TerminatedNot Applicable

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

Stopped: unable to recruit sufficent subjects

United States21 participantsStarted 2013-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and female veterans at least 18 years of age * Mild post traumatic headaches, diagnosed by a physician * No prior training in MBSR or other mindfulness or meditation training will be allowed * Able to read and speak English * No participation in a clinical trial within the last 28 days Exclusion Criteria: * Current severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder, claustrophobia, history of panic attacks) * Significant co-morbid condition(s) such as insulin-dependent diabetes, cancer, obesity (BMI\>35), severe lung disease, neurological conditions (e.g., seizures), uncontrolled hypertension, or significant heart disease * History of persistent headaches prior to TBI * Unsafe for MRI (e.g., metal objects/shrapnel, metallic implants, brain or skull abnormalities, and claustrophobia) * Use of centrally acting medications that will interfere with the neuroimaging testing (e.g. narcotic medications) * Daily use of illicit drugs or marijuana * Daily alcohol consumption of greater than 2 units

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Validate Optimal Biomarker candidates

Timeframe: After MBSR training (9 weeks)

Trial details

NCT IDNCT02145117

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04-01

View on ClinicalTrials.gov More Post Traumatic Headache trials