Deployment Related Mild Traumatic Brain Injury (mTBI)

NCT01847040 | Completed

• 1 other identifier: W81XWH-08-2-0105
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 2

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. 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. 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. 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.

Conditions

Mild Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Epidemiology; Concussion; Outcomes; PTSD; Prospective; Longitudinal; Military; Symptoms; Validation; Screening; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Over time change in Concussive symptoms

  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

  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 Outcomes (4)

• Automated Neuropsychological Assessment Metrics (ANAM)

  Pre-deployment testing; and upon return from deployment

• Change in Social Interaction

  Baseline; 3 months; 6 months; 12 months

• Alcohol and caffeine use

  Baseline; 3 months; 6 months; 12 months

• Health Utilization

  Baseline; 3 months; 6 months; 12 months follow-up

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Must be returning from deployment in Iraq or Afghanistan
• Must have been screened for mild TBI on the deployment related study screening tool
• Must sign an informed consent/HIPAA authorization -

You may not qualify if:

• Returning from deployment for medical reasons, that is, medically evacuated to the Continental US
• Unable or unwilling to provide informed consent/HIPAA authorization -

Sponsors & Collaborators

• The Defense and Veterans Brain Injury Center: lead
• VISN 19 Mental Illness, Research, Education and Clinical Center: collaborator
• Womack Army Medical Center: collaborator
• USUHS Preventive Medicine and Biometrics: collaborator

Study Sites (2)

Fort Carson

Fort Carson, Colorado, 80913, United States

Location

Fort Bragg

Fort Bragg, North Carolina, United States

Location

Related Publications (6)

• Ivins B, Risling M, Wisen N, Schwab K, Rostami E. Mild Traumatic Brain Injury in the Maturing Brain: An Investigation of Symptoms and Cognitive Performance in Soldiers Returning From Afghanistan and Iraq. J Head Trauma Rehabil. 2024 Jul-Aug 01;39(4):304-317. doi: 10.1097/HTR.0000000000000919. Epub 2023 Dec 7.

  PMID: 38059837 DERIVED

• Scher AI, McGinley JS, VanDam LR, Campbell AM, Chai X, Collins B, Klimp SA, Finkel AG, Schwab K, Lipton RB, Johnson KW. Plasma calcitonin gene-related peptide and nerve growth factor as headache and pain biomarkers in recently deployed soldiers with and without a recent concussion. Headache. 2023 Oct;63(9):1240-1250. doi: 10.1111/head.14635. Epub 2023 Oct 5.

  PMID: 37796114 DERIVED

• 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.

  PMID: 33242991 DERIVED

• 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.

  PMID: 31924681 DERIVED

• 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.

  PMID: 31368742 DERIVED

• 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.

  PMID: 28314862 DERIVED

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Karen Schwab, PhD

  The Defense and Veterans Brain Injury Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Epidemiology and Research Support

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 6, 2013
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: February 25, 2019

Record last verified: 2013-05

Locations

US (2)