MRI Outcomes of Mindfulness Meditation for Migraine

August 7, 2018 updated by: Johns Hopkins University
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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Dentistry
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University, Bayview Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in headache frequency and impact
Time Frame: Baseline, 3, 6, and 12 months
Headache days per 28 days and headache-related disability (HIT-6)
Baseline, 3, 6, and 12 months
Change in gray matter volume
Time Frame: Baseline, 3, and 6 months
Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate
Baseline, 3, and 6 months
Change in Brain Function
Time Frame: 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
Baseline, 3, and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jennifer A Haythornthwaite, Ph.D., Johns Hopkins University
  • Principal Investigator: David Seminowicz, Ph.D., University of Maryland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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