MRI Outcomes of Mindfulness Meditation for Migraine

Johns Hopkins University98 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Migraine

Interventions

Mindfulness Based Stress ReductionBEHAVIORAL

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.

Stress Management for HeadachesBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Maryland School of Dentistry

Baltimore, Maryland, United States

Johns Hopkins University, Bayview Medical Campus

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Change in headache frequency and impact

Headache days per 28 days and headache-related disability (HIT-6)

Time frame: Baseline, 3, 6, and 12 months

Change in gray matter volume

Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate

Time frame: 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

Time frame: Baseline, 3, and 6 months

Secondary Outcomes

Change in headache intensity

Time frame: Baseline, 3, 6, and 12 months

Change in Brain Structure

Gray matter volume and white matter tracts across the whole brain

Time frame: Baseline, 3, and 6 months

Change in Whole Brain Function

Cognitive-related activity, pain-related activity, and resting state across the whole brain

Time frame: Baseline, 3, and 6 months

Data from ClinicalTrials.gov

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