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MRI Outcomes of Mindfulness Meditation for Migraine

MRI Outcomes of Mindfulness Meditation for Migraine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02133209
Enrollment
98
Registered
2014-05-07
Start date
2014-05-31
Completion date
2018-03-31
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

migraine, headache, meditation, mindfulness based stress reduction, MBSR

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.

Interventions

BEHAVIORALMindfulness 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.

BEHAVIORALStress 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.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of Maryland
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in headache frequency and impactBaseline, 3, 6, and 12 monthsHeadache days per 28 days and headache-related disability (HIT-6)
Change in gray matter volumeBaseline, 3, and 6 monthsGray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate
Change in Brain FunctionBaseline, 3, and 6 monthsOverall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula

Secondary

MeasureTime frameDescription
Change in headache intensityBaseline, 3, 6, and 12 monthsChange in headache intensity
Change in Brain StructureBaseline, 3, and 6 monthsGray matter volume and white matter tracts across the whole brain
Change in Whole Brain FunctionBaseline, 3, and 6 monthsCognitive-related activity, pain-related activity, and resting state across the whole brain

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026