Warfighter Head Injury Study

NCT00754169 | Terminated

• 2 other identifiers: 08019808-N-0198
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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..

Conditions

Head Injury

Keywords

Traumatic Brain Injury; Brain Imaging; Brain Plasticity; Neuroplasticity; Neuropsychological Testing; Head Injury; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• The effects of focal lesions on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury

Secondary Outcomes (1)

• Genetic influence on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• United States Department of Defense: collaborator
• National Institutes of Health Clinical Center (CC): collaborator
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Abell F, Krams M, Ashburner J, Passingham R, Friston K, Frackowiak R, Happe 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. doi: 10.1097/00001756-199906030-00005.

  PMID: 10501551 BACKGROUND

• Adolphs R. The neurobiology of social cognition. Curr Opin Neurobiol. 2001 Apr;11(2):231-9. doi: 10.1016/s0959-4388(00)00202-6.

  PMID: 11301245 BACKGROUND

• Adolphs R. Cognitive neuroscience of human social behaviour. Nat Rev Neurosci. 2003 Mar;4(3):165-78. doi: 10.1038/nrn1056.

  PMID: 12612630 BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Eric M Wassermann, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 17, 2008
• Study Start: September 5, 2008
• Study Completion: January 9, 2013
• Last Updated: October 6, 2017

Record last verified: 2013-01-09

Locations

US (1)