Actively Recruiting
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Led by Massachusetts General Hospital · Updated on 2025-05-06
60
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, male or female
- Diagnosed with fibromyalgia for at least three months
- Pain score of 4 or higher on a 0 to 10 scale
You will not qualify if you...
- Current cardiac arrhythmia or implanted pacemaker or AICD device
- Major psychiatric disorder requiring hospitalization in the last 3 months
- Active infection at the device application site
- Recurrent fainting episodes within the past 3 months
- Pregnancy
- Received VNS treatment in the past 2 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Lucy Chen, M.D.
CONTACT
J
Jianren Mao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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