MRI Outcomes of Mindfulness Meditation for Migraine

Study Overview
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Brief Summary
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112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including headache frequency and impact and brain activity, will be assessed at baseline, prior to intervention, and at 3-, 6-, and 12-months.

Detailed Description
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Subjects in the MBSR group undergo a standardized 8-week MBSR course plus an additional 4 sessions over another 8 weeks that further emphasize and train subjects on MBSR concepts and skills. The SMH group will have 12 sessions spread out in a similar fashion to MBSR. Clinical outcomes are compared between groups at 3, 6, and 12 months to assess efficacy of MBSR. MRI scans are performed at baseline, 3 months, and 6 months changes in MRI metrics after MBSR and changes in MRI metrics associated with long-term MBSR practice. 30 healthy controls will also undergo MRI scanning to determine abnormal brain activity and structure in migraineurs compared to healthy controls across the 6 month period of observation.

Official Title
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MRI Outcomes of Mindfulness Meditation for Migraine

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction
* Behavioral: Stress Management for Headaches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Are between 18 and 65 years of age Report between 4 and 14 headaches over 28 days Have a history of migraines lasting at least 1 year Are not currently using opioid (narcotic) pain medication Exclusion Criteria Are unable to undergo MRI Pregnant, lactating, or planning to become pregnant Current use of opioid medications Inclusion Criteria for Healthy Volunteers (same exclusion criteria) Are between 18 and 65 years of age Free of any acute or chronic pain condition and reports no history of migraines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stress Management for Headaches<br>This intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills for managing migraine headaches. | Behavioral: Stress Management for Headaches<br>* Intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills, headache symptoms and their management, sleep hygiene, and healthy eating. There will be 8 weekly sessions followed by 4 bi-weekly sessions over a period of 4 months.<br>|
| Active Comparator: Mindfulness Based Stress Reduction<br>Intervention involves a standardized mindfulness-based stress reduction (MBSR) group intervention following the guidelines originally conceived and developed by the Center for Mindfulness in Medicine, Health Care and Society at the University of Massachusetts. The intervention also included an extended period of training in addition to the usual 8 weeks. | Behavioral: Mindfulness Based Stress Reduction<br>* Mindfulness Based Stress Reduction (MBSR) involves focused attention while practicing moment-to-moment nonjudgmental awareness of the self with the goal of achieving emotional balance and clarity of thought. There will be 8 weekly sessions and a half day retreat followed by 4 bi-weekly sessions over a period of 4 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in headache frequency and impact | Headache days per 28 days and headache-related disability (HIT-6) | Baseline, 3, 6, and 12 months | 
| Change in gray matter volume | Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate | Baseline, 3, and 6 months | 
| Change in Brain Function | Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula | Baseline, 3, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in headache intensity | Change in headache intensity | Baseline, 3, 6, and 12 months | 
| Change in Brain Structure | Gray matter volume and white matter tracts across the whole brain | Baseline, 3, and 6 months | 
| Change in Whole Brain Function | Cognitive-related activity, pain-related activity, and resting state across the whole brain | Baseline, 3, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, headache, meditation, mindfulness based stress reduction, MBSR