Deployment Related Mild Traumatic Brain Injury (mTBI)

• ClinicalTrials.gov Identifier: NCT01847040
• Recruitment Status: Completed
• First Posted: May 6, 2013
• Last Update Posted: February 25, 2019
• Sponsor: The Defense and Veterans Brain Injury Center
• Collaborators: VISN 19 Mental Illness, Research, Education and Clinical Center; Womack Army Medical Center; USUHS Preventive Medicine and Biometrics
• Information provided by (Responsible Party): Karen Schwab, The Defense and Veterans Brain Injury Center

Tracking Information

• First Submitted Date: April 26, 2013
• First Posted Date: May 6, 2013
• Last Update Posted Date: February 25, 2019
• Study Start Date: September 2009
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2013)

• 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 1, 2013)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Mild Traumatic Brain Injury
• Intervention: Not Provided

Study Groups/Cohorts

• 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.

Publications *

• 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. 2020 Nov 27:333102420974352. doi: 10.1177/0333102420974352. [Epub ahead of print]
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 21, 2019): 750
• Original Estimated Enrollment (submitted: May 1, 2013): 1500
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

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 -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01847040
• Other Study ID Numbers: W81XWH-08-2-0105
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Karen Schwab, The Defense and Veterans Brain Injury Center
• Study Sponsor: The Defense and Veterans Brain Injury Center

Collaborators

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

Investigators

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

• PRS Account: The Defense and Veterans Brain Injury Center
• Verification Date: May 2013