[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

                               __________

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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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