[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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