Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- 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
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
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.No longer taking part
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07904351, who can take part
- Record updated
- 2 November 2026