Clinical trial NCT01847040: Deployment Related Mild Traumatic Brain Injury (mTBI)
Official title: Deployment Related Mild Traumatic Brain Injury (mTBI): Incidence, Natural History, and Predictors of Recovery in Soldiers Returning From OIF/OEF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Epidemiology
Concussion
Outcomes
PTSD
Prospective
Longitudinal
Military
Symptoms
Validation
Screening
Mild Traumatic Brain Injury
Lead sponsor: The Defense and Veterans Brain Injury Center
Sponsor class: FED
Collaborators: name: VISN 19 Mental Illness, Research, Education and Clinical Center
name: Womack Army Medical Center
name: USUHS Preventive Medicine and Biometrics
First posted: 2013-05-06
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: Over time change in Concussive symptoms
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in Work Related Issues
timeFrame: 3 months; 6 months; 12 months
Secondary outcomes:
measure: Automated Neuropsychological Assessment Metrics (ANAM)
timeFrame: Pre-deployment testing; and upon return from deployment
measure: Change in Social Interaction
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Alcohol and caffeine use
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Health Utilization
timeFrame: Baseline; 3 months; 6 months; 12 months follow-up
Other outcomes:
Locations:
city: Fort Carson
country: United States
facility: Fort Carson
state: Colorado
city: Fort Bragg
country: United States
facility: Fort Bragg
state: North Carolina
Study officials:
affiliation: The Defense and Veterans Brain Injury Center
name: Karen Schwab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scher AI, McGinley JS, Wirth RJ, Lipton RB, Terrio H, Brenner LA, Cole WR, Schwab K. Headache complexity (number of symptom features) differentiates post-traumatic from non-traumatic headaches. Cephalalgia. 2021 Apr;41(5):582-592. doi: 10.1177/0333102420974352. Epub 2020 Nov 27.
citation: Metti A, Schwab K, Finkel A, Pazdan R, Brenner L, Cole W, Terrio H, Scher AI. Posttraumatic vs nontraumatic headaches: A phenotypic analysis in a military population. Neurology. 2020 Mar 17;94(11):e1137-e1146. doi: 10.1212/WNL.0000000000008935. Epub 2020 Jan 10.
citation: Betthauser LM, Adams RS, Hostetter TA, Scher AI, Schwab K, Brenner LA. Characterization of lifetime TBIs in a cohort of recently deployed soldiers: The warrior strong study. Rehabil Psychol. 2019 Nov;64(4):398-406. doi: 10.1037/rep0000286. Epub 2019 Aug 1.
citation: Schwab K, Terrio HP, Brenner LA, Pazdan RM, McMillan HP, MacDonald M, Hinds SR 2nd, Scher AI. Epidemiology and prognosis of mild traumatic brain injury in returning soldiers: A cohort study. Neurology. 2017 Apr 18;88(16):1571-1579. doi: 10.1212/WNL.0000000000003839. Epub 2017 Mar 17.