Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Recruiting now · Not applicable

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT06009159

Run by

Massachusetts General Hospital

People needed

60

Starts

2024-07-01

Expected to finish

2026-10-31

Last updated by the study team

2025-05-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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