Vagus Nerve Stimulation and Stress Reduction Training for Migraine

NCT03592329 | Completed Results DMC

• 2 other identifiers: 2018P001184P01AT009965
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Brain Activity Changes in Migraine Patients in Response to Treatment

  Post-treatment versus baseline change in intervention-evoked cortical amplification ratio (left posterior insula to spinal trigeminal nucleus ratio of fMRI BOLD percent signal change) for trigeminal afferent stimulation (i.e. forehead stimulation).

  8 weeks (i.e. post-treatment)

• Brain Inflammation Changes in Migraine Patients in Response to Treatment

  PET \[11C\]PBR28 signal, quantified as Standardized Uptake Value Ratio (SUVR; i.e., tissue radioactivity / injected dose / weight) change from baseline to post-treatment, compared across treatment groups for migraine patients. \[11C\]PBR28 SUVR was measured in the insula (average of left and right insula), using cerebellum SUV as a pseudo-reference region.

  8 weeks (post-treatment)

Secondary Outcomes (2)

• Brain Activity Differences Between Migraine Patients and Healthy Controls

  Week 0-3 (Baseline window)

• Brain Inflammation Differences Between Migraine Patients and Healthy Controls

  Week 0-3 (Baseline window)

Other Outcomes (2)

• Primary Clinical Outcome (HIT6)

  8 weeks (post-treatment)

• Secondary Clinical Outcome (PCS)

  8 weeks (post-treatment)

Study Arms (4)

active tVNS + SRT A

EXPERIMENTAL

active tVNS and Stress Reduction Training A

Behavioral: Stress Reduction Training A; Device: active tVNS

active tVNS + SRT B

EXPERIMENTAL

active tVNS and Stress Reduction Training B

Device: active tVNS; Behavioral: Stress Reduction Training B

sham tVNS + SRT A

OTHER

sham stimulation and Stress Reduction Training A

Behavioral: Stress Reduction Training A; Device: sham tVNS

sham tVNS + SRT B

OTHER

sham tVNS and Stress Reduction Training B

Behavioral: Stress Reduction Training B; Device: sham tVNS

Interventions

Stress Reduction Training A BEHAVIORAL

twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions

Also known as: SRT A

active tVNS + SRT A; sham tVNS + SRT A

active tVNS DEVICE

non-painful electrical stimulation of the auricle

Also known as: transcutaneous vagus nerve stimulation

active tVNS + SRT A; active tVNS + SRT B

Stress Reduction Training B BEHAVIORAL

twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions

Also known as: SRT B

active tVNS + SRT B; sham tVNS + SRT B

sham tVNS DEVICE

sham stimulation

sham tVNS + SRT A; sham tVNS + SRT B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Anthinoula A. Martinos Center

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Vitaly Napadow
• Organization: Spaulding Rehabilitation Hospital

vitaly@mgh.harvard.edu

617-952-6480

Study Officials

• Vitaly Napadow, PhD,Lic.Ac.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: July 19, 2018
• Study Start: August 20, 2019
• Primary Completion: January 14, 2025
• Study Completion: May 29, 2025
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2026-02

Locations

US (1)