Vietnam Head Injury Study - Phase III

This study has been completed.

Sponsors and Collaborators:	U.S. Army Medical Research and Materiel Command National Institute of Neurological Disorders and Stroke (NINDS) George Mason University National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institutes of Health Clinical Center (CC) University of York National Institute of Mental Health (NIMH) University of Hertfordshire Georgetown University Cardiff University
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00132249

Purpose

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.

Condition	Phase
Traumatic Brain Injury Penetrating Head Wound Closed Head Trauma	Phase III

MedlinePlus related topics: Injuries Traumatic Brain Injury Wounds

U.S. FDA Resources

Study Type:	Observational
Official Title:	A 30 Year Post-Injury Follow-Up Study of Vietnam Veterans Who Sustained Traumatic Brain Injury While in Combat.

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Enrollment:	254
Study Start Date:	April 2004
Study Completion Date:	September 2007

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

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132249

Locations

United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889

Sponsors and Collaborators

U.S. Army Medical Research and Materiel Command

National Institute of Neurological Disorders and Stroke (NINDS)

George Mason University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institutes of Health Clinical Center (CC)

University of York

National Institute of Mental Health (NIMH)

University of Hertfordshire

Georgetown University

Cardiff University

Investigators

Principal Investigator:	Jordan Grafman, PhD	Cognitive Neuroscience Section, NINDS, NIH
Principal Investigator:	Andres Salazar, MD	NINDS, NIH

More Information

Vietnam Head Injury Study - Phase III Website This link exits the ClinicalTrials.gov site

Cognitive Neuroscience Section Home Page This link exits the ClinicalTrials.gov site

Study ID Numbers:	DAMD17-01-1-0675, NNMC IRB ID# B03-043
Study First Received:	August 17, 2005
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00132249
Health Authority:	United States: Federal Government

Keywords provided by U.S. Army Medical Research and Materiel Command:

Traumatic Brain Injury
Penetrating head wound
Closed head trauma
Vietnam Veteran

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Head Injuries, Closed

Wounds, Nonpenetrating
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009