Vietnam Head Injury Study - Phase III

Traumatic Brain Injury Clinical Trial

Official title:

A 40+ Year Post-Injury Follow-Up Study of Vietnam Veterans Who Sustained Traumatic Brain Injury While in Combat.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132249
• Other study ID #: DAMD17-01-1-0675
• Status: Completed
• Start date: April 2004
• Est. completion date: September 2010

Study information

• Verified date: August 2018
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Closed Head Trauma
• Craniocerebral Trauma
• Head Injuries, Closed
• Head Injuries, Penetrating
• Penetrating Head Injury
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	National Naval Medical Center	Bethesda	Maryland

Sponsors (10)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	Cardiff University, George Mason University, Georgetown University, National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health Clinical Center (CC), University of Hertfordshire, University of York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the assessment of a large number of the genetic markers and the relation to various out come measures.		3 years