We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Warfighter Head Injury Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00754169
Recruitment Status : Terminated
First Posted : September 17, 2008
Last Update Posted : October 6, 2017
United States Department of Defense
National Institutes of Health Clinical Center (CC)
Center for Neuroscience and Regenerative Medicine (CNRM)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

This study will examine the long-term outcome of brain injuries, the effects of treatment on outcome and the effects of brain injury on people s behavior and abilities.

Men and women between 18 and 75 years of age who served in combat in the Iraq war may be eligible for this study. It will compare test results in those who sustained a traumatic penetrating or blast-related brain injury during combat with those who did not.

Participants undergo the following procedures over a 5-day period of testing that lasts about 6 hours a day:

  • Medical history and physical examination.
  • Blood test for genetic analysis.
  • Electroencephalography (EEG) to measure the electrical activity of the brain.
  • MRI or CT scans of the brain to look at the structure and blood flow of the brain.
  • Functional near-infrared spectroscopy (fNIRS) to monitor blood flow in the front part of the brain blood by measuring changes in near-infrared light.
  • Neuropsychological testing, including questionnaires, pen-and-paper or computerized tests, and performance of simple actions to measure brain function, language, memory and other cognitive abilities..

Condition or disease
Head Injury

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 314 participants
Time Perspective: Other
Official Title: Warfighter Head Injury Study a Comprehensive, Multidisciplinary Research Evaluation
Study Start Date : September 5, 2008
Study Completion Date : January 9, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Primary Outcome Measures :
  1. The effects of focal lesions on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury

Secondary Outcome Measures :
  1. Genetic influence on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes



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.


  • 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.


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


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).


  • 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.


  • Neurological or psychiatric conditions as mentioned above;
  • History of drug abuse; or
  • Unable to travel independently.


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.


  • 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.


  • Inability to provide informed consent; or
  • No working knowledge of the English language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754169

Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
United States Department of Defense
National Institutes of Health Clinical Center (CC)
Center for Neuroscience and Regenerative Medicine (CNRM)
Layout table for investigator information
Principal Investigator: Eric M Wassermann, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00754169    
Other Study ID Numbers: 080198
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: January 9, 2013
Keywords provided by National Institutes of Health Clinical Center (CC):
Traumatic Brain Injury
Brain Imaging
Brain Plasticity
Neuropsychological Testing
Head Injury
Healthy Volunteer
Additional relevant MeSH terms:
Layout table for MeSH terms
Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases