, of course, balance and cognition are
    being used.
        So I think that package of three evaluating tools is
    becoming more and more the state-of-the-art, at least in
    sports.
        Senator Gillibrand. Thank you.
        Dr. Dodick. It really needs to be objective and
    quantitative, because I have been examining patients for over
    25 years, and even to this day, when an individual comes in
    with a concussive brain injury, I would have a hard time
    picking up, on a bedside neurological examination, deficits
    that I could hang my hat on and say, ``Yes, this individual has
    a brain injury.''
        That is why I think the guesswork needs to be taken out of
    it. The subjectivity needs to be taken out of it. We have
    quantitative, objective tools. We need to implement them now.
    We need to continue the research and work hard to find better
    tools.
        Senator Gillibrand. Thank you.
        Thank you, Mr. Chairman.
        Senator Tillis. Senator Warren, before I recognize you, I
    want to thank you for your consistent participation in these
    subcommittee hearings. This is a very important one. I
    appreciate you being here.
        Senator Warren. Thank you. I apologize for running in. I am
    trying to cover another hearing at the same time.
        Senator Tillis. I should also say there are a number of
    hearings happening at the same time. This is a very important
    subject.
        Senator Warren. But this is really important, and I really
    do appreciate your holding this hearing, Mr. Chairman. This is
    critical.
        I thank all of you for being here today.
        Since 2000, more than 370,000 servicemembers have received
    a first-time diagnosis of traumatic brain injury. It is one of
    the most common and least understood injuries that
    servicemembers experience.
        Thanks to the work that you and others have done, we now
    understand that exposure to blast pressure can result in an
    impact-related concussion where the brain is damaged because it
    bangs around inside the skull.
        But we are also now coming to understand that the blast
    pressure wave can also cause harm by damaging the brain at the
    subcellular level. While most people think of TBI as being the
    result of exposure to an IED explosion on the battlefield, we
    are now learning that it is not the only or even the most
    common source of blast exposure for servicemembers.
        So I was very glad to get an amendment into this year's
    defense bill that requires the Pentagon to begin a longitudinal
    study of the blast exposure that our servicemembers experience
    on the battlefield and when firing larger weapons during
    training.
        Can I just ask you, Dr. Dodick, can you explain why
    tracking blast exposure over time is essential to helping us
    get a handle on this problem?
        Dr. Dodick. I think a blast exposure traumatic brain injury
    is in some ways different than the kind of brain injury that
    one might experience on a football field or on an ice hockey
    rink. There is an acoustic wave, as I mentioned earlier, that
    travels through the brain at very high velocity that, at a
    microstructural level, damages the tissues and disrupts the
    connections between cells, in addition to, as you say, rattling
    the brain around inside its skull.
        So there are multiple mechanisms of injury that I think are
    distinct and unique. I know that there are some research labs
    in the country looking specifically at the cellular level, at
    the injury cascades that are set in motion after an acoustic
    blast like that.
        So I do think the injury is different, and I think the work
    is ongoing right now to see whether or not, at the end of the
    day, does it really matter? Are the same cascades still set in
    motion? Is the initial impact injury from a blunt force to the
    head versus a blast injury, is that the same? How different are
    they?
        There is no question in my mind, as you allude to, that--
    up until recently, we have always said concussion is a
    functional brain injury from which 90 percent of individuals
    recover fully. That may not be the case, because even when you
    do an MRI scan, which is certainly more sophisticated and can
    see the brain at a finer detail than a CT scan, you may not see
    the injury until you peer at a microscopic level with special
    types of MRIs. Then you see these fiber tracks that are just
    completely disrupted, like you took a pair scissors to them,
    that you do not see on a routine MRI scan.
        So I agree with you completely. There is a lot happening at
    a cellular level, at a microstructural level, that we cannot
    pick up on routine clinical imaging. We definitely need more
    imaging research, and we definitely need more basic research to
    understand whether or not these two injuries, the blunt force
    versus the acoustic blast, is similar in the damage to the
    brain that occurs as a result of them.
        Senator Warren. That is very helpful, and it looks like we
    are going to get this one passed into law.
        I also want to note that my amendment requires that the
    Pentagon consider the feasibility of a blast exposure log,
    analogous to a servicemember's jump log for airborne
    operations.
        So let me ask about that one. Could data collection like
    this help ensure that blast exposure is fully documented, so
    that servicemembers get appropriate care if they later develop
    post-concussive symptoms?
        Dr. Miles, could I ask you to weigh in on that?
        Dr. Miles. Certainly. I think that the idea behind that
    helmet sensor and mouthpiece sensor data that we are
    researching is to determine if we can get a sense of how many
    blows and at what force those blows are occurring, that same
    technology could certainly be applied to our servicemembers.
        Dr. Dodick had mentioned earlier the cumulative effect of
    subconcussive blows. That same effect, whether that is because
    of blast injuries from using firearms or explosions in the
    field, although subconcussive at that time, when added up, can
    lead to these same symptoms.
        I think the idea behind keeping track of the amount of
    force that the brain sees over a given time is a very good
    concept and may lead to a threshold identified that, when a
    servicemember reaches that, you pull them out of their activity
    or whatever they are doing that is leading to those exposures.
        Senator Warren. Thank you, Dr. Miles. That is a powerfully
    important point. We all know that traumatic brain injury can
    have devastating, lifelong consequences for our servicemembers
    and our veterans, and I am grateful for the work you are doing
    in this area. I hope you will let us know if there is more we
    can do.
        I have a question about protective equipment, but I am
    already over my time.
        Is that all right, Mr. Chairman? Is that all right?
        Senator Tillis. That is fine.
        Senator Warren. Thank you. Good.
        So I want to go to another area here. The Pentagon is at
    the forefront of research into equipment that protects the
    lives of our soldiers and sailors and airmen and marines. For
    example, I am very proud of the cutting-edge research that the
    Army Natick Soldier Systems Center in Massachusetts is doing,
    everything from improving body armor to preventing stress
    injuries.
        Natick is also at the cutting edge of helmet technology,
    and the research has shown that different helmet designs and
    shapes can change the way that blast pressure impacts the
    brain. But right now, most of the military helmets that we give
    to deploying soldiers are designed principally just to protect
    against bullets and other blunt injuries rather than blast
    injuries.
        So Dr. Miles or Dr. Dodick, whoever would like to do this,
    what does the research tell us about the types of helmet
    modifications that might reduce pressure transmitted to the
    brain in a blast? Who would like to go?
        Dr. Miles?
        Dr. Miles. So I can speak to that in a hockey helmet and
    football helmet. I cannot speak to it in the military helmet.
    So if that is okay?
        Senator Warren. Let me just ask, Dr. Dodick, would you like
    to speak to it in the military context?
        Dr. Dodick. I do not know a lot about the actual helmet
    design that is being developed to prevent that acoustic wave or
    those pressure waves coming from a blast injury, so I am not
    familiar with that technology.
        Senator Warren. But I take it what you would tell me, Dr.
    Miles, let's just do this one in a short summary, is that
    helmet design may have a powerful impact, and this is something
    you think might be worth studying in greater detail?
        Dr. Miles. I think you said that very well. It may have an
    impact. There is a lot of discussion on whether or not football
    helmets are able to be designed to decrease concussive risk.
    Again, the injuries may not be the same, but it seems like a
    very important area of research for the military.
        If that can be designed, and we can reduce the forces that
    the brain is seeing inside the skull, there is a great
    likelihood that you will----
        Dr. Dodick. I would say, Senator Warren, that there is no
    evidence to date that any technology, helmet or otherwise, has
    actually been able to reduce the incidence of concussion,
    because as you said very early on, it is that movement of the
    brain within the skull.
        I make the analogy that it is like an egg. It is like a
    yolk inside of an egg. You shake it and you can break the yolk,
    but the egg looks fine.
        Helmets have done a very good job at preventing skull
    fractures and preventing major, catastrophic intracranial
    bleeding, for example, but there is no evidence yet that they
    have been able to reduce the incidence of concussion.
        Senator Warren. My view on this is that we owe it to our
    servicemembers, anyone who is put in harm's way, to have the
    best possible equipment and the best possible equipment starts
    with research to figure out what works and what doesn't work.
    So I hope this is an area where we are doing more in trying to
    determine what we can do to best protect those who are in the
    field fighting for us.
        Thank you, Mr. Chairman. I appreciate, again, your having
    this hearing.
        Senator Tillis. Thank you, Senator Warren.
        Dr. Miles, I am not going to ask other questions except to
    request that our offices get together to talk about the
    consortium and see what we can do to try and help, because that
    really is a collaboration where it is not just DOD, it is
    private sector, everybody coming together. I think that
    holistic approach is probably going to produce the best result.
        Thank you all for being here. We appreciate your time.
        We can have just a brief transition. We will bring up the
    second panel and a brief introduction and get to opening
    statements.
        Thank you all, and in the interest of time, I am going to
    go ahead and do a brief introduction and get right to the
    opening statements. I want to welcome the second panel: Captain
    and Dr. Michael Colston, director of military health policy and
    oversight for the Assistant Secretary of Defense for Health
    Affairs, Department of Defense; Dr. Joel Scholten, associate
    chief of staff for rehabilitation services for the Veterans
    Affairs Medical Center,
        Washington, D.C.; and David Cifu, senior TBI specialist and
    principal investigator, Chronic Effects of Neurotrauma
    Consortium, Department of Veteran Affairs.
        Welcome all to the committee, and we will do a windshield
    wiper. We will start from the right and go to the left this
    time.

       STATEMENT OF CAPTAIN MICHAEL J. COLSTON, M.D., U.S. NAVY,
        DIRECTOR, MILITARY HEALTH POLICY AND OVERSIGHT FOR THE
           ASSISTANT SECRETARY OF DEFENSE FOR HEALTH AFFAIRS

        Captain Colston. Chairman Tillis, Ranking Member
    Gillibrand, members of the subcommittee, thank you for the
    opportunity to discuss the Department of Defense's efforts
    regarding traumatic brain injury.
        I am honored to testify alongside my esteemed VA
    colleagues. I would also like to thank you for your sustained
    leadership in support of our Nation's servicemembers, families,
    and veterans, especially those dealing with complex issues
    around TBI.
        The Department's approach to evaluation and treatment of
    TBI at the point of injury facilitates rapid identification and
    recovery, reducing the chance of another concussion before a
    servicemember has healed from a first. DOD's mandatory
    screening program promotes early identification of
    servicemembers with concussion, ensuring effective treatment of
    physical, cognitive, and emotional effects of the injury.
        We know that after a brief period of rest, a concussed
    individual can begin a progressive return to activity. The vast
    majority of individuals who sustain a concussion improve
    clinically and do not have any sequelae. On the other hand, we
    see patients who continue to suffer.
        In my practice as a psychiatrist, I have seen a number of
    TBI patients with comorbidities, such as adjustment disorders,
    pain, anxiety, depression, PTSD, and substance use disorders.
        So in short, we find that TBI is a protean disorder that
    can present with a wide range of cognitive, behavioral, and
    physical deficits.
        But we need to meet patients where they are on the road to
    recovery. So DOD remains focused on hard problems around
    diagnostic clarification, because we need to get return-to-duty
    determinations, administrative dispositions, and medical
    disability findings right.
        DOD conducts state-of-the-science research as part of the
    National Research Action Plan, which coordinates our research
    priorities with the VA and NIH [National Institutes of Health].
    DOD also collaborates in the national effort to characterize
    degenerative conditions stemming from subconcussive events or
    blast exposures. The Army STARRS [Study to Assess Risk &
    Resilience in Servicemembers] study is characterizing TBI's
    possible contribution to our suicide problem. Interaction
    between mental health and TBI research portfolios lets us know
    what we know so we can rehabilitate more servicemembers who
    present with complex symptoms.
        As we look to the future of TBI research, we appreciate
    that the human brain represents the most complex organization
    of living structures in all of biology.
        Our investments will pay returns. With your continued
    support, I am confident that our research discoveries, clinical
    innovations, and focus on readiness will bear fruit.
        I look forward to answering your questions.
        [The prepared statement of Captain Colston follows:]

                Prepared Statement by Captain Mike Colston, M.D.
        Chairman Tillis, Ranking Member Gillibrand and members of the
    Subcommittee--thank you for the opportunity to discuss the Department
    of Defense's efforts regarding traumatic brain injury (TBI). I am
    honored to testify alongside my esteemed colleagues from the Department
    of Veterans Affairs. I would also like to thank you for your sustained
    leadership and support of our nation's servicemembers, veterans and
    their families, and especially those dealing with complex issues
    related to TBI. Your investments in TBI research have led to important
    advances in care and a greater understanding of where future research
    should be targeted.
        The Military Health System's overriding mission, centered on
    readiness, is to ensure a medically ready force and this includes our
    management of the TBI Pathway of Care within the Department. Since
    2000, more than 370,000 servicemembers were diagnosed with at least one
    TBI, of which more than 80 percent of those were mild TBI, also known
    as concussion. The vast majority of TBI's are diagnosed in non-deployed
    settings and are caused by training incidents, motor vehicle crashes,
    and falls. Concussions, which often lack obvious visible injury, have
    potential to impact the readiness of the force, which is why the
    Department continues to emphasize and focus on advances in concussion
    diagnostic testing and evaluation, treatment, and research.
                     tbi diagnostic testing and evaluation
        The Department's approach to evaluation and treatment of TBI at the
    point of injury promotes servicemember's health by facilitating rapid
    identification and recovery, reducing the chance of another concussion
    before the servicemember has healed from the first one, and decreasing
    secondary injury. DOD's mandatory screening programs, outlined in
    policy, promote early identification of servicemembers with concussion
    to ensure effective treatment for the physical, cognitive, and
    emotional effects of the injury. Medical screening, triggered by
    servicemembers involved in a potentially concussive event; leads to
    medical evaluation. Examples of potentially concussive events include
    being within 50 meters of a blast event, being in a vehicle associated
    with a blast event, collision or rollover, sustaining a direct blow to
    the head, repeated blast exposures or any instance where an event leads
    to an evaluation directed by a commander.
        The Department is aggressively leveraging new and emerging research
    to better identify servicemembers with a suspected head injury and
    identify servicemembers who are unlikely to recover in the anticipated
    timeframe of a few days to weeks. In addition, the Department is
    actively pursuing new technologies that can detect intracranial mass
    lesions, abnormal cerebral physiology, and other signs of brain injury,
    to objectively inform point-of-injury care for these servicemembers.
    Technology is being developed and some assessment tools have been FDA-
    cleared for combat medics and corpsmen that will enable them to make
    the best clinical decisions for injured servicemembers, allowing them
    to diagnose, assess and treat servicemembers closer to the point of
    injury and to provide prolonged field care in an austere environment.
    These include portable devices to measure brainwave patterns,
    physiological determinants, autonomic dysfunction, environmental
    sensors and portable neurocognitive assessment tools.
                                 tbi treatment
        We know that, after a brief period of rest, a concussed individual
    can begin a gradual and progressive return to pre-injury activity. The
    vast majority of individuals who sustain a concussion improve
    clinically. Due to rapid natural recovery seen after injury and no FDA-
    approved pharmacotherapy for mild TBI, medication use for acute
    concussion is based on management of symptoms. Emerging technology may
    begin to provide insight into treatment response. The Department
    continues to aggressively pursue advances in TBI treatment, allowing
    servicemembers to return to the battlefield, and importantly, to lead
    rich, fulfilling lives post-injury. Novel interventions for symptomatic
    mild TBI are under study and selectively used in some of our intensive
    outpatient programs, including neurofeedback, biofeedback, computer-
    based cognitive rehabilitation, transcranial magnetic stimulation, and
    non-invasive electrical stimulation devices.
                                  tbi research
        The DOD designed and cultivated a gap-driven TBI research portfolio
    that includes a full spectrum of knowledge and materiel solutions
    covering prevention, diagnosis and treatment, and long-term studies
    capturing the natural progression of TBI.
        Priority areas for research include precise TBI classification,
    biomarkers, improving diagnostic capabilities from the point of injury
    to the post-acute period, symptom presentation and treatment response
    to novel treatments, long-term effects of TBI and understanding sex
    differences in TBI. The Department is studying innovative technologies
    such as portable devices to measure the brain's electrical activity,
    environmental sensors, portable neurocognitive assessment tools and
    other concussion evaluation systems.
        The Department has sustained efforts to track the long-term effects
    of TBI. At the request of Congress, several large, longitudinal
    research programs are underway including the ``15-Year Longitudinal
    Studies'' to understand the long-term effects of TBI on servicemembers
    and veterans and the needs of injured servicemembers' caregivers. Some
    of the findings highlight the need to reduce fractured health care
    delivery and to promote the utilization of existing programs that
    support caregivers. The second, ``Improved Understanding of Medical and
    Psychological Needs in Veterans and Servicemembers with Chronic
    Traumatic Brain Injury,'' or ``IMAP,'' make it clear that
    comorbidities, such as PTSD, acute stress, and sleep disruption,
    complicate TBI recovery and create a need for a complementary suite of
    mental health and rehabilitation services for effective TBI treatment.
        The Department is conducting state-of-the-science research as part
    of the National Research Action Plan, which coordinates execution of
    research priorities with other Federal agencies including the
    Department of Veterans Affairs and the National Institutes of Health
    (NIH). One of several large-scale portfolios researching the
    relationship between TBI and neurodegenerative conditions is the
    Chronic Effects of Neurotrauma Consortium (CENC), a DOD and VA
    collaboration exploring the long-term effects of combat-acquired mild
    TBI. Additionally, the DOD-National Collegiate Athletic Association
    Grand Alliance targets collegiate athletes, including those at the
    military service academies, and leverages critical academic
    partnerships to more rapidly amass information on acute concussion
    assessment and return to activity strategies.
        To support the coordinated collection of large data sets across the
    entire TBI research field, DOD and NIH developed and maintain the
    Federal Interagency Traumatic Brain Injury Research (FITBIR)
    informatics system to enhance the speed of knowledge translation to
    best clinical practices.
                        issues affecting future policies
        DOD is focused on the hard problems of comorbidity and diagnostic
    clarification, because these issues inform return-to-duty
    determinations, administrative dispositions including misconduct
    proceedings or separations, and medical disability findings downstream.
    We have found that TBI is a complex disorder that can present with a
    wide range of cognitive, behavioral and physical deficits.
    Epidemiological studies inside and outside of the TBI portfolio are
    ascertaining why TBI often presents with duty-limiting conditions such
    as PTSD, depression, substance use disorders, chronic pain and suicide
    risk.
        We are beginning to understand social determinants and outcomes in
    TBI. We know that functional deficits and impaired psychological health
    interact to influence employment instability in the years after TBI.
    Disruption in activity can lead to lower satisfaction. The Army Study
    to Address Risk and Resilience in Soldiers is characterizing TBI's
    possible contribution to our suicide problem. Interaction between
    mental health and TBI research portfolios helps us to ``know what we
    know,'' so we can rehabilitate more servicemembers who present with
    complex symptomatology and, just as important, tailor policy toward
    appropriate and humane dispositions of servicemembers with TBI.
                            way ahead and conclusion
        As we look to the future of TBI research, we wholly appreciate that
    the human brain represents the most complex organization of living
    structure in all of biology. I was struck, during my four years of
    service on the NIH advisory council for the National Institute of
    Neurological Disorders and Stroke, how wide-ranging and organized the
    national brain research portfolio is, with superb differentiation of
    expertise and research scope between agencies. This investment will pay
    returns.
        The current state of MHS [Military Health System] TBI care is
    supported by a robust pathway of care that leverages a network of
    advanced TBI centers with coordination by the Defense and Veterans
    Brain Injury Center. Synchronization of evaluations, treatments and
    outcomes provides opportunities for rapid translation of research
    findings to enhance clinical care. With your continued support, I am
    confident that our research discoveries, clinical innovations and
    relentless focus on readiness will continue to bear fruit in the years
    ahead. I look forward to answering your questions.

        Senator Tillis. Thank you.
        Dr. Cifu?
        Dr. Cifu. I defer to my colleague, Dr. Scholten.

     STATEMENT OF JOEL D. SCHOLTEN, M.D., ASSOCIATE CHIEF OF STAFF
     FOR REHABILITATION SERVICES FOR THE VETERANS AFFAIRS MEDICAL
     CENTER, WASHINGTON, D.C., ACCOMPANIED BY DAVID X. CIFU, M.D.,
        PRINCIPAL INVESTIGATOR, CHRONIC EFFECTS OF NEUROTRAUMA
               CONSORTIUM, DEPARTMENT OF VETERAN AFFAIRS

        Dr. Scholten. Good morning Chairman Tillis, Ranking Member
    Gillibrand, and members of the subcommittee. Thank you for the
    opportunity to discuss traumatic brain injuries, or TBI.
        I am accompanied today by Dr. David Cifu, my colleague who
    is the senior TBI specialist for VHA [The Veterans Health
    Administration].
        VA's TBI-polytrauma program delivers world-class
    rehabilitation services for veterans and servicemembers.
    Through this program, VA continues to advance the diagnosis,
    evaluation, and treatment of TBI.
        TBI severity is determined at the time of injury and is
    based on the individual's ability to respond to the environment
    and to questioning. The majority of TBI is categorized as mild,
    which is usually more difficult to identify than severe TBI due
    to a lack of visible injury and unspecific symptoms.
        In 2007, VA established a systemwide TBI screening and
    assessment program.
        Senator Tillis. You may need to pull your mike a little bit
    closer. I think they are having a problem recording.
        Dr. Scholten. In 2007, VA established a systemwide TBI
    screening and assessment program. All post-9/11 veterans are
    screened when they access VA for health care. Those who screen
    positive are then evaluated by a TBI specialist.
        Between 2007 and 2017, VA screened over 1.1 million
    veterans and diagnosed over 93,000 of these veterans with a
    history of a mild TBI. These veterans then received an
    individualized rehabilitation plan of care for their specific
    needs.
        Individualized rehabilitation treatment plans are paramount
    to TBI care as these plans consider the impact of symptoms on
    the veteran's unique functional abilities and are developed
    with active input from the veteran and their caregiver to
    develop recovery goals.
        Of the post-9/11 veterans with the TBI diagnosis, over 70
    percent also have a PTSD diagnosis, and over 50 percent have
    both a PTSD and a pain diagnosis. This highlights the
    importance of active integration of mental health and pain care
    providers when treating individuals with TBI.
        The complexity of care needed for veterans with TBI and
    polytrauma is best provided through an integrated medical
    system, such as VA's polytrauma system of care. This system
    includes over 100 facilities that provide specialized
    rehabilitation programs.
        In the field of brain injuries, VA collaborates with
    multiple partners to advance care and research by working
    directly with our veteran service organizations, academic
    partners, the NFL, the NCAA, and Federal agencies such as DOD,
    NIH, and CDC [Center for Disease Control].
        VA and DOD have worked together to develop a common
    definition for TBI. In addition, VA has collaborated with DOD,
    NIH, and academic partners to develop and implement evidence-
    based clinical practice guidelines to help both standardize and
    enhance care.
        VA continues to invest heavily in TBI-related research. In
    fiscal year 2017, VA spent over $35 million in TBI research on
    164 projects, which includes four research centers and VA's
    annual $5 million contribution to the VA-DOD Chronic Effects of
    Neurotrauma Consortium, or CENC. The goal of this research
    consortium is to better understand the lifetime impacts of
    military service, particularly combat-associated concussions
    and their association with mental health disorders, dementia,
    and related neurodegeneration.
        VA's research portfolio, coupled with its integrated TBI
    system of care, provides an optimal setting to better
    understand TBI and translate these findings to enhance clinical
    care.
        Many veteran populations are recognized to be at higher
    risk for suicide, including those living with a history of TBI.
    Because military and veteran suicide rates are elevated
    compared to civilian rates, VA has made suicide prevention a
    top priority. VA offers wide-ranging suicide prevention efforts
    to identify veterans at greatest risk. In July 2017, VA changed
    its policy to allow urgent mental health treatment for veterans
    with an other-than-honorable discharge.
        Mr. Chairman, thank you again for the opportunity to
    testify about the importance of TBI diagnosis, treatment, and
    research. We believe VA is a leader in each of these areas,
    delivering the best care available to our veterans. We welcome
    the opportunity to advance collaboration with our Federal and
    private partners.
        We also thank the subcommittee and Congress as a whole for
    their support in getting our veterans the care they have earned
    and deserve.
        My colleagues and I would be pleased to answer your
    questions. Thank you.
        [The prepared statement of Dr. Scholten follows:]

                    Prepared Statement by Joel Scholten M.D.
        Chairman Tillis, Ranking Member Gillibrand, and Members of the
    subcommittee; thank you for the opportunity to discuss the current
    state of research, diagnosis, and treatment for traumatic brain
    injuries (TBI). I am accompanied by Dr. David Cifu, Senior TBI
    Specialist for the Veterans Health Administration (VHA).
        The Department of Veterans Affairs (VA) TBI/Polytrauma program
    delivers world-class medical and rehabilitation services for veterans
    and servicemembers with TBI and associated polytrauma. Through this
    program, VA continues to advance the diagnosis, evaluation, treatment,
    and understanding of TBI in a variety of ways, including: establishing
    standardized diagnostic and assessment protocols; developing and
    implementing best clinical practices for care; collaborating with
    strategic partners; educating and training in TBI-related care and
    rehabilitation; and conducting, interpreting, and translating research
    findings into improved clinical patient care and caregiver support.
                        definition and diagnosis of tbi
        VA and the Department of Defense (DOD), collaboratively, have
    defined TBI as: a traumatically-induced, structural injury or
    physiological disruption of brain function from an external force as
    indicated by; a loss or alteration of arousal, a loss of memory, an
    alteration of mental state, new neurological deficits or an
    intracranial lesion.
        TBI severity is determined at the time of the injury based on the
    individual's ability to respond to the environment and to questioning.
    The vast majority of TBI is categorized as mild. Mild TBI, which is
    commonly called concussion, is usually more difficult to identify than
    severe TBI, due to the lack of a visible head injury and non-specific
    symptoms, which can also be seen with other diagnoses, such as acute
    stress, depression, and Post Traumatic Stress Disorder (PTSD). The vast
    majority of individuals with mild TBI are symptom-free in two to four
    weeks, but a minority will experience ongoing symptoms, sometimes
    lasting for several months or longer.
        The diagnosis of mild TBI is made historically, determined by the
    individual's loss or alteration of consciousness following the
    traumatic event. Efforts to develop objective measures for a mild TBI
    diagnosis, including advanced imaging and biomarkers, are currently in
    the research phase and not yet useful in the clinical setting.
        VA established a system-wide screening and assessment program in
    2007 to identify veterans with a history of TBI and persistent
    symptoms, so as to provide a definitive diagnosis and allow for the
    development of a treatment plan. This validated screening tool consists
    of questions that VA health care professionals must ask all veterans,
    with a service separation date after September 11, 2001, when they are
    accessed for VA healthcare. Veterans who screen positive are offered
    follow-up evaluations with TBI specialists. Between 2007 and 2017, VA
    has screened over 1.1 million veterans from Operation Enduring Freedom,
    Operation Iraqi Freedom, and Operation New Dawn (OEF/OIF/OND); more
    than 213,000 of these veterans screened positive for possible TBI and
    were referred for a comprehensive TBI evaluation. To date, over 93,000
    of those veterans with a positive screen were diagnosed with having
    sustained a mild TBI, and had an individualized rehabilitation and
    reintegration Treatment Plan of Care developed for their ongoing
    rehabilitation services.
                                   treatment
        Evidence-based treatment following mild TBI is determined by
    symptoms. VA and DOD published Clinical Practice Guidelines in 2009 and
    updated them in 2016 for the management of mild TBI utilizing the
    highest level of medical evidence to guide care (https://
    www.healthquality.va.gov/guidelines/Rehab/mtbi/). Treatment includes a
    combination of therapy, including cognitive, physical, speech, and
    occupational therapy, along with medications to manage specific
    symptoms, such as headaches or anxiety. Individualized rehabilitation
    treatment plans are paramount to TBI care as they consider the impact
    of symptoms on functional abilities with active input from the
    individual and their caregiver to develop recovery goals.
        The complexity of care needed for veterans with TBI and polytrauma
    is best provided through an integrated medical system, as is available
    in VA's Polytrauma System of Care (PSC). Of the new cohort of veterans
    with a TBI diagnosis, over 70 percent also have a PTSD diagnosis, and
    over 50 percent have both PTSD and Pain diagnoses, highlighting the
    importance of active integration of mental health and pain care
    providers in the care for individuals with TBI.
        VA provides the full continuum of care for veterans with TBI of all
    severity through its Polytrauma System of Care, a nationwide
    coordinated system of over 100 facilities providing specialized
    rehabilitation programs. Polytrauma, defined as two or more injuries
    occurring as a result of the same traumatic event that result in
    physical, cognitive, or mental health impairments and functional
    disability, is best served in an integrated medical system. VA's TBI/
    Polytrauma System of Care collaborates with primary care and other
    specialty services, such as mental health, complementary and
    alternative medicine, and vocational rehabilitation, to deliver
    integrated and innovative treatment options that promote veterans'
    choice and support successful community reintegration. VA strives to
    improve access to specialized rehabilitation services and programs for
    veterans with TBI and Polytrauma. These nationwide programs include:

          Transitional Rehabilitation Programs, focusing on
    promoting independence, community reintegration and return to work
    after injury;

          Telehealth services for veterans living at a distance
    from the medical centers;

          Assistive Technology Labs to maximize the functional
    status of veterans with disabilities through the use of adaptive and
    assistive technology;

          Emerging Consciousness Programs serving veterans who are
    slow to recover awareness after severe brain injuries.

        VA also instituted long-term follow-up of veterans with chronic
    problems related to TBI, initially for all those with moderate to
    severe initial injury, and now including those with mild injuries who
    fail to reintegrate successfully into the community. Understanding the
    multifactorial etiologies involved in chronic mild TBI, VA promotes
    health and wellness initiatives, including self-management with mobile
    technologies and collaboration with community partners to offer
    additional services in the areas of fitness and recreational
    activities.
        Military and veteran suicide rates are elevated compared to
    civilian rates and VA has made suicide prevention a top priority. Many
    veteran patient populations are recognized to be at higher risk for
    suicide, including those with psychiatric conditions, and those living
    with a history of TBI. Veterans with mild and moderate to severe TBI
    who sought VA services, died by suicide at 1.8 to 1.3 times the rate of
    all veterans using VA for healthcare. VA offers wide-ranging suicide
    prevention efforts, including the Veterans Crisis Line, suicide
    prevention coordinators, and the rollout of REACHVET, to identify those
    veterans at greatest risk.
                                    research
        VA research related to TBI is wide-ranging and is coordinated under
    the National Research Action Plan (NRAP) in response to Executive Order
    13625, Improving Access to Mental Health Services for veterans,
    servicemembers, and military families. Under the NRAP, VA partners with
    DOD and HHS [Health & Human Services] to coordinate research strategies
    to accelerate discovery and rapidly translate new knowledge into
    diagnostics and treatments of servicemembers and veterans with TBI.
    Among these NRAP-related goals, VA researchers are working: to shed
    light on brain changes in TBI; improve screening methods and refine
    tools for diagnosing TBI; and develop ways to treat brain injury. VA
    researchers are also designing improved methods to assess the
    effectiveness of treatments, and learning the best ways to help family
    members cope with the effects of TBI and support their loved ones. VA
    Research in mild TBI continues to grow. In fiscal year 2017, VA spent
    $35.5 Million in TBI research on 164 projects, including 4 Research
    Centers. Also included in this investment is VA's $5 million per year
    contribution to the NRAP-related VA/DOD Chronic Effects of Neurotrauma
    Consortium (CENC).
        VA has several research centers that are working together to better
    understand TBI and translate findings to enhanced clinical care. These
    include, 1) the Translational
        Research Centers for TBI and Stress Disorders, at the VA Boston
    Healthcare System and at the Michael E. DeBakey VA Medical Center in
    Houston, which study TBI and PTSD, 2) the Brain Rehabilitation Resource
    Center, at the Malcolm Randall VA Medical Center in Gainesville,
    Florida, that seeks to harness neuroplasticity to improve recovery, 3)
    The Research Center for the Prevention and Treatment of Visual Loss at
    the Iowa City VAMC that includes specific research in TBI and vision,
    and 4) The National Center for Rehabilitative Auditory Research at the
    Portland VAMC that includes specific research related to TBI and
    hearing loss.
        As mentioned above VA is part of CENC, which is a coordinated, 30-
    center research collaboration between VA and DOD, centered at the
    Hunter Holmes McGuire VA in Richmond, Virginia. It has been jointly
    funded for $62.2 million since 2013. The focus of CENC is to link
    basic, translational, and clinical neuroscience researchers from VA,
    the military, academia, and the private sector, to effectively address
    the diagnostic and therapeutic ramifications of TBI and its long-term
    effects. CENC's goal is to better understand the lifetime impacts of
    military service, combat-associated concussions (mild TBI), and being a
    veteran, in particular with respect to the development of mental health
    disorders, Alzheimer's, dementia, and related neurodegeneration. Some
    early important findings from CENC include:

          In a cohort of more than 1,100 veterans and
    servicemembers with persistent difficulties after combat concussions
    and related issues, more than two-thirds are high functioning, employed
    and managing well in the community more than seven years after injury.
    The remaining one-third demonstrate ongoing and increasing difficulties
    that require significant health care utilization.

          Servicemembers and veterans with combat-related
    concussions and associated conditions (PTSD, pain, depression,
    substance use, elevated suicide risk) represent a unique and high-risk
    population for long-term difficulties and decline.

          Using big data techniques, among 1.6 million
    servicemembers and veterans, linkages have been identified between
    elevated lifetime risks for neurodegeneration, including Alzheimer's
    dementia, for those with TBI.

        VA tracks TBI rehabilitation outcomes of veterans with TBI and
    compares them to those from the private sector, through collaborative
    research between the five VA Polytrauma Rehabilitation Centers and the
    National Institute of Disability, Independent Living, and
    Rehabilitation Research (NIDILRR) TBI Model Systems' 16-center
    database. Through fiscal year 2017, VA has enrolled over 1,000 veterans
    in the study, generated 24 peer-reviewed scientific publications and
    delivered nearly 90 conference presentations. This Federal interagency
    collaboration enhances VA's ability to define the unique needs of
    veterans following TBI and translate those findings into policy, to
    create continuous quality improvement for TBI rehabilitation within VA.
        Evidence of VA's leadership in TBI research and clinical care has
    been highlighted in several recent special issues of medical journals,
    including: the September 2016 issue of Brain Injury covering results
    from CENC; the October 2017 issue of Brain Injury reporting on outcomes
    from VA's TBI State of The Art Conference;
        and the July 2017 issue of the Journal of Head Trauma
    Rehabilitation showcasing results of VA's involvement in the Federal
    interagency TBI Model Systems program.
        Mr. Chairman, thank you again for the opportunity to testify about
    the importance of TBI diagnosis, treatment, and research. We believe VA
    is a leader in each of these areas, delivering the best care available
    to our veterans, and we welcome the opportunity to advance
    collaboration with our Federal and private partners. We also thank the
    subcommittee and Congress as a whole for their support of getting our
    veterans the care they have earned and deserve. My colleagues and I
    would be pleased to answer your questions.

        Senator Tillis. Dr. Cifu?
        Dr. Cifu. I actually would be open to just answering any
    questions.
        Senator Tillis. You are just here to provide all the
    answers?
        Dr. Cifu. Yes, in the interest of time, sir.
        Senator Tillis. Thank you all for being here.
        I want to jump to something. Dr. Colston, we now are going
    to implement an electronic medical record (EMR) in the VA that
    is a platform that has already been implemented in the DOD. So
    I am trying to think and I want to talk a little bit in two
    different buckets.
        One is the concern that I have with people who have
    received other-than-honorable discharge and I am glad to hear
    from Dr. Scholten that we are helping with crisis intervention
    with persons with other-than-honorable discharge. I think that
    that is good.
        But it seems to me that, on the one hand, looking forward,
    if we do a better job of whether it is their MOS [Military
    Occupational Specialty], the role that they are playing when
    they are deployed where we know that they are going to be
    exposed to events that could potentially have this cumulative
    impact that Senator Warren pointed out, it would seem like we
    should really think through, maybe not in phase one of the EMR
    but in subsequent phases, how we capture some of these life
    events so that we can cumulatively look back and have a high
    degree of certainty that this person may be suffering from TBI.
        Does that make sense to you?
        Captain Colston. Absolutely, sir, and I couldn't agree
    more. If I can relay a story, 30 years ago, I was a nuclear
    engineer on USS Carl Vinson. I wore a dosimeter, and every
    month in my medical record the amount of radiation that I got
    was put in my medical record. That reactor on Carl Vinson could
    have killed me inside of a second, but between occupational
    protections that I had, medical protections that I had, we
    reduced the risk to zero.
        Now, TBI is a much harder problem. The brain is a
    considerably more complex organism than just the body as a
    whole. Blast physics presents a number of challenges.
        I know when Senator Warren spoke there, we are working on
    helmets. We are working on things to maybe get the blast wave
    to go around.
        There are many separate things that happen when you get a
    blast or an impact, and it is really hard to document those
    things. It is a very hard thing to ascertain. So I think, for
    right now, it is very important to get good histories. That is
    where our corpsmen and medics come in with our concussion
    evaluations that discuss what the circumstances were.
        We also have an obligation as clinicians to get really good
    histories and document exposures. I am heartened that the VA is
    going to have the same medical record as us, because I have
    worked in both systems, and I can say it has been very hard
    over the years to kind of figure out what is going on, or the
    delay has been inordinate.
        So I am excited that that is where we are going moving
    forward.
        Senator Tillis. To any of the panelists, I think it was Dr.
    Dodick that said even if you do not have a prior image that it
    was about a 95 percent confidence interval in being able to
    look at a brain image and reasonably determine that they had
    suffered some sort of a concussive trauma.
        Is that possibly something we should look at as a way to go
    back to some members who have been other-than-honorably
    discharged and say maybe there was something there that we did
    not take into account?
        Dr. Scholten. I believe that the evidence may not be there
    to support that type of implementation at this time. I think
    the approach right now is to have a no-wrong-door approach for
    veterans or servicemembers with an other-than-honorable
    discharge.
        With implementation of that policy for those individuals
    who can access for urgent mental health needs, during that
    time, that episode of care can last up to 90 days, during which
    time we can investigate the background, their clinical
    presentation, and determine possibly if their benefit profile
    should be changed.
        Dr. Cifu. In addition to that, as part of the Chronic
    Effects of Neurotrauma Consortium, the large VA-DOD study, we
    are looking at exactly this issue of dose effect from brain
    injury. We have a validated measure to figure out, did they
    have prior concussions?
        Actually, the biggest challenge we have is to find veterans
    and servicemembers who have not had a prior concussion in their
    records. That is the hardest challenge. But we have a validated
    metric.
        So we are recording that, and it is published, and it is
    standardized. But we are recording that as well as monitoring
    serial MRI scans, eye-tracking scans, all the things the prior
    panel talked about.
        What we are trying to do is actually get the knowledge so
    that, if we had that information, we could actually act on it.
    Because it is scary to know that you have had this dose effect,
    whether it is from radiation or from brain injuries. What is
    even more scary is if your clinicians have no clue what to do
    with it.
        What we are trying to do is, instead of just thinking we
    know what to do with it, we are trying to really put some data
    around that so we are on top of it.
        We hope next time we are able to report in front of you, we
    will be able to give you hard evidence on that.
        Senator Tillis. Thank you.
        Senator Gillibrand?
        Senator Gillibrand. Thank you for being here.
        What is the military doing overall to ensure that it will
    do a better job in assessing program effectiveness on more
    evidence-based practices, providing appropriate training to
    providers, and collaborating across the services? Because the
    October report from the Secretary of Defense evaluating
    specific tools, processes, and best practices to improve the
    Armed Forces identification, treatment, and mental health
    conditions in TBI identified six areas to improve service
    provision, including frequent use of evidence-based practices
    and better specialty certification for providers.
        Captain Colston. I can speak to that, ma'am.
        We just spent $50 million from CAPE [The Center for the
    Army Profession and Ethic] to look at programs for
    effectiveness, and I think one of the things that we really
    struggled with was outcomes and fiscal granularity as we looked
    back.
        So going forward, that needs to be a part of the way that
    we do business. So we created a behavioral health data portal
    that, in essence, gets outcomes that are in the medical record
    and will be there for perpetuity.
        We also need to make good choices with regard to programs.
    We need to have a stop-doing list. So if a program is not
    effective, it needs to come off, because it is presenting an
    opportunity cost, and that is something that we definitely need
    to focus on going forward.
        Senator Gillibrand. So I did not feel like you answered
    Senator Tillis' question fully in the last question, because he
    is really saying, what are you doing to create an opportunity
    for someone who may well have been discharged dishonorably
    because of behavior that is absolutely against the rules but
    that would have been caused by traumatic brain injury or PTSD?
        So, specifically, can you address that? What are you doing
    to protect those servicemembers who may well have been punished
    for inappropriate behavior that was actually caused by these
    diseases?
        Captain Colston. Yes, ma'am.
        First, there are opportunities for reclama, so there are
    boards of correction for military records.
        The second thing that we implemented was an across-the-
    board look at people who had medical boards stopped for one
    reason or another, say for disciplinary reasons. We had a
    Physical Disability Board of Review actually look at those, and
    opposed to like a BCMR [Board of Correction for Military
    Records] where maybe 5 percent of cases get recharacterized,
    that board was around 30 percent.
        We also wrote special guidance for the boards of correction
    for military records, secondary to some of Senator Blumenthal's
    efforts, for Vietnam vets and other folks who may have had
    illnesses before we even had the capability to recognize this.
        Really, the first good literature about PTSD and TBI and
    really good literature about post-concussive symptoms and
    mental health systems that were sustained well beyond having
    those two things together was an epidemiological study by Lisa
    Brenner in 2010 at the MIRECC [Mental Illness Research,
    Education, and Clinical Center] in Denver, one of my VA
    colleagues.
        So the science is still nascent, but we really need to
    protect folks.
        I think that we have tried to get ahead of the problem in a
    lot of ways. So now before we administratively separate
    someone, we do an evaluation for PTSD and TBI.
        When I was a resident at Walter Reed in 2000, we would
    administratively separate people from the emergency room. In
    fact, we had about 4,000 administrative separations for mental
    health issues a year. We have reduced that to 300 now. So that
    was a round turn. That happened really quickly in the late
    2000s.
        Senator Gillibrand. Great. Related, many survivors of
    military sexual trauma suffer from PTSD as a result of that
    trauma. What is the military doing to diagnose and treat PTSD
    that results from military sexual trauma? Is their diagnosis
    and treatment different from the diagnosis and treatment for
    PTSD caused by a blast injury or other combat activity where
    there might be a co-occurring brain injury?
        Captain Colston. Absolutely. I think that Edna Foa's group
    at the University of Pennsylvania, I think CPT [Cognitive
    Processing Therapy] and prolonged exposures, those are both
    very good treatments for military sexual trauma.
        I think one of the things that I have noticed as a
    psychiatrist is you can take a person who really did not have a
    lot of premorbid illness, who did not have adverse childhood
    experiences, they can be sexually assaulted, and they can just
    break apart. So as leaders, it is really incumbent upon us to
    set up a system where we are vigilant for those types of
    injuries.
        The incidence of sexual harassment and abuse in this Nation
    is horrible, and in the cohort of patients that I treat, of
    course, it is much higher.
        So we need to be really focused on access to care for that
    group, meeting patients where they are, and the ability of
    confidential care.
        For instance, a servicemember can actually walk into a VA
    vet center and get treatment for military sexual trauma. But as
    a clinician who is actually writing things in the record, I
    also need to be sensitive to that patient's needs. I do not
    need to be writing details about what is going on, nor do I
    have to have a close contact with command. I need to be focused
    on that patient's needs and making that patient better.
        Senator Gillibrand. I appreciate that.
        Can I ask a follow-up?
        Senator Tillis. Sure.
        Senator Gillibrand. So to Dr. Scholten and Dr. Cifu, please
    describe the VA programs that have been developed to diagnose
    and treat military sexual trauma-induced PTSD in veterans
    seeking treatment for TBI. Are we doing enough?
        Dr. Scholten. Thank you for that question.
        So VA has an extensive military sexual trauma program and
    implementation of screening at all VA medical centers. We
    screen every veteran accessing VA for care for military sexual
    trauma. Actually, the screening rate was 98.7 percent in fiscal
    year 2016.
        Senator Gillibrand. Can you do it from the other end? If
    someone comes in for PTSD, do you check that it might be not a
    blast but actually trauma? Meaning, they do not come in for
    sexual trauma; they come in for PTSD.
        Dr. Scholten. Exactly. Right. That is a good point, because
    military sexual trauma is not a diagnosis. It is an experience.
    They are screened for the diagnosis as well as the experience,
    and then their individual treatment plan is based upon their
    symptomatology and their presentation.
        In addition, VA has a large research portfolio trying to
    better understand the impact of military sexual trauma and its
    effect on associated mental health conditions.
        Dr. Cifu. Importantly, so if they come in, they get
    screened, for example, for TBI, they are also going to be
    screened for the PTSD diagnosis. That PTSD diagnosis could be
    due to military sexual trauma.
        The beauty of the integration of the VA system across every
    VA is that the team doesn't just treat TBI or PTSD from a blast
    or a depression. The team is set up to treat all the diagnoses
    within the same setting with the same core of providers.
        That is a huge difference. Nobody wants to come back 3 days
    later or go to another setting.
        Senator Gillibrand. Exactly.
        Dr. Cifu. So we are very aware that each patient is unique,
    but we are doing it within the same team context, what used to
    be called a medical home. Primary care is involved, but the
    specialists are too.
        So each diagnosis is vitally important but military sexual
    trauma, it has a uniqueness to it. But that is also handled in
    the same setting, which we think is an advantage across the
    United States.
        Senator Gillibrand. Thank you very much.
        Senator Tillis. Just one final question for Dr. Colston.
        Dr. Colston, when you were describing your experience
    working near a reactor, the beauty of that is you knew where it
    was, and you had precise measurement devices to make sure that
    you were in a safe environment. Is there any work being done
    to, again, look at the MOS or the task?
        Let's say that you are in artillery or you are in various
    conditions where--again, the cumulative impact that we were
    talking about is something that I have not spent a lot of time
    studying, and I will, but any way--where we could reasonably
    predict that some people need to be tested or we have to
    provide research just based on the--until we have helmets that
    can deflect the waves and do the sorts of things to minimize
    the injury, is there any research being done in DOD in that
    light?
        Captain Colston. Yes, sir. In fact, I was speaking with my
    colleague, Dr. Bennett, who is in the audience, at the Office
    of Naval Research yesterday about a lot of the work that is
    being done around blast physics and attempt to ascertain what
    happens with any particular blast.
        You shoot a .50 caliber, that is about a half PSI pressure
    wave. A breacher is seeing maybe 2 PSI. But a breacher may see
    400 or 500 of those. Then, certainly, an IED can be something
    much higher than 10 or 15.
        We are very worried about what we see downstream. Dr. Perl
    at the Uniformed Services University has seen almost a
    pathognomonic lesion associated with blast injury.
        Now, there is a lot of crossover in between lesions that we
    see in the brain, but this particular lesion was at density
    junctions, in other words, right where you would deposit injury
    from a blast wave.
        A blast wave is not just running 25,000 feet a second
    through the brain. There is also a coup-contrecoup injury,
    where your brain is sloshing around in your skull, and,
    obviously, fragments.
        So there is all kinds of work to do in the research realm
    that we are working on assiduously, and we need to do it fast,
    because, certainly, the next battles are out there.
        Senator Tillis. I want to thank all of the panelists from
    the first and second panel for being here. I think this has
    been a very informative hearing, and it is one that we need to
    focus a lot of attention on. I think we have all highlighted
    our concern prospectively for men and women serving in uniform
    but also for the veterans.
        So I thank you all for your testimony and your time here
    today.
        We will hold the committee record open through the end of
    business tomorrow so that you can submit any other information.
    We may also submit some questions for the record, and other
    members will be allowed to do the same.
        Senator Tillis. Thank you all for being here today. Thank
    you for your service to our veterans and our men and women in
    uniform.
        This committee is adjourned.
        [Whereupon, at 11:23 a.m., the subcommittee was adjourned.]

        [Questions for the record with answers supplied follow:]

                   Questions Submitted by Senator Joni Ernst
                                 mental health
        1. Senator Ernst. Captain Colston, will OSD be adopting any new
    policies relating to the mental health counseling profession in time to
    save the jobs of counselors serving as Directors of Psychological
    Health in the Air National Guard who scheduled to lose their positions
    in September 2018?
        Captain Colston. There are no new OSD policies currently being
    considered to address this issue. Department of Defense Instruction
    6025.13, Medical Quality Assurance and Clinical Quality Management in
    the Military Health System, dated February 17, 2011, delegates the
    responsibility for determining privileging standards and requirements
    to the individual Military Departments. The position of Director of
    Psychological Health (DPH) in the Air National Guard's Psychological
    Health Program was determined by the Air Force to require a privileged
    mental health provider. This determination did not result in a
    reduction in positions. However, in response to the conversion from
    contracted to Title 5 civilian positions during fiscal year 2015, it
    was discovered that some currently serving DPHs did not meet the
    requirements to be a privileged mental health provider, per Air Force
    Instruction 44-119. Local commanders were given the choice of offering
    the incumbent DPHs who did not meet privileging requirements a
    temporary 4-year position in a lower grade, or immediately hiring a
    privileged provider. There were 12 DPHs retained in the lower graded
    position, and their terms will expire on September 30th, 2018. DPHs are
    ANGs first line of defense at addressing operational, occupational and
    combat stressors all of which directly impact mission readiness.
    Limited-capability DPHs are not able to conduct needed mental health
    assessments, which could negatively impact the mission. The ANG plans
    to recruit and fill the DPH positions with privileged health care
    providers.
                               special operators
        2. Senator Ernst. Captain Colston, one area of concern for me, for
    our Special Operators in particular, is brain trauma that can only be
    evaluated post-mortem. I recently visited Navy SEALS who are now
    baselining brain conditions prior to combat operations to better
    diagnose unseen injuries throughout a member's lifecycle. Is this an
    approach that should be adopted across the Force?
        Captain Colston. USSOCOM's 70,000 operators likely see the highest
    exposure to precipitants of traumatic brain injury, including blast
    injury, among our servicemembers. For that reason (and in accordance
    with DOD policy) USSOCOM continues its efforts to document baseline
    brain function prior to combat and training exposures. Yet, there is
    currently insufficient evidence to recommend a baseline evaluation of
    brain conditions for all servicemembers. However, the baseline brain
    function data currently being gathered from USSOCOM personnel in
    response to Section 722 of Fiscal Year 2011 NDAA Public Law 111-383
    will prove invaluable to the research efforts in this arena. If the
    future evidence supports the baseline evaluation of brain function in
    Special Operators, expansion of that approach across the force would be
    warranted. Research to date does not support the utility of baselining
    individual function over the use of normative (or pooled) data in the
    clinical realm. This case mirrors other aspects of evidence-based
    patient care, where precision medicine efforts compete with population-
    based approaches on a case by case basis.
                                   __________
                Questions Submitted by Senator Elizabeth Warren
                           medical marijuana research
        3. Senator Warren. Dr. Scholten, Dr. Cifu, Captain Colston, 29
    States and the District of Columbia have laws allowing the prescription
    of medical marijuana, but the Federal Government continues to classify
    marijuana as a Schedule one narcotic. This makes it difficult to
    conduct serious research on the therapeutic benefits of medical
    marijuana--such as the drug's potential as a treatment for PTSD or as
    an alternative pain treatment to prescription opioids. The Federal
    classification of medical marijuana also means that the VA can't
    reimburse vets who use it to treat PTSD or chronic pain. As medical
    professionals, do you believe that we should be making it harder or
    easier to conduct research on potential treatment options for PTSD?
        Dr. Scholten. and Dr. Cifu. VA Response: Marijuana has not been
    found to be safe or effective for therapeutic use for individuals who
    have persistent symptoms resulting from post-traumatic stress disorder
    (PSTD) or mild TBI (concussion), including pain. Given the central
    acting effects (e.g., altered mentation, drowsiness), potential for
    insult to the central nervous system, and the risk of addiction in the
    population of individuals with symptoms and difficulties arising from
    either PTSD or mild TBI, the use of or research into the potential
    therapeutic effects of marijuana must be considered with extreme
    caution. That said, more research is needed in this area. In general,
    clinical trials conducted by the scientific research community will
    inform decisions on whether marijuana is a safe and effective treatment
    agent. It remains critical that drug approvals and policy decisions be
    evidence based. The Controlled Substances Act, the Food, Drug, and
    Cosmetic Act, and other legal frameworks that govern the process for
    undertaking research on marijuana do provide a pathway for that
    research, although Federal Departments continue to explore ways to
    improve the process. DEA's [Drug Enforcement Agency] January 2018
    launch of an online application process for Schedule I researchers is
    one recent result of these efforts.
        Captain Colston. Effective treatments for PTSD remain elusive. Any
    high quality research that could provide better treatment options to
    improve patient care would be welcomed by medical professionals. With
    respect to research involving medical marijuana, there are important
    caveats that must be considered, primarily the principle of non-
    maleficence, or not doing harm to patients or research subjects. Legal
    and logistical issues will continue to complicate research. In order to
    complete rigorous studies, patients need to be recruited from a wide
    demographic base and given treatments that are measurable with respect
    to doses and response. Recruitment is complicated by great variance in
    state laws, limiting feasible research protocols. The recent Justice
    Department decision notwithstanding, disparity across the states in
    laws governing cannabis use will hamper patient recruitment and
    randomization. Further, cannabis readily available to the public, in
    dispensaries and elsewhere, varies widely in potency and psychoactive
    properties. The result is that cohort studies and other population-
    based inferences will continue to have limited utility in answering
    questions about salutary or deleterious effects of marijuana used to
    decrease suffering, and only focused, highly funded multi-site
    protocols will likely be productive. The National Institutes for
    Health, and National Institute for Drug Abuse in particular, have the
    capability to do such studies and the authority to research the medical
    effects of schedule one drugs such as Methylenedioxymethamphetamine and
    marijuana. Researchers there, with whom DOD researchers interact
    regularly, have a wider base of expertise and technical competence to
    answer these important questions, from which DOD could undoubtedly
    benefit.

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