NIH Clinical Research Studies

Protocol Number: 08-N-0198

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Title:
Warfighter Head Injury Study - a Comprehensive, Multidisciplinary Research Evaluation
Number:
08-N-0198
Summary:
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 Defense (DoD) and the 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 controls. 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, clinical 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.
Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

TBI SUBJECTS:

- Warfighter with documentation of head injury;

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

- Age range18-75;

- At least 6 months post-head injury; or

- Those patients who have previously participated in the VHIS.

CONTROLS:

- Warfighter with NO head injury history. 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

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

- Age 18-75;

- Either gender or any race/ethnicity;

- Able to travel and function independently.

EXCLUSION CRITERIA:

TBI SUBJECTS:

- 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:

- Neurological or psychiatric conditions;

- History of drug abuse; or

- Unable to travel independently.

Special Instructions:
Currently Not Provided
Keywords:
Traumatic Brain Injury
Brain Imaging
Brain Plasticity
Neuroplasticity
Neuropsychological Testing
Recruitment Keyword(s):
None
Condition(s):
Head Injury
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Neurological Disorders and Stroke

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Abell F, Krams M, Ashburner J, Passingham R, Friston K, Frackowiak R, HappŽ F, Frith C, Frith U. The neuroanatomy of autism: a voxel-based whole brain analysis of structural scans. Neuroreport. 1999 Jun 3;10(8):1647-51.

Adolphs R. The neurobiology of social cognition. Curr Opin Neurobiol. 2001 Apr;11(2):231-9. Review.

Adolphs R. Cognitive neuroscience of human social behaviour. Nat Rev Neurosci. 2003 Mar;4(3):165-78. Review.

Active Accrual, Protocols Recruiting New Patients

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