Clinical trial NCT02133209: MRI Outcomes of Mindfulness Meditation for Migraine
Official title: MRI Outcomes of Mindfulness Meditation for Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine
headache
meditation
mindfulness based stress reduction
MBSR
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of Maryland
First posted: 2014-05-07
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in headache frequency and impact
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in gray matter volume
timeFrame: Baseline, 3, and 6 months
measure: Change in Brain Function
timeFrame: Baseline, 3, and 6 months
Secondary outcomes:
measure: Change in headache intensity
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Brain Structure
timeFrame: Baseline, 3, and 6 months
measure: Change in Whole Brain Function
timeFrame: Baseline, 3, and 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University, Bayview Medical Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jennifer A Haythornthwaite, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Maryland
name: David Seminowicz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.