Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Transcutaneous Vagus Nerve Stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucy Chen, M.D.; Phone Number: 617-724-3466; Email: llchen@mgh.harvard.edu
• Study Contact Backup: Name: Jianren Mao, M.D.; Phone Number: 617-726-2338; Email: jmao@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Lucy Chen, M.D.; Phone Number: 617-724-6102; Email: llchen@mgh.harvard.edu
      • Contact: Jianren Mao, M.D.; Phone Number: 617-724-6102; Email: jmao@mgh.harvard.edu
      • Principal Investigator: Lucy Chen, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Vagus Nerve Stimulation(tVNS); receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.	Device: Transcutaneous Vagus Nerve Stimulation; 30 minutes stimulation, twice per day for 4 weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A modified McGill Pain Questionnaire	Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain	at 0,4, weeks of the study,

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional Fatigue Inventory	Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.	at 0,4,8 weeks of the study
Medical Outcomes Study Sleep Scale	sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time	at 0,4,8 weeks of the study
Revised Fibromyalgia Impact Questionnaire	Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact	at 0,4,8 weeks of the study
Medical Outcomes Study Questionnaire Short Form 36	Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.	at 0, 4, 8 weeks of the study
Blood inflammation marker	collect blood sample for cytokines level	at 0, 4, 8 weeks of the study
Assessment of gut microbiome changes through genomic phenotypic	collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome	at 0, 4, 8 weeks of the study

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14.
• Moisset X, Lanteri-Minet M, Fontaine D. Neurostimulation methods in the treatment of chronic pain. J Neural Transm (Vienna). 2020 Apr;127(4):673-686. doi: 10.1007/s00702-019-02092-y. Epub 2019 Oct 21.
• Maffei ME. Fibromyalgia: Recent Advances in Diagnosis, Classification, Pharmacotherapy and Alternative Remedies. Int J Mol Sci. 2020 Oct 23;21(21):7877. doi: 10.3390/ijms21217877.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: pain; Vagus nerve stimulation,; fibromyalgia symptoms
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2023P001211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No