NCT00132249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

6.4 years

First QC Date

August 17, 2005

Last Update Submit

August 15, 2018

Conditions

Traumatic Brain InjuryPenetrating Head InjuryClosed Head Trauma

Keywords

Traumatic Brain InjuryPenetrating head woundClosed head traumaVietnam Veteran

Outcome Measures

Primary Outcomes (1)

  • the assessment of a large number of the genetic markers and the relation to various out come measures.

    3 years

Study Arms (2)

Head Injured

The Vietnam Head Injured Subjects

Head Uninjured

Uninjured Vietnam Veteran Control Subjects

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

199 head-injured subjects attended PH3. 55 control subjects attended PH3.

You may qualify if:

  • Vietnam Veteran
  • Served in active combat between 1966 - 1971
  • Male

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticHead Injuries, PenetratingHead Injuries, Closed

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesWounds, PenetratingWounds, Nonpenetrating

Study Officials

  • Jordan Grafman, PhD

    Cognitive Neuroscience Section, NINDS, NIH

    PRINCIPAL INVESTIGATOR

  • Andres Salazar, MD

    NINDS, NIH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 19, 2005

Study Start

April 1, 2004

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

US(1)