taVNS Treatment for Fibromyalgia

This study is looking into whether a device called auricular transcutaneous electrical nerve stimulation (taVNS) can help relieve chronic pain for people with fibromyalgia. taVNS is a safe electrical stimulation tool. We plan to enroll 60 people with fibromyalgia who are between 18 and 65 years old. To join, you need to meet specific criteria for fibromyalgia and be willing to complete treatments twice a day for four weeks. The main goal is to see if taVNS improves your fibromyalgia symptoms, which will be measured using a questionnaire called the Revised Fibromyalgia Impact Questionnaire (FIQR) at the start, after two weeks, and after four weeks. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 60 participants with fibromyalgia.
What's involved
You would complete treatments twice a day for four weeks. You would also complete a questionnaire at the start, after two weeks, and after four weeks.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be measured at baseline, week 2, and week 4.

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NCT04777500

taVNS Treatment for Fibromyalgia

Not Yet Recruiting
NAAges 18–65InterventionalTreatment
Massachusetts General Hospital
~60 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Auricular transcutaneous electrical nerve stimulation device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Revised Fibromyalgia Impact Questionnaire (FIQR)
Measured over Baseline, week 2 and week 4.
Fibromyalgia
1 sites across 1 states
Massachusetts1
  • Jian Kong · PRINCIPAL_INVESTIGATOR · MGH

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Revised Fibromyalgia Impact Questionnaire (FIQR)Baseline, week 2 and week 4.

    A change in the FIQR would indicate that participants are experiencing pain relief.