Deployment Related Mild Traumatic Brain Injury (mTBI)

February 21, 2019 updated by: Karen Schwab, The Defense and Veterans Brain Injury Center

Deployment Related Mild Traumatic Brain Injury (mTBI): Incidence, Natural History, and Predictors of Recovery in Soldiers Returning From OIF/OEF

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Fort Carson, Colorado, United States, 80913
        • Fort Carson
    • North Carolina
      • Fort Bragg, North Carolina, United States
        • Fort Bragg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cohort of soldiers returning to Fort Bragg and Fort Carson returning from deployment to Iraq and Afghanistan. National Guard and Army Reservists serving on Active Duty will also be included.

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TBI while Deployed
Active duty service members returning from Afghanistan or Iraq who were screened positive for Mild TBI
No TBI while Deployed
Active duty service members returning from Afghanistan or Iraq who screened negative for mild TBI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Over time change in Concussive symptoms
Time Frame: Baseline; 3 months; 6 months; 12 months
Concussive symptoms are measured with 3 instruments: Neurobehavioral Symptom Inventory; Patient Health Questionnaire; Headache Questionnaire.
Baseline; 3 months; 6 months; 12 months
Change in Work Related Issues
Time Frame: 3 months; 6 months; 12 months
Measures of rates of return to duty; rates of return to work; and military job performance (for subjects remaining in military at follow-up).
3 months; 6 months; 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automated Neuropsychological Assessment Metrics (ANAM)
Time Frame: Pre-deployment testing; and upon return from deployment
The ANAM is a brief computerized cognitive assessment tool used for all individuals deploying to Afghanistan or Iraq; and administered after return from deployment.
Pre-deployment testing; and upon return from deployment
Change in Social Interaction
Time Frame: Baseline; 3 months; 6 months; 12 months
Quality and frequency of interactions with family, friends, and partners. Includes marital status, living arrangements, best friend, people can depend upon for help, comparative quality of relationships before deployment and currently, frequency of communication.
Baseline; 3 months; 6 months; 12 months
Alcohol and caffeine use
Time Frame: Baseline; 3 months; 6 months; 12 months

Frequency of alcohol consumption, pre and post deployment consumption, receipt of help.

Frequency of caffeine consumption, amount, consume with alcohol.
Baseline; 3 months; 6 months; 12 months
Health Utilization
Time Frame: Baseline; 3 months; 6 months; 12 months follow-up
Self-report and military data base information regarding type, and frequency of health care received. Also, self-reports on service needs.
Baseline; 3 months; 6 months; 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Defense and Veterans Brain Injury Center

Collaborators

Womack Army Medical Center
VISN 19 Mental Illness, Research, Education and Clinical Center
USUHS Preventive Medicine and Biometrics

Investigators

  • Principal Investigator: Karen Schwab, PhD, The Defense and Veterans Brain Injury Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (Estimate)

May 6, 2013

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-08-2-0105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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