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

NCT07543302 | Enrolling By Invitation DMC

• 2 other identifiers: CIV-SE-25-06-053095Dnr: 5.1.1-2025-067582
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Duchenne Muscular Dystrophy (DMD)

Keywords

vagus nerve stimulation,; taVNS; inflammatory reflex; cholinergic antiinflammatory mechanism; immunomodulation; antiinflammatory therapy; Duchenne muscular dystrophy

Outcome Measures

Primary Outcomes (1)

• The dynamic changes in plasma levels of multiple inflammatory molecules in response to taVNS therapy will be studied

  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

Study Arms (1)

Transcutaneous auricular vagus nerve stimulation in DMD patients

EXPERIMENTAL

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

Interventions

Transcutaneous auricular vagus nerve stimulation DEVICE

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.

Transcutaneous auricular vagus nerve stimulation in DMD patients

Eligibility Criteria

• Age: 5 Years - 17 Years
• Gender Eligibility Details: Duchenne Muscular Dystrophy is a genetic disease that affects males
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• taVNS AB: lead
• Region Stockholm: collaborator

Study Sites (1)

Astrid Lindgren Children´s Hospital

Stockholm, 17176, Sweden

Location

Related Publications (8)

• Andersson U, Tracey KJ. Neural reflexes in inflammation and immunity. J Exp Med. 2012 Jun 4;209(6):1057-68. doi: 10.1084/jem.20120571.

  PMID: 22665702 RESULT

• Gaylis NB, Sikes D, Kivitz A, Horowitz DL, Evangelista M, Levine YA, Chernoff D. Neuroimmune Modulation for Drug-Refractory Rheumatoid Arthritis: Long-Term Safety and Efficacy in Patients Enrolled in a Pilot Vagus Nerve Stimulation Study. Rheumatol Ther. 2025 Dec;12(6):1125-1136. doi: 10.1007/s40744-025-00798-y. Epub 2025 Oct 10.

  PMID: 41071520 RESULT

• De Pasquale L, D'Amico A, Verardo M, Petrini S, Bertini E, De Benedetti F. Increased muscle expression of interleukin-17 in Duchenne muscular dystrophy. Neurology. 2012 Apr 24;78(17):1309-14. doi: 10.1212/WNL.0b013e3182518302. Epub 2012 Apr 11.

  PMID: 22496194 RESULT

• Andersson U, Tracey KJ. Vagus nerve SARS-CoV-2 infection and inflammatory reflex dysfunction: Is there a causal relationship? J Intern Med. 2024 Jan;295(1):91-102. doi: 10.1111/joim.13746. Epub 2023 Nov 29.

  PMID: 38018736 RESULT

• Villaldama-Soriano MA, Rodriguez-Cruz M, Hernandez-De la Cruz SY, Almeida-Becerril T, Cardenas-Conejo A, Wong-Baeza C. Pro-inflammatory monocytes are increased in Duchenne muscular dystrophy and suppressed with omega-3 fatty acids: A double-blind, randomized, placebo-controlled pilot study. Eur J Neurol. 2022 Mar;29(3):855-864. doi: 10.1111/ene.15184. Epub 2021 Nov 26.

  PMID: 34779542 RESULT

• Rosas-Ballina M, Olofsson PS, Ochani M, Valdes-Ferrer SI, Levine YA, Reardon C, Tusche MW, Pavlov VA, Andersson U, Chavan S, Mak TW, Tracey KJ. Acetylcholine-synthesizing T cells relay neural signals in a vagus nerve circuit. Science. 2011 Oct 7;334(6052):98-101. doi: 10.1126/science.1209985. Epub 2011 Sep 15.

  PMID: 21921156 RESULT

• Andersson U, Tracey KJ. A new approach to rheumatoid arthritis: treating inflammation with computerized nerve stimulation. Cerebrum. 2012 Mar;2012:3. Epub 2012 Mar 21.

  PMID: 23447789 RESULT

• Andersson U, Tracey KJ. Reflex principles of immunological homeostasis. Annu Rev Immunol. 2012;30:313-35. doi: 10.1146/annurev-immunol-020711-075015. Epub 2012 Jan 6.

  PMID: 22224768 RESULT

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)