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Ear nerve stimulation device for pain in fibromyalgia

Tests a small ear device for pain control in people with fibromyalgia.

Key facts

Who runs it
Spaulding Rehabilitation Hospital
Where
Cambridge, United StatesSee the site
Trial code
Registry title
Effects of taVNS on Fibromyalgia Pain
Status
Not yet recruiting
People taking part
152 people, planned
Started
1 Jun 2026
Expected to end
1 May 2029
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Transauricular vagus nerve stimulation (taVNS)
Record updated
19 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with fibromyalgia pain. It tests whether ear stimulation of the vagus nerve (taVNS) helps control pain.

Age
Older than 18 years.
Sex
All sexes can join.
Disease stage
Fibromyalgia diagnosed by the American College of Rheumatology (ACR) 2010 criteria. Pain for more than six months, with an average of at least 3 on a 0-10 scale.

Main reasons for not taking part

  • Unstable health problems, such as uncontrolled diabetes, heart failure or chronic obstructive pulmonary disease, or functional deficits
  • Substance abuse in the past six months
  • Electronic devices implanted in the head, such as cochlear implants
  • Pregnancy
  • Not able to feel touch from a Von-Frey fiber test on the forearm

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Older than 18 years old
  • 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)
  • must have the ability to feel sensation by Von-Frey fiber on the forearm
  • Able to provide informed consent to participate in the study

Who cannot take part

  • Presence of implanted cranial electronic medical devices (e.g., cochlear implants)
  • 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
  • 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)
  • 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)

Where in United States

  • Spaulding Hospital CambridgeCambridge, United StatesContact: Felipe Fregni, MD, PhD, MPHNot yet recruiting

About the trial

What the trial wants to find out

Transauricular vagus nerve stimulation (taVNS) is a newer delivery system, using a non-invasive stimulation device placed at the ear's concha. TaVNS is a portable, safe, and low-cost intervention, and according to some studies, taVNS may influence nociception and pain perception, which can lead to potential applications for various painful illnesses, including fibromyalgia (FM). This trial aims to investigate the clinical effects of taVNS on pain control in FM subjects.

The 2 groups in the trial

  • Active taVNSTreatment being tested

    TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hertz (Hz), 200-250 us, and with adjustable intensity for 60 min for 16 sessions.

    Treatment: Transauricular vagus nerve stimulation (taVNS)

  • Sham taVNSSham treatment, for comparison

    Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min for 16 sessions there will be no current and the device will be turned off.

    Treatment: Transauricular vagus nerve stimulation (taVNS)

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
Effects of taVNS on Fibromyalgia Pain
Plain-language title
Ear nerve stimulation device for pain in fibromyalgiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
19 September 2025