Clinical Trial: Brain Biomarkers w/Mind-Body Tx in Veterans With Post Traumatic Headache (PTH)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Neuroimaging Biomarkers of Mind-Body Treatment in Veterans With Post Traumatic Headache (PTH)

Brief Summary: This project aims to develop and test structural and functional brain imaging biomarkers for improvement in chronic pain from a mind/body intervention perspective in a critical veteran population, namely veterans with post traumatic headache (PTH) associated with mild traumatic brain injury (TBI). The project also aims to examine feasibility in a sample of veterans with PTH of performing resting state and structural neuroimaging protocols, and of obtaining active participation and completion of MBSR training. Lastly, exploratory analysis of brain imaging data will be performed to determine if hypothesized candidate biomarkers are associated with positive outcomes from MBSR and determine estimated effect sizes for future studies in PTH population.

Detailed Summary:

Returning veterans from Iraq and Afghanistan (OIF/OEF veterans) have a very high incidence of TBI (14-23%) with the largest number having mild TBI (i.e., no discernible structural brain damage) with 63.5% having persistent headache. Treatment of PTH in this population has been difficult and mind/body interventions including Mindfulness Based Stress Reduction (MBSR) may offer significant benefit. A biomarker that will support clinical endpoints ("surrogate endpoint") and help predict clinical benefit, could be used to more efficiently and completely assess mind/body treatment effects in clinical trials for PTH, compare various complementary and alternative medicine (CAM) treatments, and potentially target specific treatments to patients most likely to benefit. This project aims to investigate candidate biomarkers for MBSR response in veterans with PTH. Primarily, all subjects if they are interested and appropriate for the study, will undergo a screening at their regular clinic visit at the VAGLAS physical medicine and rehab department. If a subject responds to advertisement they will be screened using the same tools and enrollment criteria required for the veterans at VAGLAS. We expect we will need to enroll and screen no less than 33 subjects in order to complete 20 evaluable subjects for analysis. The study subjects will be evaluated for the severity of their PTH, the impact of PTH on their life, and the extent of the disease/pain condition. If eligible the nurse coordinator will contact them to schedule the pre-MBSR functional MRI visit. At the MRI we will evaluate patterns of activity (functional connectivity) in the brain at rest, and look at cortical thickness. Following the MRI visit all subjects will complete a 9-week modified MBSR training with a qualified instructor. Mid-study (after MBSR class 4) the subject will be asked to complete mid-study questionnaires at home on Survey Monkey or on paper if the
Sponsor: University of California, Los Angeles

Current Primary Outcome: Validate Optimal Biomarker candidates [ Time Frame: After MBSR training (9 weeks) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Specificity, generality and moderation of biomarker response to MBSR treatment [ Time Frame: Post MBSR training at 3 month follow up ]

Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: May 20, 2014
Date Started: September 2013
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017