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Vagus Nerve Stimulation and Stress Reduction Training for Migraine

NCT03592329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2026-02-25

Study results available
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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

Interventions

BEHAVIORAL

Stress Reduction Training A

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

DEVICE

active tVNS

non-painful electrical stimulation of the auricle

BEHAVIORAL

Stress Reduction Training B

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

DEVICE

sham tVNS

sham stimulation

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Vitaly Napadow, PhD,Lic.Ac. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2025-01-14
Completion
2025-05-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03592329 on ClinicalTrials.gov