Deployment Related Mild Traumatic Brain Injury (mTBI)
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|ClinicalTrials.gov Identifier: NCT01847040|
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : February 25, 2019
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:
- 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.
- 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).
- 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.
|Condition or disease|
|Mild Traumatic Brain Injury|
|Study Type :||Observational|
|Actual Enrollment :||750 participants|
|Official Title:||Deployment Related Mild Traumatic Brain Injury (mTBI): Incidence, Natural History, and Predictors of Recovery in Soldiers Returning From OIF/OEF|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2014|
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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847040
|United States, Colorado|
|Fort Carson, Colorado, United States, 80913|
|United States, North Carolina|
|Fort Bragg, North Carolina, United States|
|Principal Investigator:||Karen Schwab, PhD||The Defense and Veterans Brain Injury Center|