Clinical trial NCT00132249: Vietnam Head Injury Study - Phase III
Official title: A 40+ Year Post-Injury Follow-Up Study of Vietnam Veterans Who Sustained Traumatic Brain Injury While in Combat.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Penetrating Head Injury
Closed Head Trauma
Keywords: Traumatic Brain Injury
Penetrating head wound
Closed head trauma
Vietnam Veteran
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: George Mason University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Institutes of Health Clinical Center (CC)
name: University of York
name: National Institute of Mental Health (NIMH)
name: University of Hertfordshire
name: Georgetown University
name: Cardiff University
First posted: 2005-08-19
Enrollment: 254
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 199 head-injured subjects attended PH3. 55 control subjects attended PH3.

Brief summary: The Vietnam Head Injury Study (VHIS)-Phase III is a prospective, long-term follow-up study of head-injured Vietnam veterans. The purpose of this research study is to determine the long-term consequences, if any, of head injury.

Detailed description: The VHIS - Phase III evaluation to be conducted approximately 30 years post-injury will be devoted to examining, cutting-edge cognitive neuroscience issues and will utilize state of the art technologies to address basic research questions in the following areas: (1) Functions of the human prefrontal cortex; (2) Cognitive neuroplasticity in the aging brain; (3) Memory; (4) Long-term behavioral and psychosocial outcome; and (5) Neurological studies, including an evaluation of post-traumatic epilepsy and repeat clinical measures from Phase - II. This testing will be complemented with structural neuroimaging, electroencephalogram (EEG) and molecular genetics. The goals of the VHIS - Phase III include providing clinicians and scientists new insights into the long term recovery of function following brain injury, the role of the prefrontal cortex in executive functions, better predictors of long term outcome (including cognitive, neurological, and genetic factors), and the effects of head injury incurred in youth on aging and the development of dementia.

Eligibility criteria: The researchers are seeking healthy CONTROL participants.

Inclusion Criteria:

* Vietnam Veteran
* Served in active combat between 1966 - 1971
* Male

Exclusion Criteria:

* Any medical condition that would make participation detrimental to the control (i.e.: severe clinical depression, acute heart dysfunction, etc...)
* A history of severe head injury, stroke, loss of consciousness, or other significant neurological, psychiatric or medical condition that would render the subject unsuitable for the VHIS testing battery.

Primary outcomes:
measure: the assessment of a large number of the genetic markers and the relation to various out come measures.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Naval Medical Center
state: Maryland
Study officials:
affiliation: Cognitive Neuroscience Section, NINDS, NIH
name: Jordan Grafman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NINDS, NIH
name: Andres Salazar, MD
role: PRINCIPAL_INVESTIGATOR
References: