Effects of taVNS on Fibromyalgia Pain

Starting soon · Not applicable · Has a placebo group

Conditions studied: Fibromyalgia, Pain

In brief

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.

Key facts

Study ID

NCT06193317

Run by

Spaulding Rehabilitation Hospital

People needed

152

Starts

2026-06-01

Expected to finish

2029-05-01

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

• Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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