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MRI Outcomes of Mindfulness Meditation for Migraine

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ClinicalTrials.gov Identifier: NCT02133209
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
University of Maryland
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Behavioral: Mindfulness Based Stress Reduction Behavioral: Stress Management for Headaches Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MRI Outcomes of Mindfulness Meditation for Migraine
Actual Study Start Date : May 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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.
Behavioral: Stress Management for 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.
Behavioral: Mindfulness Based Stress Reduction
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.




Primary Outcome Measures :
  1. 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)

  2. Change in gray matter volume [ Time Frame: Baseline, 3, and 6 months ]
    Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate

  3. 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


Secondary Outcome Measures :
  1. Change in headache intensity [ Time Frame: Baseline, 3, 6, and 12 months ]
    Change in headache intensity

  2. Change in Brain Structure [ Time Frame: Baseline, 3, and 6 months ]
    Gray matter volume and white matter tracts across the whole brain

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133209


Locations
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United States, Maryland
University of Maryland School of Dentistry
Baltimore, Maryland, United States, 21201
Johns Hopkins University, Bayview Medical Campus
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Center for Complementary and Integrative Health (NCCIH)
University of Maryland
Investigators
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Study Director: Jennifer A Haythornthwaite, Ph.D. Johns Hopkins University
Principal Investigator: David Seminowicz, Ph.D. University of Maryland

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02133209     History of Changes
Other Study ID Numbers: NA_00091884
R01AT007176 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by Johns Hopkins University:
migraine
headache
meditation
mindfulness based stress reduction
MBSR

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases