Vietnam Head Injury Study - Phase III

Completed

• Conditions: Penetrating Head Injury; Closed Head Trauma; Traumatic Brain Injury

• Registration Number: NCT00132249
• Lead Sponsor: U.S. Army Medical Research and Development Command

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-08-17
• Study First Submitted QC: 2005-08-17
• Study First Posted: 2005-08-19
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 254

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the assessment of a large number of the genetic markers and the relation to various out come measures.	3 years

Trial Locations

Locations (1)

National Naval Medical Center; 🇺🇸 Bethesda, Maryland, United States