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Vagus nerve stimulation through the skin for fibromyalgia pain and symptoms

Tests a skin-based vagus nerve stimulation device in adults with fibromyalgia.

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Status
Not yet recruiting
People taking part
105 people, planned
Started
15 Oct 2026
Expected to end
31 Aug 2029
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Transcutaneous Vagus Nerve Stimulation
Record updated
2 November 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 and ongoing pain. It tests a skin-worn vagus nerve stimulation device (VagaCalm) against a sham device.

Age
18 to 80 years
Sex
Men and women can join.
Disease stage
A documented fibromyalgia diagnosis for at least three months, with a pain score of 4 or above on a 0 - 10 scale.
Earlier treatment
No VNS (vagus nerve stimulation) 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 illness 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: Melissa Difuntorum, B.S.Not yet recruiting

About the trial

What the trial wants to find out

Fibromyalgia is a syndrome with clinical symptoms that affect multiple systems of the body. Although basic science research and clinical research trials have been carried out, the cause and the mechanism of fibromyalgia are still unknown. The goal of current medical treatment is to relieve symptoms and improve quality of life. Recent clinical and experimental studies have shown that stimulation of the vagus nerve has a potential to help pain syndromes. In this study, we aim to evaluate the effects of using transcutaneous vagus nerve stimulation (tVNS) on treating pain and other symptoms in fibromyalgia patients. We will do this by using the VagaCalm device.

The 2 groups in the trial

  • Transcutaneous Vagus Nerve Stimulation (tVNS)Treatment being tested

    Receive tVNS 30 minutes per session, twice/day for 6 weeks and maintain regular medication treatment without change. Post study follow up will occur 2 weeks after completing the 6-week treatment.

    Treatment: Transcutaneous Vagus Nerve Stimulation

  • Sham Control GroupNo study treatment, for comparison

    Receive sham point stimulation 30 minutes per session, twice/day for 6 weeks and maintain regular medication treatment without change. Post study follow up will occur 2 weeks after completing the 6-week treatment.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Plain-language title
Vagus nerve stimulation through the skin for fibromyalgia pain and symptomsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07904351, who can take part
Record updated
2 November 2026