Deployment Related Mild Traumatic Brain Injury (mTBI)

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847040
• Other study ID #: W81XWH-08-2-0105
• Status: Completed
• Start date: September 2009
• Est. completion date: August 2014

Study information

• Verified date: May 2013
• Source: The Defense and Veterans Brain Injury Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: August 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Fort Bragg	Fort Bragg	North Carolina
United States	Fort Carson	Fort Carson	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
The Defense and Veterans Brain Injury Center	USUHS Preventive Medicine and Biometrics, VISN 19 Mental Illness, Research, Education and Clinical Center, Womack Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Pre-deployment testing; and upon return from deployment
Secondary	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.	Baseline; 3 months; 6 months; 12 months
Secondary	Alcohol and caffeine use	Frequency of alcohol consumption, pre and post deployment consumption, receipt of help.; Frequency of caffeine consumption, amount, consume with alcohol.	Baseline; 3 months; 6 months; 12 months
Secondary	Health Utilization	Self-report and military data base information regarding type, and frequency of health care received. Also, self-reports on service needs.	Baseline; 3 months; 6 months; 12 months follow-up