Can External Vagus Nerve Stimulation Reduce Systemic Levels of Inflammatory Mediators in Duchenne Muscular Dystrophy Patients? (Travagus One)

April 21, 2026 updated by: taVNS AB

A Pilot Study to Evaluate Safety and Ability of the Transcutaneous Auricular Vagus Nerve Stimulator the Travagus One System to Decrease Inflammatory Mediators in Patients With Duchenne Muscular Dystrophy.

The intended investigation is a pilot study to evaluate the safety and efficacy of a novel transcutaneous auricular vagus nerve stimulator system, termed TRAVAGUS ONE, to reduce systemic levels of inflammatory mediators in patients with Duchenne muscular dystrophy (DMD). Electrical vagus nerve stimulation is an investigational anti-inflammatory therapy targeting the nervous system to modulate dysregulated inflammation. DMD is a severe genetic disorder characterized by progressive muscle degeneration and weakness due to the alterations of a protein named dystrophin that helps keep muscle cells intact. The disease affects male children, and the symptom onset is in early childhood. In addition to the muscle degeneration all patients suffer from severe systemic inflammation and express increased systemic levels of proinflammatory molecules, which can be quantified in peripheral blood samples. Daily, systemic corticosteroid therapy with high doses is the standard of care in DMD to control symptoms and to slow disease progression through potent anti-inflammatory activity. Unfortunately, high dosage and long-term use of corticosteroids are typically also accompanied by severe adverse effects that reduce the quality of life in DMD patients. There is thus a great need for improved anti-inflammatory treatment with less severe adverse effects.

In the planned pilot study involving 20 DMD patients aged 5-17 years, the investigators intend to treat each patient for one week in their home environment using transcutaneous auricular vagus nerve stimulation (taVNS) with a novel device named Travagus One to find out whether this intervention is safe and may reduce systemic levels of proinflammatory molecules. Venous blood samples will be collected at three different time points before and after the taVNS treatment period.

Note: This study relates to an FDA-nonregulated Device. There are no U.S. Locations for the study. The study was approved by the Swedish Medical Products Agency.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Purpose and aim:

The overall aim is to investigate efficacy and safety of a newly developed non-invasive, auricular, investigational equipment named the TRAVAGUS ONE System that electrically stimulates the auricular branch of the vagus nerve to activate the cholinergic anti-inflammatory mechanism to study possible inhibiting effects on increased levels of systemic inflammatory mediators in DMD patients. The mode of treatment is termed transcutaneous auricular vagus nerve stimulation (taVNS). Specifically, we will address the following research questions:

  1. Can taVNS treatment for a week reduce systemic levels of inflammatory molecules?
  2. What is the safety profile of taVNS? Survey of the field Several thousand children with epilepsy have over the past 10 years been treated with invasive or external taVNS therapy with no or mild adverse effects. There is a clinical need for improved anti-inflammatory therapy with less serious adverse effects in DMD. The aim of our planned study is to investigate whether taVNS treatment via the cholinergic anti-inflammatory mechanism may reduce systemic levels of inflammatory molecules involved in the pathogenesis of DMD. If so, that would motivate future extended therapeutic taVNS studies in DMD patients. Therapy using taVNS is based on non-invasive activation of the endogenous cholinergic anti-inflammatory pathway, a mechanism discovered by Kevin Tracey, one of the founders of taVNS AB, which is the sponsoring company of the present clinical investigation. The cholinergic anti-inflammatory pathway is the efferent part of the inflammatory reflex, a neural circuit that counteracts exaggerated dysfunctional inflammatory responses. The anti-inflammatory effects are mediated via acetylcholine released via the vagus system and a subset of mobile T lymphocytes (T ChAT-cells) capable of acetylcholine synthesis. These anti-inflammatory T cells operate both within and outside compartments innervated by the vagus system. Alpha-7 nicotinic acetylcholine receptors (alpha-7nAChR) respond to acetylcholine by guiding activities downregulating proinflammatory cytokine synthesis, redirecting the traffic of mobile inflammatory cells, and converting pro-inflammatory macrophages to healing macrophages. Using a surgically implanted vagus nerve stimulator Kevin Tracey and Ulf Andersson (the author of this document) provided the original clinical report in 2012 of successful VNS treatment in a chronic inflammatory disease. Multiple pilot studies using either invasive or external VNS in various inflammatory diseases have supported the validity of the original discovery. FDA approved an implantable vagus nerve stimulating device for treatment of rheumatoid arthritis in July 2025 as a result of a successful randomized, placebo-controlled multicenter study with rheumatoid arthritis patients refractory to conventional therapy.

The auricular branch of the vagus nerve is a sensory nerve to the external ear including the cymba conchae region. Stimulation of this auricular nerve branch delivers afferent neuronal impulses, whereas cervically implanted devices deliver both efferent and afferent vagus nerve stimulation. Extended experience from therapeutic epilepsy studies has provided reassuring safety results regarding taVNS therapy. Functional magnetic resonance imaging demonstrates that taVNS activates the main vagal afferent pathway through the brainstem to upstream cortical projections in a similar way to implanted cervical VNS electrodes, confirming this nerve as a suitable non-invasive target to administer vagus nerve stimulation.

Study design:

The study plan is to include 20 boys with DMD treated at Astrid Lindgren Children´s Hospital (ALB), which is the pediatric unit of the Karolinska University Hospital in Stockholm, Sweden. The study will comprise a pilot investigation performed for one week in each DMD patient aged 5-17 years. The therapeutic intervention is electrical taVNS with the TRAVAGUS ONE device in the auricular cymba conchae/cavum conchae regions of the left ear for 5 minutes/twice daily for one week. Venous blood samples will be collected in EDTA-tubes at the first visit before taVNS, and after 24 and 168 hours, respectively. Plasma samples will be frozen for later quantitative analysis of inflammatory mediators.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Astrid Lindgren Children´s Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed DMD diagnosis
  • Informed consent signed by the legal guardian and the patient

Exclusion Criteria:

  • Age <5 years
  • Wounds, skin irritation, or infection in the left auricle
  • Previous vagotomy or other interventions that may have hampered vagus nerve functions
  • Inability, even with the assistance of a guardian, to acquire adequate technique for ear stimulation
  • Previous partial or complete splenectomy
  • Severe cardiac disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous auricular vagus nerve stimulation in DMD patients
The transcutaneous auricular vagus nerve stimulation will be performed for 5 minutes twice daily for one week in a home environment using the TRAVAGUS ONE system.
Device: Transcutaneous auricular vagus nerve stimulation
The transcutaneous auricular vagus nerve stimulation will be performed for 5 minutes twice daily for one week in a home environment using the TRAVAGUS ONE system, which encompasses two investigational device components connected via an electrical cable. The components include a headset (class I medical device) with auricular electrodes connected to a pulse generator (class II a medical device), both manufactured by the sponsoring company taVNS AB. The system delivers safe, charge-balanced, current-controlled, asymmetrical, bi-phasic, square waves via two aluminium electrodes with adequate electrical conductivity without a need for electrode gel application to cutaneous areas in the cymba and cavum conchae region of the left ear. A second advantage with the design of the TRAVAGUS ONE electrode headset is that the headband provides a pushing force on the electrodes to optimize conductivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The dynamic changes in plasma levels of multiple inflammatory molecules in response to taVNS therapy will be studied
Time Frame: From enrollment to end of treatment at 1 week
The following molecules will be analyzed: IFN-gamma, IL-1 alpha, IL-1 beta, IL-1 RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, TNF, IP-10, MCP-1, MIP-1, MIP-1, RANTES, PDGFBB, bFGF, G-CSF, GM-CSF, VEGF
From enrollment to end of treatment at 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

taVNS AB

Collaborators

Region Stockholm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 13, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIV-SE-25-06-053095
  • Dnr: 5.1.1-2025-067582 (Other Identifier: Swedish Medical Products Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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