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Mild Traumatic Brain InjuryNCT01847040

Deployment Related Mild Traumatic Brain Injury (mTBI)

An observational study of Mild Traumatic Brain Injury, run by The Defense and Veterans Brain Injury Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mild Traumatic Brain Injury
How many people
750 participants
Where
2 sitesUnited States
Study dates
Sep 2009to Aug 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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 -

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Fort Bragg

    Fort Bragg, North Carolina

  • Fort Carson

    Fort Carson, Colorado, 80913

Other trials in United States

About this study

Official title: Deployment Related Mild Traumatic Brain Injury (mTBI): Incidence, Natural History, and Predictors of Recovery in Soldiers Returning From OIF/OEF

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.
Keywords
Traumatic Brain Injury, Epidemiology, Concussion, Outcomes, PTSD, Prospective, Longitudinal, Military, Symptoms, Validation, Screening, Mild Traumatic Brain Injury
Medical subject headings
Brain Concussion, Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01847040
Study groupRoleWhat they receive
TBI while DeployedActive duty service members returning from Afghanistan or Iraq who were screened positive for Mild TBI
No TBI while DeployedActive duty service members returning from Afghanistan or Iraq who screened negative for mild TBI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Over time change in Concussive symptoms

    Concussive symptoms are measured with 3 instruments: Neurobehavioral Symptom Inventory; Patient Health Questionnaire; Headache Questionnaire.

    Measured: Baseline; 3 months; 6 months; 12 months

  2. 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).

    Measured: 3 months; 6 months; 12 months

Secondary outcomes (4)

  1. Automated Neuropsychological Assessment Metrics (ANAM)

    The ANAM is a brief computerized cognitive assessment tool used for all individuals deploying to Afghanistan or Iraq; and administered after return from deployment.

    Measured: Pre-deployment testing; and upon return from deployment

  2. Change in Social Interaction

    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.

    Measured: Baseline; 3 months; 6 months; 12 months

  3. Alcohol and caffeine use

    Frequency of alcohol consumption, pre and post deployment consumption, receipt of help.

    Frequency of caffeine consumption, amount, consume with alcohol.

    Measured: Baseline; 3 months; 6 months; 12 months

  4. Health Utilization

    Self-report and military data base information regarding type, and frequency of health care received. Also, self-reports on service needs.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2013 (estimated)
  2. Study startSep 2009
  3. Primary completionAug 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
750 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847040
Sponsor's protocol ID
W81XWH-08-2-0105
Status last verified
May 2013
First submitted
26 Apr 2013
Last updated
25 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38059837

  • 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.

    PubMed 37796114

  • 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.

    PubMed 33242991

  • 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.

    PubMed 31924681

  • 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.

    PubMed 31368742

  • 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.

    PubMed 28314862

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Traumatic Brain Injury, run by The Defense and Veterans Brain Injury Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Over time change in Concussive symptoms (time frame: Baseline; 3 months; 6 months; 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01847040, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.

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