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Vietnam Head Injury Study - Phase III

This study is currently recruiting participants.
Verified by U.S. Army Medical Research and Materiel Command, August 2005

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
Study Design:   Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
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:

Estimated Enrollment:   500
Study Start Date:   April 2004
Estimated Study Completion Date:   April 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

Contacts
Contact: Sandra L Bonifant, BS     301-319-8471     BonifanS@ninds.nih.gov    
Contact: Faith Bradford     301-319-8470     FABradford@bethesda.med.navy.mil    

Locations
United States, Maryland
National Naval Medical Center     Recruiting
      Bethesda, Maryland, United States, 20889
      Contact: Sandra L Bonifant, BS     301-319-8471     BonifanS@ninds.nih.gov    
      Sub-Investigator: Vanessa Raymont, MB, ChB            
      Principal Investigator: John Hughes, MD, NNMC            

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
First Received:   August 17, 2005
Last Updated:   September 5, 2006
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 November 05, 2008




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