taVNS Treatment for Fibromyalgia (NCT04777500) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
taVNS Treatment for Fibromyalgia
United States60 participantsStarted 2026-10-03
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.