Effects of taVNS on Fibromyalgia Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2029-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia, Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active taVNS

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 Type EXPERIMENTAL

Transauricular vagus nerve stimulation (taVNS)

Intervention Type DEVICE

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).

Sham taVNS

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.

Group Type SHAM_COMPARATOR

Transauricular vagus nerve stimulation (taVNS)

Intervention Type DEVICE

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).

Interventions

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Transauricular vagus nerve stimulation (taVNS)

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No