taVNS Treatment for Fibromyalgia

Last updated: June 1, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

Auricular transcutaneous electrical nerve stimulation device

Clinical Study ID

NCT04777500
2020P003800
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the American College of Rheumatology (ACR) 1990 classification criteria and theACR 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 languageprovided that the patients understand all questions used in the assessment measures.

Exclusion

Exclusion Criteria:

  • Diagnosed with medical conditions that are known to contribute to fibromyalgiasymptomatology, such as thyroid disease, inflammatory arthritis, systemic lupuserythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome.

  • History of cardiac, respiratory, or nervous system disease that, in theinvestigator's judgment, precludes participation in the study because of aheightened 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 languageprovided that the patients understand all questions used in the assessment measures.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Auricular transcutaneous electrical nerve stimulation device
Phase:
Study Start date:
January 03, 2026
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Massachusetts General Hospital

    Charlestown, Massachusetts 02129-2020
    United States

    Site Not Available

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