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Completed

NCT Number: NCT02133209

MRI Outcomes of Mindfulness Meditation for Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Bayview Medical Campus, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

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.

Stress Management for Headaches

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Maryland

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 7, 2014
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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