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Brain Mechanisms of Vagus Nerve Stimulation and Stress Reduction Training for Migraine
This study design has two components: 1) a cross-sectional assessment of brain activity and inflammation in migraine patients compared to healthy controls and 2) an assessment of 8 weeks of a combination therapy approach to treating migraine.
Chronic pain is the most prevalent and disabling medical condition, and no single therapy has proven to be completely successful for alleviating pain, such as migraine headache. It is well documented, and recommended in the recent Institute of Medicine (IOM) report, that a multimodal approach is optimal for pain management. This study will evaluate a combination transcutaneous vagus nerve stimulation and stress reduction training for migraine. Investigators will recruit participants who have migraines and randomize to one of four potential treatment arms (real or sham stimulation + real or sham stress reduction training). Brain imaging (MRI and PET) and clinical data will be collected before and after 8 weeks of the combination therapy. Healthy controls will also be recruited for collection of the same baseline brain imaging and clinical data, but with no treatment or second data collection phase. Findings from this research will help elucidate brain activity and inflammation associated with migraines and evaluate the efficacy of the combination therapy in reducing migraine.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Anthinoula A. Martinos Center
Charlestown, Massachusetts, United States
Start Date
August 20, 2019
Primary Completion Date
January 14, 2025
Completion Date
May 29, 2025
Last Updated
February 25, 2026
193
ACTUAL participants
Stress Reduction Training A
BEHAVIORAL
active tVNS
DEVICE
Stress Reduction Training B
BEHAVIORAL
sham tVNS
DEVICE
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT06641466
NCT07018713
NCT04715685
Data Source & Attribution
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