Vagus Nerve Stimulation and Stress Reduction Training for Migraine

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03592329
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Stress Reduction Training A — BEHAVIORAL
    twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
  • active tVNS — DEVICE
    non-painful electrical stimulation of the auricle
  • Stress Reduction Training B — BEHAVIORAL
    twice weekly "booster" sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions
  • sham tVNS — DEVICE
    sham stimulation

Study Details

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.

Key Dates

Start date
Aug 20, 2019
Status verified
Feb 2026
Primary completion
Jan 14, 2025
Completion
May 29, 2025

Study Design

Enrollment
193 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: active tVNS + SRT A
    active tVNS and Stress Reduction Training A
  • Experimental: active tVNS + SRT B
    active tVNS and Stress Reduction Training B
  • Other: sham tVNS + SRT A
    sham stimulation and Stress Reduction Training A
  • Other: sham tVNS + SRT B
    sham tVNS and Stress Reduction Training B

Primary Outcome Measure

Brain Activity Changes in Migraine Patients in Response to Treatment [ Time Frame: 8 weeks (i.e. post-treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Anthinoula A. Martinos CenterCharlestownMassachusetts02129-

Find similar trials in Charlestown, MA

By condition
Migraine
By specialty
Neurology
By research site
Anthinoula A. Martinos Center· Charlestown, MA

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