MRI Outcomes of Mindfulness Meditation for Migraine

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Stress Management for Headaches

• 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

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Stress Reduction	Mindfulness Based Stress Reduction	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.
Stress Management for Headaches	Stress Management for Headaches	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.

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)

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

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