Deployment Related Mild Traumatic Brain Injury (mTBI)

The Defense and Veterans Brain Injury Center

Status: Completed

Conditions: Mild Traumatic Brain Injury

Study type: Observational

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT01847040

W81XWH-08-2-0105

Details and patient eligibility

About

The study will provide evidence on the long term outcomes of mTBI in service members returning from Afghanistan and Iraq. In addition, the study will provide evidence on mTBI incidence, and symptom patterns. Self-reported assessments at baseline and follow-ups will be combined with data on health care utilization and military job performance. The work, symptoms, and family interaction outcomes of returning soldiers screening positive for mTBI, combined mTBI and PTSD, and soldier controls will be compared at 3 months, 6 months, and at one year. The assessments over time will permit descriptions of symptom changes for these populations. It is likely the study will find similar findings to those of previous civilian studies - that concussive symptoms often resolve within months of injury. However, some soldier subsets may have chronic problems. Determining the incidence and outcomes of individuals with mTBI will assist medical providers in determining the types of follow-ups needed by returning service members and suggest the development of additional treatment interventions. These results may also inform treatment of civilian populations with mTBI.

The three primary hypotheses are:

1. Concussive symptoms at the time of return from serving in Afghanistan and Iraq and symptoms persisting 3 months, 6 months, and 12 months after return will be associated with extent of exposure to combat, injury mechanism, associated injuries (co-occuring injuries), PTSD and other psychiatric co-morbidities, and number of deployment-related mTBIs.
2. Returning troops reporting concussive symptoms at the time of return from deployment will have more work related problems at each follow-up (including lower rates of return to duty, return to work, and poor quality of work).
3. The mTBI screening tool will be sensitive and specific to mTBI when compared to the criterion measure, which is a structured interview conducted by clinicians blinded to the screening results.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Must be returning from deployment in Iraq or Afghanistan
2. Must have been screened for mild TBI on the deployment related study screening tool
3. Must sign an informed consent/HIPAA authorization -

Exclusion criteria

1. Returning from deployment for medical reasons, that is, medically evacuated to the Continental US
2. Unable or unwilling to provide informed consent/HIPAA authorization -

Trial design

750 participants in 2 patient groups

TBI while Deployed

Description:

Active duty service members returning from Afghanistan or Iraq who were screened positive for Mild TBI

No TBI while Deployed

Description:

Active duty service members returning from Afghanistan or Iraq who screened negative for mild TBI.