Vietnam Head Injury Study - Phase III

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ClinicalTrials.gov Identifier: NCT00132249

Recruitment Status : Completed

First Posted : August 19, 2005

Last Update Posted : August 16, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

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 (Responsible Party):

U.S. Army Medical Research and Development Command

Tracking Information

First Submitted Date

August 17, 2005

First Posted Date

August 19, 2005

Last Update Posted Date

August 16, 2018

Study Start Date

April 2004

Actual Primary Completion Date

September 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

the assessment of a large number of the genetic markers and the relation to various out come measures. [ Time Frame: 3 years ]

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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.

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 Type

Observational

Study Design

Observational Model: Case-Control
Time Perspective: Other

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

199 head-injured subjects attended PH3. 55 control subjects attended PH3.

Condition

Traumatic Brain Injury
Penetrating Head Injury
Closed Head Trauma

Intervention

Not Provided

Study Groups/Cohorts

Head Injured
The Vietnam Head Injured Subjects
Head Uninjured
Uninjured Vietnam Veteran Control Subjects

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Actual Enrollment

254

Original Enrollment

500

Actual Study Completion Date

September 2010

Actual Primary Completion Date

September 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

Sexes Eligible for Study:

Male

Ages

Child, Adult, Older Adult

Accepts Healthy Volunteers

Yes

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

NCT00132249

Other Study ID Numbers

DAMD17-01-1-0675

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Current Responsible Party

U.S. Army Medical Research and Development Command

Original Responsible Party

Not Provided

Current Study Sponsor

U.S. Army Medical Research and Development Command

Original Study Sponsor

Same as current

Collaborators

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

PRS Account

U.S. Army Medical Research and Development Command

Verification Date

August 2018

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