NCT06193317

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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
2.4 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

December 21, 2023

Last Update Submit

September 15, 2025

Conditions

Fibromyalgia, Pain

Outcome Measures

Primary Outcomes (1)

  • pain severity using the Brief Pain Inventory (BPI pain)

    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).

    From Baseline to Visit 19 (at 4 weeks)

Study Arms (2)

Active taVNS

EXPERIMENTAL

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.

Device: Transauricular vagus nerve stimulation (taVNS)

Sham taVNS

SHAM COMPARATOR

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.

Device: Transauricular vagus nerve stimulation (taVNS)

Interventions

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).

Active taVNSSham taVNS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (4)

  • Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.

    PMID: 36543841RESULT

  • Parente J, Carolyna Gianlorenco A, Rebello-Sanchez I, Kim M, Mario Prati J, Kyung Kim C, Choi H, Song JJ, Fregni F. Neural, Anti-Inflammatory, and Clinical Effects of Transauricular Vagus Nerve Stimulation in Major Depressive Disorder: A Systematic Review. Int J Neuropsychopharmacol. 2024 Mar 1;27(3):pyad058. doi: 10.1093/ijnp/pyad058.

    PMID: 37870480RESULT

  • Gianlorenco ACL, de Melo PS, Marduy A, Kim AY, Kim CK, Choi H, Song JJ, Fregni F. Electroencephalographic Patterns in taVNS: A Systematic Review. Biomedicines. 2022 Sep 6;10(9):2208. doi: 10.3390/biomedicines10092208.

    PMID: 36140309RESULT

  • Molero-Chamizo A, Nitsche MA, Bolz A, Andujar Barroso RT, Alameda Bailen JR, Garcia Palomeque JC, Rivera-Urbina GN. Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol. Brain Sci. 2022 Jan 12;12(1):95. doi: 10.3390/brainsci12010095.

    PMID: 35053839RESULT

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Felipe Fregni, MD, PhD, MPH

CONTACT

617 952 6158fregni.felipe@mgh.harvard.edu

Elly Pichardo, MD

CONTACT

617 952 6154

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Spaulding Neuromodulation Center

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 5, 2024

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

US(1)