Post Traumatic Headache Clinical Trial
Official title:
Neuroimaging Biomarkers of Mind-Body Treatment in Veterans With Post Traumatic Headache (PTH)
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.
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 they choose. At the end of the MBSR training in which
the subject will have to complete at least 3 visits, functional (f)MRI procedure will be
repeated and compared against the first. Three months after completing the study there will
be a follow-up visit to complete behavioral/symptom/quality of life questionnaires on line
via SurveyMonkey. This is to see if the changes in the biomarkers will mediate changes in
these behavioral measures 3-mo post Treatment (i.e. measure stability).
All in all, to complete the study subjects will have a screening visit, pre and post training
MRI visit, up to 9 MBSR training visits, mid study questionnaires, a 4-hr retreat visit after
week 6 and a final 3-mo f/u visit for questionnaires only.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01993069 -
Yoga Training for Returning Veterans With Headache
|
N/A | |
| Terminated |
NCT00487578 -
Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction
|
Phase 4 |