Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Lucy Chen, M.D.
llchen@mgh.harvard.edu
617-724-3466
Backup
Jianren Mao, M.D.
jmao@mgh.harvard.edu
617-726-2338
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov