N/A
N=136
Vagus Nerve Stimulation and Stress Reduction Training for Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03592329 ↗Enrolled (actual)
136
Serious AEs
1.5%
Results posted
Feb 2026
Primary outcome: Primary: Brain Activity Changes in Migraine Patients in Response to Treatment — -0.249; 0.679; 0.680; 1.06 Log ratio % signal change (Insula/Sp5)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stress Reduction Training A (Behavioral); active tVNS (Device); Stress Reduction Training B (Behavioral); sham tVNS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Activity Changes in Migraine Patients in Response to Treatment |
-0.249; 0.679; 0.680; 1.06 | — |
| PRIMARY Brain Inflammation Changes in Migraine Patients in Response to Treatment |
-0.00668; -0.0113; 0.0590; -0.0234 | — |
| SECONDARY Brain Activity Differences Between Migraine Patients and Healthy Controls |
-0.114; 0.0146 | — |
| SECONDARY Brain Inflammation Differences Between Migraine Patients and Healthy Controls |
0.974; 0.989 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects must be between 18 and 65 years of age.
- Migraine Diagnosis and general health otherwise.
- Willingness to attend twice- weekly treatment session at Cambridge Health Alliance for 8 weeks.
- 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
- Major illness, psychiatric condition, or neurological disease.
- 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
- Any condition that would prohibit MRI scanning
Healthy Volunteers have the same eligibility constraints with the addition of current or past history of migraine.
Data sourced from ClinicalTrials.gov (NCT03592329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.