Vietnam Head Injury Study - Phase III

NCT ID: NCT00132249

Last Updated: 2018-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Penetrating Head Injury Closed Head Trauma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Head Injured

The Vietnam Head Injured Subjects

No interventions assigned to this group

Head Uninjured

Uninjured Vietnam Veteran Control Subjects

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

George Mason University

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role collaborator

University of York

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Hertfordshire

OTHER

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role collaborator

Cardiff University

OTHER

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jordan Grafman, PhD

Role: PRINCIPAL_INVESTIGATOR

Cognitive Neuroscience Section, NINDS, NIH

Andres Salazar, MD

Role: PRINCIPAL_INVESTIGATOR

NINDS, NIH

Locations

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National Naval Medical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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DAMD17-01-1-0675

Identifier Type: -

Identifier Source: org_study_id

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