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Vietnam Head Injury Study - Phase III

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00132249
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : August 16, 2018
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

Study Description
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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.

Condition or disease
Traumatic Brain Injury Penetrating Head Injury Closed Head Trauma

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 Design
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Study Type : Observational
Actual Enrollment : 254 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: A 40+ Year Post-Injury Follow-Up Study of Vietnam Veterans Who Sustained Traumatic Brain Injury While in Combat.
Study Start Date : April 2004
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Groups and Cohorts
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Group/Cohort
Head Injured
The Vietnam Head Injured Subjects
Head Uninjured
Uninjured Vietnam Veteran Control Subjects


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
199 head-injured subjects attended PH3. 55 control subjects attended PH3.
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132249


Locations
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United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
U.S. Army Medical Research and Development 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
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Principal Investigator: Jordan Grafman, PhD Cognitive Neuroscience Section, NINDS, NIH
Principal Investigator: Andres Salazar, MD NINDS, NIH
More Information
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00132249    
Other Study ID Numbers: DAMD17-01-1-0675
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Keywords provided by U.S. Army Medical Research and Development Command:
Traumatic Brain Injury
Penetrating head wound
Closed head trauma
Vietnam Veteran
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Head Injuries, Penetrating
Head Injuries, Closed
Wounds and Injuries
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds, Penetrating
Wounds, Nonpenetrating