MRI Outcomes of Mindfulness Meditation for Migraine
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/10/2018 |
| Start Date: | May 2014 |
| End Date: | March 2018 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Baltimore, Maryland 21201
Principal Investigator: David A. Seminowicz, Ph.D.
Phone: 410-706-4049
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Baltimore, Maryland 21224
Principal Investigator: Jennifer A Haythornthwaite, Ph.D.
Phone: 410-550-9056
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