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NCT Number: NCT06193317

Effects of taVNS on Fibromyalgia Pain

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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).

Treatment and study plan

Transauricular vagus nerve stimulation (taVNS)

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).

Primary outcomes

  1. pain severity using the Brief Pain Inventory (BPI pain)

    Time frame: From Baseline to Visit 19 (at 4 weeks)

    Brief Pain Inventory (BPI) is a short self-assessment questionnaire that provides information on various dimensions of pain including how pain developed, the types of pain a patient experiences, time of day pain is experienced, as well as current ways of alleviating pain. The BPI also includes the Visual Analog Scale (VAS) Pain scale, a simple 10-point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring patients' pain, on average and at the present time. The BPI provides information on pain intensity (the sensory dimension) and the degree to which pain interferes with function (the reactive dimension).

Study contacts

Contact information is provided by the study sponsor or research team.

Elly Pichardo, MD

CONTACT

617 952 6154

Felipe Fregni, MD, PhD, MPH

CONTACT

[email protected]

617 952 6158

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 5, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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