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taVNS Treatment for Fibromyalgia

Key facts

Who runs it
Massachusetts General Hospital
Where
Charlestown, United StatesSee the site
Trial code
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

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

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 EshelNo longer taking part

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

  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
Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia
Fit questions
Built from NCT04777500, who can take part
Record updated
17 April 2026