Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Last updated: May 5, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

Transcutaneous Vagus Nerve Stimulation

Clinical Study ID

NCT06009159
2023P001211
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is 18 to 80 years old, including both male and female subjects.

  2. Subject has a documented diagnosis of FM for at least three months. This requirementis to avoid the uncertainty of an unstable pain condition and to minimize the studyvariation.

  3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain toworst pain).

Exclusion

Exclusion Criteria:

  1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICDdevice.

  2. Subject has major psychiatric disorder required hospitalization in the last 3months.

  3. Subject has active infection at the site of device application.

  4. Subject has recurrent syncope symptoms within the past three months.

  5. Subject is pregnant.

  6. Subject has had VNS treatment within the past two months.

.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Transcutaneous Vagus Nerve Stimulation
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
October 31, 2026

Study Description

The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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