Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

NCT06009159 | Recruiting FDA Device

• 1 other identifier: 2023P001211
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Vagus nerve stimulation,; pain; fibromyalgia symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Multidimensional Fatigue Inventory

  at 0,4,8 weeks of the study

• Medical Outcomes Study Sleep Scale

  at 0,4,8 weeks of the study

• Revised Fibromyalgia Impact Questionnaire

  at 0,4,8 weeks of the study

• Medical Outcomes Study Questionnaire Short Form 36

  at 0, 4, 8 weeks of the study

• Blood inflammation marker

  at 0, 4, 8 weeks of the study

Study Arms (2)

Transcutaneous Vagus Nerve Stimulation(tVNS)

EXPERIMENTAL

receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.

Device: Transcutaneous Vagus Nerve Stimulation

Sham Control group

NO INTERVENTION

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 DEVICE

30 minutes stimulation, twice per day for 4 weeks

Transcutaneous Vagus Nerve Stimulation(tVNS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 to 80 years old, including both male and female subjects.
• 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.
• Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).

You may not qualify if:

• Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
• Subject has major psychiatric disorder required hospitalization in the last 3 months.
• Subject has active infection at the site of device application.
• Subject has recurrent syncope symptoms within the past three months.
• Subject is pregnant.
• Subject has had VNS treatment within the past two months.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 31637517 BACKGROUND

• 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.

  PMID: 26364692 BACKGROUND

• 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.

  PMID: 33114203 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lucy Chen, M.D.

CONTACT

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

Jianren Mao, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 4-week of clinical study with a total of 60 subjects, randomized into 2 groups (30 subjects in tVNS and 30 subjects in control group )

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 24, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)