Duchenne Muscular Dystrophy (DMD)Travagus OneNCT07543302
Can External Vagus Nerve Stimulation Reduce Systemic Levels of Inflammatory Mediators in Duchenne Muscular Dystrophy Patients?
A study testing Transcutaneous auricular vagus nerve stimulation in people with Duchenne Muscular Dystrophy (DMD), run by taVNS AB at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 17 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 13 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Confirmed DMD diagnosis
- Informed consent signed by the legal guardian and the patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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:
- Can taVNS treatment for a week reduce systemic levels of inflammatory molecules?
- 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.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- Transcutaneous auricular vagus nerve stimulation
- Keywords
- vagus nerve stimulation,, taVNS, inflammatory reflex, cholinergic antiinflammatory mechanism, immunomodulation, antiinflammatory therapy, Duchenne muscular dystrophy
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagus nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to end of treatment at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start13 Apr 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- taVNS AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Region Stockholm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543302
- Sponsor's protocol ID
- CIV-SE-25-06-053095
- Other IDs
- Dnr: 5.1.1-2025-067582
- Acronym
- Travagus One
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22665702Gaylis 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.
PubMed 41071520De 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.
PubMed 22496194Andersson 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.
PubMed 38018736Villaldama-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.
PubMed 34779542Rosas-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.
PubMed 21921156Andersson U, Tracey KJ. A new approach to rheumatoid arthritis: treating inflammation with computerized nerve stimulation. Cerebrum. 2012 Mar;2012:3. Epub 2012 Mar 21.
PubMed 23447789Andersson 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.
PubMed 22224768
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07543302
- Acronym / sponsor ID
- Travagus One / CIV-SE-25-06-053095
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- vagus nerve stimulation,, taVNS, inflammatory reflex, cholinergic antiinflammatory mechanism, immunomodulation, antiinflammatory therapy, Duchenne muscular dystrophy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- taVNS ABIndustry (pharma, biotech, devices)
- Collaborators
- Region Stockholm
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Can taVNS treatment for a week reduce systemic levels of inflammatory molecules?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation in DMD patients | Experimental | Device: Transcutaneous auricular vagus nerve stimulationThe 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Confirmed DMD diagnosis
- Informed consent signed by the legal guardian and the patient
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulationThe 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. | Device | Transcutaneous auricular vagus nerve stimulation in DMD patients |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Results publication: PubMed 22665702Andersson U, Tracey KJ. Neural reflexes in inflammation and immunity. J Exp Med. 2012 Jun 4;209(6):1057-68. doi: 10.1084/jem.20120571.
- Results publication: PubMed 41071520Gaylis 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.
- Results publication: PubMed 22496194De 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.
- Results publication: PubMed 38018736Andersson 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.
- Results publication: PubMed 34779542Villaldama-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.
- Results publication: PubMed 21921156Rosas-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.
- Results publication: PubMed 23447789Andersson U, Tracey KJ. A new approach to rheumatoid arthritis: treating inflammation with computerized nerve stimulation. Cerebrum. 2012 Mar;2012:3. Epub 2012 Mar 21.
- Results publication: PubMed 22224768Andersson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular vagus nerve stimulation in people with Duchenne Muscular Dystrophy (DMD), run by taVNS AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07543302, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.