Could a simple ear device ease fibromyalgia pain?
NCT ID NCT06193317
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a non-invasive device that gently stimulates the vagus nerve through the ear to see if it can reduce pain in people with fibromyalgia. Researchers will enroll 152 adults with fibromyalgia to measure changes in pain severity. The approach is portable, safe, and low-cost, offering a potential drug-free option for pain management.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transauricular vagus nerve stimulation (taVNS) device
- What this could lead to
- If it works, this could offer a safe, low-cost, non-invasive option for managing fibromyalgia pain without drugs.
- What could go wrong
- This is an early-stage trial with no results yet. The device may not reduce pain significantly, and individual responses can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 152 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Older than 18 years old. 2. Diagnosis of FM pain according to the American College of Rheumatology (ACR) 2010 criteria (existing pain for more than six months with an average of at least 3 on a 0-10 VAS scale). 3. must have the ability to feel sensation by Von-Frey fiber on the forearm. 4. Able to provide informed consent to participate in the study. Exclusion Criteria: 1. Subjects who have unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease) or who have functional deficits, as self-reported. 2. history of substance abuse within the past six months as self-reported (if the subject reports a history of substance abuse, we will confirm using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria). 3. Presence of implanted cranial electronic medical devices (e.g., cochlear implants). 4. pregnancy (as the safety of taVNS in the pregnant population (and children) has not been assessed (though the risk is non-significant), we will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and every two weeks of stimulation).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138, United States