What this study is
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.
What's being tested
- Transcutaneous Vagus Nerve Stimulation
Intervention · DEVICE
30 minutes stimulation, twice per day for 4 weeks
Study details
- Sponsor
- Massachusetts General Hospital
- Conditions
- Fibromyalgia
- Enrolling
- 60 people
- Starts
- 2024-07-01
- Est. completion
- 2029-10-31
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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. .
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Lucy Chen, M.D. · Contact617-724-6102llchen@mgh.harvard.edu
- Jianren Mao, M.D. · Contact617-724-6102jmao@mgh.harvard.edu
- Lucy Chen, M.D. · Principal investigator
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2023P001211
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.