UNC Study of Brain Function and Cognitive Rehabilitation
Start Date 2011-08-03
End Date 2015-10-31
Eligibility Requirements
Eligibility
Gender
Gender
Male
Female
Other
Age Range
Age Range
18 - 25 years
26 - 30 years
31 - 45 years
56 and more years
Vetaran Status
Vetaran Status
Served
Active
Service Range
Service Range
0 - 15 years
16 - 20 years
21 and more years
Deployment Status
Deployment Status
Never
Within 2 years
Military Affiliation
Military Affiliation
Army
Navy
Airforce
Marine
Coast Guard
National Guard
Reserves
Short Description
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 problems in what are called 'executive functions' such as planning actions, inhibiting behavior, monitoring one's own thoughts and feelings, and solving problems day-to-day. These types of impairments occur more often among veterans with both TBI and PTSD than among those with only one of these conditions. The combination of TBI and PTSD in veterans has also been linked to problems with anger and violence, which are common complaints of veterans seeking mental health services post-deployment and have been shown to predict poor treatment outcomes in Iraq and Afghanistan veterans. Although the relationship between combined TBI/PTSD diagnoses and post-deployment adjustment problems has been demonstrated, there has been little research into clinical interventions designed to reduce the severity of cognitive and affective symptoms in veterans with both TBI and PTSD. Therefore, the investigators propose a randomized clinical trial involving a cognitive rehabilitation intervention that targets improved executive functioning, with the participation of N=100 veterans diagnosed with both TBI and PTSD (n=50 in experimental group and n=50 comparison). As part of the study, all participants will receive an iPod touch. Participants will be placed into one of the two study groups randomly. Based on which group participants are placed in, they will receive one of two different sets of iPod touch apps and programs that address and aim to improve different facets of cognitive functioning. Regardless of which group, Veterans will be instructed to daily practice iPod touch applications on cognitive functioning. Also, family members will be trained as "mentors" to reinforce use of the applications in everyday living environments. Trained facilitators will also travel to participants' homes to meet with veterans and family to observe behaviors in the home environment, arrive at strategies for applying new skills in their situations, troubleshoot any iPod technical problems, and review family mentoring processes. The investigators will measure clinical outcomes using a comprehensive array of functional and structural methods at baseline and six months. The investigators hypothesize improved executive function among those in the experimental group as well as reduced irritability/impulsivity and improved social/occupational functioning. The investigators further hypothesize that, as a group, veterans participating in the cognitive rehabilitation program will show significant changes in neural activity associated with executive functions when comparing pre- and post-treatment EEG and fMRI responses. Better understanding of the neural circuitry and neurocognitive function underlying executive function and associated affective control deficits in veterans with both TBI and PTSD, and how they relate to treatment outcome, will allow us to better identify therapeutic targets for cognitive rehabilitation. The current proposal aims to explore the relationship between brain function and connectivity in selective pathways/circuits, neuropsychological functioning, and cognitive rehabilitation response in veterans with both TBI and PTSD. This study of the neurobiology and neuropsychology associated with intervention efficacy will allow us to identify veterans with both TBI and PTSD who are predisposed to positive treatment outcomes. To our knowledge, this will be the first attempt to integrate neurobiological and neurocognitive techniques with information about the efficacy of a theoretically and empirically driven cognitive rehabilitation intervention in veterans with combined TBI/PTSD diagnoses. This research may suggest additional avenues for assessment of clinical intervention efficacy and the identification of therapeutic targets (e.g. alteration of function in fronto-limbic circuits) relevant to the military population. Given links between TBI/PTSD, executive dysfunction, and anger, impulsivity, and aggression, efforts to rehabilitate cognitive function will be particularly important to ensure that current and future veterans adjust successfully when they return home to their families, workplaces, and communities.
Location Info
Conducted in
Chapel Hill , North Carolina
Privacy of the Participants
Does this study require the individual's medical records? - No
Does the sponsor require the name of study participants to be provided? - No
Is this study required to provide individual results to the sponsor? - No
Is this study anonymous in the sense that patient identity is completely anonymized? - No
Contact Details
Eric Elbogen, Ph.D. 919-972-7459 vetstudy@unc.edu
Research Topics
Post Traumatic Stress Disorder (PTSD)
Memory
Traumatic Brain Injury (TBI)
Injury and Trauma (Physical and Mental)
Mental Health
More Info
Has this study and the posting of this study on AllyResearch.org been IRB approved - Yes
Are healthy subjects accepted? - No
Does this study utilize any drug treatments? - No
Are there financial incentives to participate? - Yes
Financial Incentive for this study : $500 and iPod
Official title: Neural Markers and Rehabilitation of Executive Functioning in Veterans With Traumatic Brain Injury and Posttraumatic Stress Disorder
University IRB
11-1292
Study ID #
NCT01410721
Lead Researcher
Eric , Elbogen, Ph.D.
Sponsored By
University of North Carolina, Chapel Hill