Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 8-week crossover clinical study with 30 subjects (tVNS vs. control; crossover to control vs. tVNS; 4 weeks per period). 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), after first 4 weeks of tVNS treatment or control before crossover, and at the end of the entire study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06009159
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Lucy Chen, M.D.
Phone	617-724-3466
Email	llchen@mgh.harvard.edu
Status	Not yet recruiting
Phase	N/A
Start date	August 1, 2024
Completion date	December 31, 2025

View Details

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