- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02133209
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
Status
Completed
Conditions
Intervention / Treatment
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
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland School of Dentistry
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Baltimore, Maryland, United States, 21224
- Johns Hopkins University, Bayview Medical Campus
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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.
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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.
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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
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Headache days per 28 days and headache-related disability (HIT-6)
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Baseline, 3, 6, and 12 months
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Change in gray matter volume
Time Frame: Baseline, 3, and 6 months
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Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate
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Baseline, 3, and 6 months
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Change in Brain Function
Time Frame: Baseline, 3, and 6 months
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Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula
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Baseline, 3, and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in headache intensity
Time Frame: Baseline, 3, 6, and 12 months
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Change in headache intensity
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Baseline, 3, 6, and 12 months
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Change in Brain Structure
Time Frame: Baseline, 3, and 6 months
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Gray matter volume and white matter tracts across the whole brain
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Baseline, 3, and 6 months
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Change in Whole Brain Function
Time Frame: Baseline, 3, and 6 months
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Cognitive-related activity, pain-related activity, and resting state across the whole brain
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Baseline, 3, and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
General Publications
- Burrowes SAB, Goloubeva O, Keaser ML, Haythornthwaite JA, Seminowicz DA. Differences in gray matter volume in episodic migraine patients with and without prior diagnosis or clinical care: a cross-sectional study. J Headache Pain. 2021 Oct 23;22(1):127. doi: 10.1186/s10194-021-01340-5.
- Burrowes SAB, Goloubeva O, Stafford K, McArdle PF, Goyal M, Peterlin BL, Haythornthwaite JA, Seminowicz DA. Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial. Pain. 2022 Mar 1;163(3):436-444. doi: 10.1097/j.pain.0000000000002372.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00091884
- R01AT007176 (U.S. NIH Grant/Contract)
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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