Ear nerve stimulation for pain in people with fibromyalgia
Tests gentle electrical stimulation of the ear for fibromyalgia pain in adults.
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Charlestown, United StatesSee the site
- Trial code
- Registry title
- taVNS Treatment for Fibromyalgia
- Status
- Not yet recruiting
- People taking part
- 60 people, planned
- Started
- 3 Oct 2026
- Expected to end
- Mar 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Auricular transcutaneous electrical nerve stimulation device
- Record updated
- 17 April 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. It tests whether gentle electrical stimulation of a nerve through the ear can ease fibromyalgia pain.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Disease stage
- Fibromyalgia confirmed by clinicians using the ACR 1990 classification criteria and the ACR 2010 diagnostic criteria.
Main reasons for not taking part
- Conditions that can cause fibromyalgia-like symptoms, such as thyroid disease, lupus, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome
- Heart, breathing or nervous system disease that the study doctor judges too risky, such as asthma or claustrophobia
- Past medical or mental illness, as judged by the study doctor
- Being pregnant or breastfeeding
- Reading English below a 10th grade level, or being unable to understand the study questions
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians
- Willingness to complete a 4-week, twice-a-day treatments
- At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures
Who cannot take part
- Diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia
- Personal history of medical or psychiatric illness as determined by investigator
- Pregnant or lactating
- Less than a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures
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 65 years old?
Where in United States
- Massachusetts General HospitalCharlestown, United StatesContact: Maya EshelNot yet recruiting
About the trial
What the trial wants to find out
In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.
The 2 groups in the trial
- taVNS Group1Treatment being tested
This group will receive taVNS for 4 weeks.
Treatment: Auricular transcutaneous electrical nerve stimulation device
- taVNS Group 2Treatment being tested
This group will receive taVNS for 4 weeks.
Treatment: Auricular transcutaneous electrical nerve stimulation device
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.
- Official title
- Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia
- Plain-language title
- Ear nerve stimulation for pain in people with fibromyalgiaGenerated 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 NCT04777500, who can take part
- Record updated
- 17 April 2026