MRI Outcomes of Mindfulness Meditation for Migraine

Not Applicable

Completed

• Conditions: Migraine

• Registration Number: NCT02133209
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-04-21
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Maryland School of Dentistry; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins University, Bayview Medical Campus; 🇺🇸 Baltimore, Maryland, United States