Status:
NOT_YET_RECRUITING
Effects of taVNS on Fibromyalgia Pain
Lead Sponsor:
Spaulding Rehabilitation Hospital
Conditions:
Fibromyalgia, Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06193317
Start Date
June 1 2026
End Date
May 1 2029
Last Update
September 19 2025
Active Locations (1)
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1
Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States, 02138