Recruiting

VNS

Sponsor:

Massachusetts General Hospital

Code:

NCT06009159

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Vagus Nerve Stimulation

Study Details

Brief 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.

Conditions

Fibromyalgia

Study ID

NCT06009159

Start date

Jul 1, 2024

Status verified date

May, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).

Exclusion Criteria:

1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
2. Subject has major psychiatric disorder required hospitalization in the last 3 months.
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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Transcutaneous Vagus Nerve Stimulation

30 minutes stimulation, twice per day for 4 weeks

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lucy Chen, M.D.

617-724-3466llchen@mgh.harvard.edu

Jianren Mao, M.D.

617-726-2338jmao@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Lucy Chen, M.D.

617-724-6102llchen@mgh.harvard.edu

Jianren Mao, M.D.

617-724-6102jmao@mgh.harvard.edu

Principal Investigator:

Lucy Chen, M.D.

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 6, 2025

Last verified

May, 2025

Keywords

  • Vagus nerve stimulation,
  • pain
  • fibromyalgia symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-05-06.