Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06009159
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Vagus Nerve Stimulation — DEVICE
    30 minutes stimulation, twice per day for 4 weeks

Study Details

Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.

Key Dates

Start date
Jul 1, 2024
Status verified
May 2025
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcutaneous Vagus Nerve Stimulation(tVNS)
    receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.
  • No Intervention: Sham Control group
    receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.

Primary Outcome Measure

A modified McGill Pain Questionnaire [ Time Frame: at 0,4, weeks of the study, ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Lucy Chen, M.D.
[email protected]
617-724-6102
Jianren Mao, M.D.
[email protected]
617-724-6102
Lucy Chen, M.D. (PRINCIPAL_INVESTIGATOR)

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