Traumatic Brain InjuryNCT00132249
Vietnam Head Injury Study - Phase III
An observational study of Traumatic Brain Injury and Penetrating Head Injury, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Penetrating Head Injury, Closed Head Trauma
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 199 head-injured subjects attended PH3. 55 control subjects attended PH3.
Who may be able to join
- Vietnam Veteran
- Served in active combat between 1966 - 1971
- Male
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Naval Medical Center
Bethesda, Maryland, 20889
About this study
Official title: A 40+ Year Post-Injury Follow-Up Study of Vietnam Veterans Who Sustained Traumatic Brain Injury While in Combat.
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.
Read the 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.
- Keywords
- Traumatic Brain Injury, Penetrating head wound, Closed head trauma, Vietnam Veteran
- Medical subject headings
- Brain Injuries, Traumatic, Head Injuries, Penetrating, Head Injuries, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head Injured | The Vietnam Head Injured Subjects | |
| Head Uninjured | Uninjured Vietnam Veteran Control Subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
the assessment of a large number of the genetic markers and the relation to various out come measures.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startApr 2004
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- 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
- Responsible party
- Sponsor
- Investigators
- Jordan Grafman, PhD, Principal investigator, Cognitive Neuroscience Section, NINDS, NIHAndres Salazar, MD, Principal investigator, NINDS, NIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132249
- Sponsor's protocol ID
- DAMD17-01-1-0675
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2005
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 40+ Year Post-Injury Follow-Up Study of Vietnam Veterans Who Sustained Traumatic Brain Injury While in Combat.
- ClinicalTrials.gov ID
- NCT00132249
- Acronym / sponsor ID
- DAMD17-01-1-0675
- Keywords
- Traumatic Brain Injury, Penetrating head wound, Closed head trauma, Vietnam Veteran
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- 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
- Study start
- Apr 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head Injured | – | –The Vietnam Head Injured Subjects |
| Head Uninjured | – | –Uninjured Vietnam Veteran Control Subjects |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 199 head-injured subjects attended PH3. 55 control subjects attended PH3.
Key inclusion criteria (3 listed)
- Vietnam Veteran
- Served in active combat between 1966 - 1971
- Male
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the assessment of a large number of the genetic markers and the relation to various out come measures.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Grafman, PhD principal investigator
Cognitive Neuroscience Section, NINDS, NIH
Andres Salazar, MD principal investigator
NINDS, NIH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Penetrating Head Injury, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the assessment of a large number of the genetic markers and the relation to various out come measures. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018; AzTrials last refreshed its copy on 1 Nov 2026.