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MRI Outcomes of Mindfulness Meditation for Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Stress Management for Headaches
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, headache, meditation, mindfulness based stress reduction, MBSR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland School of Dentistry
  • Johns Hopkins University, Bayview Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stress Management for Headaches

Mindfulness Based Stress Reduction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in headache frequency and impact
Headache days per 28 days and headache-related disability (HIT-6)
Change in gray matter volume
Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate
Change in Brain Function
Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula

Secondary Outcome Measures

Change in headache intensity
Change in headache intensity
Change in Brain Structure
Gray matter volume and white matter tracts across the whole brain
Change in Whole Brain Function
Cognitive-related activity, pain-related activity, and resting state across the whole brain

Full Information

First Posted
April 21, 2014
Last Updated
August 7, 2018
Sponsor
Johns Hopkins University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of Maryland
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1. Study Identification

Unique Protocol Identification Number
NCT02133209
Brief Title
MRI Outcomes of Mindfulness Meditation for Migraine
Official Title
MRI Outcomes of Mindfulness Meditation for Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of Maryland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, headache, meditation, mindfulness based stress reduction, MBSR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress Management for Headaches
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mindfulness Based Stress Reduction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management for Headaches
Intervention Description
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 Outcome Measure Information:
Title
Change in headache frequency and impact
Description
Headache days per 28 days and headache-related disability (HIT-6)
Time Frame
Baseline, 3, 6, and 12 months
Title
Change in gray matter volume
Description
Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate
Time Frame
Baseline, 3, and 6 months
Title
Change in Brain Function
Description
Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula
Time Frame
Baseline, 3, and 6 months
Secondary Outcome Measure Information:
Title
Change in headache intensity
Description
Change in headache intensity
Time Frame
Baseline, 3, 6, and 12 months
Title
Change in Brain Structure
Description
Gray matter volume and white matter tracts across the whole brain
Time Frame
Baseline, 3, and 6 months
Title
Change in Whole Brain Function
Description
Cognitive-related activity, pain-related activity, and resting state across the whole brain
Time Frame
Baseline, 3, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Haythornthwaite, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Seminowicz, Ph.D.
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Dentistry
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University, Bayview Medical Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34688253
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.
Results Reference
derived
PubMed Identifier
34407032
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. Erratum In: Pain. 2023 Feb 1;164(2):e120.
Results Reference
derived

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MRI Outcomes of Mindfulness Meditation for Migraine

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