Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deployment Related Mild Traumatic Brain Injury (mTBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847040
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : February 25, 2019
Sponsor:
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Mild Traumatic Brain Injury

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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 -
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Colorado
Fort Carson
Fort Carson, Colorado, United States, 80913
United States, North Carolina
Fort Bragg
Fort Bragg, North Carolina, United States
Sponsors and Collaborators
The Defense and Veterans Brain Injury Center
VISN 19 Mental Illness, Research, Education and Clinical Center
Womack Army Medical Center
USUHS Preventive Medicine and Biometrics
Investigators
Layout table for investigator information
Principal Investigator: Karen Schwab, PhD The Defense and Veterans Brain Injury Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Karen Schwab, Chief, Epidemiology and Research Support, The Defense and Veterans Brain Injury Center
ClinicalTrials.gov Identifier: NCT01847040    
Other Study ID Numbers: W81XWH-08-2-0105
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: May 2013
Keywords provided by Karen Schwab, The Defense and Veterans Brain Injury Center:
Traumatic Brain Injury
Epidemiology
Concussion
Outcomes
PTSD
Prospective
 Longitudinal
Military
Symptoms
Validation
Screening
Mild Traumatic Brain Injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating