NIH Clinical Research Studies

Protocol Number: 08-N-0198

Active Accrual, Protocols Recruiting New Patients

Title:
Warfighter Head Injury Study - a Comprehensive, Multidisciplinary Research Evaluation
Number:
08-N-0198
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..

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 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 history of head injury. 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):
Traumatic Brain Injury
Head Injury
Healthy Volunteer
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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