MRI Outcomes of Mindfulness Meditation for Migraine

Migraine Clinical Trial

Official title:

MRI Outcomes of Mindfulness Meditation for Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133209
• Other study ID #: NA_00091884
• Secondary ID: R01AT007176
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Mindfulness 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.
• Stress 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University, Bayview Medical Campus	Baltimore	Maryland
United States	University of Maryland School of Dentistry	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Center for Complementary and Integrative Health (NCCIH), University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in headache frequency and impact	Headache days per 28 days and headache-related disability (HIT-6)	Baseline, 3, 6, and 12 months
Primary	Change in gray matter volume	Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate	Baseline, 3, and 6 months
Primary	Change in Brain Function	Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula	Baseline, 3, and 6 months
Secondary	Change in headache intensity	Change in headache intensity	Baseline, 3, 6, and 12 months
Secondary	Change in Brain Structure	Gray matter volume and white matter tracts across the whole brain	Baseline, 3, and 6 months
Secondary	Change in Whole Brain Function	Cognitive-related activity, pain-related activity, and resting state across the whole brain	Baseline, 3, and 6 months