Vagus Nerve Stimulation and Stress Reduction Training for Migraine
NCT ID: NCT03592329
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
193 participants
INTERVENTIONAL
2019-08-20
2025-05-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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active tVNS + SRT A
active tVNS and Stress Reduction Training A
Stress Reduction Training A
twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
active tVNS
non-painful electrical stimulation of the auricle
active tVNS + SRT B
active tVNS and Stress Reduction Training B
active tVNS
non-painful electrical stimulation of the auricle
Stress Reduction Training B
twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
sham tVNS + SRT A
sham stimulation and Stress Reduction Training A
Stress Reduction Training A
twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
sham tVNS
sham stimulation
sham tVNS + SRT B
sham tVNS and Stress Reduction Training B
Stress Reduction Training B
twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
sham tVNS
sham stimulation
Interventions
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Stress Reduction Training A
twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
active tVNS
non-painful electrical stimulation of the auricle
Stress Reduction Training B
twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
sham tVNS
sham stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Migraine Diagnosis and general health otherwise.
3. Willingness to attend twice- weekly treatment session at Cambridge Health Alliance for 8 weeks.
4. Able to give written consent and participate in group interventions in English.
Healthy Volunteers between the ages of 18 and 65 can participate in this study.
Exclusion Criteria
2. Previous experience with stress reduction training (such as mindfulness training, MBSR, MBCT, Relaxation Response) or more than 15 home mediation practice sessions in the past month, or more than 10 classes in yoga, Tai Chi, or Qi Gong in the past 3 months
3. Any condition that would prohibit MRI scanning
Healthy Volunteers have the same eligibility constraints with the addition of current or past history of migraine.
18 Years
65 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Vitaly Napadow, Ph.D., Lic.Ac.
Associate Professor
Principal Investigators
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Vitaly Napadow, PhD,Lic.Ac.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Anthinoula A. Martinos Center
Charlestown, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2018P001184
Identifier Type: -
Identifier Source: org_study_id
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