Vagus Nerve Stimulation for Fibromyalgia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Spaulding Rehabilitation Hospital

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with fibromyalgia, a condition characterized by widespread musculoskeletal pain. Participants should be diagnosed with fibromyalgia or myofascial pain syndrome to qualify.

Inclusion Criteria

Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 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

+1 more

Exclusion Criteria

I am not pregnant and agree to regular pregnancy tests if of child-bearing age.

History of substance abuse within the past 6 months as self-reported (if subject reports a history of substance abuse, we will confirm using DSM V criteria)

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

+1 more

Participant Groups

The study is testing the effects of transauricular vagus nerve stimulation (taVNS), which involves a non-invasive device placed on the ear to potentially alleviate pain in fibromyalgia patients.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active taVNSExperimental Treatment1 Intervention

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.

Group II: Sham taVNSPlacebo Group1 Intervention

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.

Transauricular vagus nerve stimulation (taVNS) is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Transcutaneous Auricular Vagus Nerve Stimulation for: