Status:
COMPLETED
Neural Markers and Rehabilitation of Executive Functioning in Veterans With Traumatic Brain Injury and Posttraumatic Stress Disorder
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
United States Department of Defense
Foundation of Hope, North Carolina
Conditions:
Traumatic Brain Injury
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Up to half of all military service members with combat-related traumatic brain injury (TBI) also suffer from Posttraumatic Stress Disorder (PTSD). TBI and PTSD are each associated with cognitive probl...
Detailed Description
Background: It is estimated that up to half of all military service members with combat-related traumatic brain injury (TBI) also meet criteria for Posttraumatic Stress Disorder (PTSD). TBI and PTSD a...
Eligibility Criteria
Inclusion
- OIF/OEF Veteran inclusion criteria include:
- has served in one of the military branches (Army, Navy, Marines, Air Force, National Guard);
- is between the ages of 18 and 65;
- has served in Iraq or Afghanistan War since October 2001;
- has screened positive for TBI and PTSD prior to baseline interview. Definition of TBI: The American Congress of Rehabilitation Medicine (ACRM) (Kay et al., 1993), Center for Disease Control (CDC, 2003), and Military TBI Task Force (http://www.div40.org/pdf/Military\_TBI.pdf) have sought to define criteria for different types of head injuries. In the current DoD application, for both the research registry and pre-screening, criteria for TBI should be defined as a veteran who: 1. reports that during military service, head was hurt/injured in a way that caused problems; AND 2. endorses at least one of the following:
- loss of consciousness or getting "knocked out."
- immediately after the injury or upon regaining consciousness, being dazed or "seeing stars."
- immediately after the injury or upon regaining consciousness, being unable to recall the event.
- being over one hour after the injury was it before veteran started remembering new things again.
- needing brain surgery after the injury.
- Definition of PTSD: For the purposes of the current research, we use the Diagnostic Statistical Manual-IV-TD (DSM-IV-TR) definition of PTSD for the purposes of the current research. Specifically, subjects must report a traumatic event according to DSM criteria and report experiencing re-experiencing, avoidance, and hyperarousal symptoms to qualify for the diagnosis. Study registries define PTSD as having a score above the cut-off of 60 on the Clinical Assessment of PTSD (CAPS). We will re-screen potential participants before enrollment by administering the PTSD Checklist, scores above 50 indicative of PTSD among OIF/OEF veterans. Please note below that the CAPS will be administered as part of the main clinical interview after veterans have signed informed consent.
- Family member inclusion criteria include: (1) has family member/friend who served in one of the military branches (Army, Navy, Marines, Air Force, National Guard); (2) age 18-65; and (3) has family member who served at least one tour in Iraq or Afghanistan since October 2001 and meets above criteria Inclusion of Women and Minorities in Study: It is anticipated that the distribution of our sample by gender and race/ethnicity will reflect the client population served by the North Carolina healthcare system. No one will be excluded from the study because of gender or racial/ethnic group.
Exclusion
- Since MRI sessions are a part of the study, subjects should not participant if:
- They have any foreign metal objects or implants in their body as determined by the safety questionnaires.
- Veteran is a woman and is pregnant or unwilling to take a pregnancy test.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT01410721
Start Date
January 1 2012
End Date
February 1 2016
Last Update
December 13 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UNC
Chapel Hill, North Carolina, United States, 27599