Warfighter Head Injury Study

The Warfighter Head Injury Study (WHIS) is a comprehensive, multidisciplinary research study
of head-injured warfighters to be conducted at the National Institutes of Health (NIH) in
Bethesda, Maryland. The goals of the WHIS include providing clinicians and scientists with
new insights into the short term recovery of function following traumatic brain injury (TBI),
the role of the prefrontal cortex (PFC) in executive and social functions, and to identify
better predictors of short term outcome (including cognitive, neurological, and genetic
factors). With the assistance of the Department of Veterans Affairs/Veterans Health
Administration (VA/VHA), we propose to contact all Iraqi-Afghan (IA) warfighters with
penetrating head injury (PHI), a cohort of blast injured warfighters, and a group of matched
(for time in service, combat exposure, age, gender, and preinjury Armed Services Vocational
Aptitude Battery [ASVAB] scores) healthy warfighter controls as well as healthy volunteers
with different blast exposures (i.e.: explosives experts, artillery operators, etc ) but no
documentation of brain injury. We will inquire about their willingness to participate in a
comprehensive, multidisciplinary outpatient evaluation conducted at the NIH. In addition to
IA warfighters, we also plan to enroll Vietnam warfighters who were included in the W. F.
Caveness Vietnam Head Injury Study (VHIS) Registry, in order to conduct detailed comparisons
between groups. These cohorts represent a unique opportunity for study; they were healthy and
employed before injury, preinjury intelligence testing is available, and the VA/VHA permits
long-term follow-up. We have previously investigated Vietnam warfighters with PHI and the
published results of those studies have changed the management and evaluation of head-injured
warfighters, and contributed to knowledge of brain function and the long-term effects of head
injury. Furthermore, based on the knowledge acquired in our previous research with Vietnam
warfighters and our current interests in the functions of the human PFC, cognitive
neuroplasticity in the young brain, posttraumatic stress disorder (PTSD), posttraumatic
epilepsy (PTE), caregiver stress, and genetic-plasticity relationships, we are proposing a
series of new cognitive neuroscience experiments and battery of standardized
neuropsychological testing to be conducted during the WHIS. In this effort, the experimental
testing will be complemented with structural imaging (magnetic resonance imaging [MRI] or
computed tomography [CT]), diffusion tensor and perfusion imaging, electroencephalogram
(EEG), near-infrared spectroscopy (NIRS), and molecular genetics evaluations. This
combination of unique patients, cutting edge cognitive neuroscience experiments and state of
the art techniques will lead to new scientific knowledge and improved clinical management of
warfighters with TBI.

TBI PATIENTS:

We will study up to 320 head-injured IA warfighters (200 PHI and 120 blast injuries), most
of whom have served in Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF),
and up to 500 who have been included in the VHIS Registry. PHI makes up about 20% of the
total TBI from OIF and OEF.

We will ask all WHIS patients to travel to the NIH with their primary caregiver to serve as
their Durable Power of Attorney (DPA) (see Section X for more information on the DPA);
Caregivers will be asked to complete questionnaires and will execute a separate consent
(see Caregiver Consent Form).

Inclusion of active duty military personnel is not essential to this study and can be
completed without them, if necessary.

INCLUSION:

- Both sexes will be included, however we expect the cohort to be overwhelmingly (>90%)
male,

- Age range18-75;

- At least 6 months post-head injury; or

- Those patients who have previously participated in the VHIS.

EXCLUSION:

-Any medical condition that, in the judgment of investigators, would make participation
detrimental to the patient (e.g.: severe clinical depression, unstable heart disease).

CONTROLS:

We will recruit 50 of the VHIS controls, 200 healthy IA warfighter control subjects, with
no history of neurologic or serious psychiatric disorder or any other medical condition
that would pose a risk from participation (e.g., unstable heart disease) and 120 healthy
volunteers with different exposures but no documentation of brain injury. An example of
this latter group would include someone who might be employed as a teacher of the proper
use of explosive devices (i.e. a trainer from the Bureau of Alcohol, Tobacco and Firearms)
and functions well in that position except for an occasional complaint. We will recruit up
to a total of 370 normal volunteers.

We will ask all WHIS controls to travel to the NIH with a companion, some one deemed close
to them in terms of relationship (i.e.spouse, child, etc.), to serve as control
participants for the caregivers of warfighters. Companions will be asked to complete
questionnaires and will execute a separate consent (see Caregiver/Companion Consent Form).

INCLUSION:

- Control subjects will be healthy IA warfighter volunteers who are matched to
head-injured IA warfighters for time in service, combat exposure, age, gender and
preinjury ASVAB scores. All IA warfighter control participants must provide copies of
their ASVAB induction testing scores, if applicable; or

- Individuals who have had different blast exposures (e.g., explosives expert) but no
documentation of brain injury; or

- Those warfighter controls who have previously participated in the VHIS.

EXCLUSION:

- Neurological or psychiatric conditions as mentioned above;

- History of drug abuse; or

- Unable to travel independently.

CAREGIVERS/COMPANIONS:

We will enroll caregivers and companions (i.e.: family members, domestic partners, etc.) of
WHIS Warfighter participants in order to learn more about the potential burden and related
issues experienced by this group.

INCLUSION:

- Provides care to a Warfighter or,

- Chosen by a control participant as a close companion; and

- Their Warfighter provides informed consent and agrees to participate in the WHIS
project.

EXCLUSION:

- Inability to provide informed consent; or

- No working knowledge of the English language.