Deployment Related Mild Traumatic Brain Injury (mTBI)

Completed

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT01847040
• Lead Sponsor: The Defense and Veterans Brain Injury Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2013-04-26
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-06
• Primary Completion: 2013-08
• Study Completion: 2014-08
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Over time change in Concussive symptoms	Baseline; 3 months; 6 months; 12 months	Concussive symptoms are measured with 3 instruments: Neurobehavioral Symptom Inventory; Patient Health Questionnaire; Headache Questionnaire.
Change in Work Related Issues	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).

Secondary Outcome Measures

Name	Time	Method
Change in Social Interaction	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.
Alcohol and caffeine use	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.
Health Utilization	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.
Automated Neuropsychological Assessment Metrics (ANAM)	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.

Trial Locations

Locations (2)

Fort Carson; 🇺🇸 Fort Carson, Colorado, United States

Fort Bragg; 🇺🇸 Fort Bragg, North Carolina, United States