Clinical Trial: Vietnam Head Injury Study - Phase III
This study is currently recruiting patients.
Verified by U.S. Army Medical Research and Materiel Command August 2005
| Sponsors and Collaborators: | U.S. Army Medical Research and Materiel Command USAMRMC is the only funding source. Data collaborator include: Cognitive Neuroscience Section, National Institute of Neurological Disorders and Stroke (NINDS), NIH George Mason University Laboratory of Neurogenetics, National Institute on Alcohol Abuse and Alcoholism (NIAAA), NIH Speech-Language Pathology Section, Rehabilitation Medicine Department, Clinical Center, NIH Department of Psychology, University of York, Toronto, Canada Mood and Anxiety Disorders Research Program, Experimental Therapeutics and Pathology Branch, National Institute on Mental Health (NIMH), NIH Department of Psychology, University of Hertfordshire, Hatfield, United Kingdom Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia School of Psychology, Cardiff University, Cardiff, United Kingdom | | Information provided by: | U.S. Army Medical Research and Materiel Command | | ClinicalTrials.gov Identifier: | NCT00132249 | |
Purpose
The Vietnam Head Injusy 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 wounds Closed Head Trauma TBI
| Phase III
|
MedlinePlus related topics: Head and Brain Injuries
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:
Expected Total Enrollment: 500
Study start: April 2004
Last follow-up: April 2007
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
Criteria
We are seeking healthy CONTROL particpants.
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00132249
Sandra L Bonifant, BS 301-319-8471 BonifanS@ninds.nih.gov
Faith Bradford 301-319-8470 FABradford@bethesda.med.navy.mil
Maryland National Naval Medical Center, Bethesda, Maryland, 20889, United States; Recruiting
Sandra L Bonifant, BS 301-319-8471 BonifanS@ninds.nih.gov
Vanessa Raymont, MB, ChB, Sub-Investigator
John Hughes, MD, Principal Investigator
Study chairs or principal investigators
Jordan Grafman, PhD, Principal Investigator, Cognitive Neuroscience Section, NINDS,
NIH Andres Salazar, MD, Principal Investigator, NINDS,
NIH
More Information
Cognitive Neuroscience Section Home Page
Study ID Numbers: DAMD17-01-1-0675; NNMC
IRB ID# B03-043
Last Updated: August 18, 2005
Record first received: August 17, 2005
ClinicalTrials.gov Identifier: NCT00132249
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23
Source: ClinicalTrials.gov
Cache Date: August 24, 2005
Resources
- Anoxia (National Institute of Neurological Disorders and Stroke)
- Brain Injury (National Institute of Neurological Disorders and Stroke)