Taking people in United StatesNo phase

Vagus nerve stimulation through the skin for fibromyalgia

Tests vagus nerve stimulation through the skin in people with fibromyalgia.

Key facts

Who runs it: Massachusetts General Hospital
Where: Boston, United StatesSee the site
Trial code: NCT06009159
Registry title: Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Status: Recruiting
People taking part: 60 people, planned
Started: 1 Jul 2024
Expected to end: 31 Oct 2029
Type of study: Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested: Transcutaneous Vagus Nerve Stimulation
Record updated: 14 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with fibromyalgia who have ongoing pain. It tests stimulation of the vagus nerve through the skin.

Age: 18 to 80 years
Sex: Male and female
Disease stage: A documented diagnosis of fibromyalgia for at least three months. Pain score of 4 or above on a 0 - 10 scale.
Earlier treatment: No VNS treatment within the past two months.

Main reasons for not taking part

Current irregular heartbeat (cardiac arrhythmia), or an implanted pacemaker or AICD device
Major mental health disorder that needed a hospital stay in the last 3 months
Active infection where the device is placed
Repeated fainting within the past three months
Pregnancy

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

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)

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in United States

Massachusetts General HospitalBoston, United StatesContact: Lucy Chen, M.D.Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

Transcutaneous Vagus Nerve Stimulation(tVNS)Treatment being tested
receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.
Treatment: Transcutaneous Vagus Nerve Stimulation
Sham Control groupNo study treatment, for comparison
receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.