Auricular (ear) vagus nerve stimulation for rheumatoid arthritis
Official title: Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis
Run by taVNS AB · NCT06779123 · Data updated 2026-11-12
This trial will test a non-invasive ear-based electrical stimulator (taVNS) to see if it lowers inflammation and improves symptoms in adults with moderate-to-severe rheumatoid arthritis who haven't responded to biologic or targeted DMARDs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | taVNS AB Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 6 sites (Lund, Skåne County and 5 other locations) |
| Status | Recruiting |
| Started | March 21, 2025 |
| Main results expected | October 15, 2026 |
| Study ends | June 15, 2027 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT06779123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with active moderate-to-severe RA (DAS28 > 3.2 with ≥4 tender and ≥4 swollen joints) who have had inadequate response, loss of response, or intolerance to one or more approved biologic or targeted synthetic DMARDs and are on stable background therapy are ideal candidates.
✕Probably not a fit
Patients with prior vagotomy or splenectomy, recurrent vasovagal syncope, uncontrolled psychiatric illness or fibromyalgia, significant cardiovascular disease, certain immunodeficiencies, pregnancy, or those who are stable and well controlled on current therapies are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, double-blind, placebo-controlled superiority trial testing a novel transcutaneous auricular vagus nerve stimulator (TRAVAGUS) versus a sham device in patients with moderate-to-severe rheumatoid arthritis who are incomplete responders or intolerant to biologic or targeted synthetic DMARDs. Participants receive regular taVNS or non-stimulation sessions while continuing stable background csDMARDs or glucocorticoids, with safety monitoring throughout. The primary efficacy endpoint is the proportion achieving ACR20, with secondary outcomes including pain, fatigue, functional status, and adverse events. The study is conducted at multiple Swedish rheumatology centers with blinded outcome assessment.
Why it matters
Potential benefit: If successful, taVNS could offer a non-drug, lower-risk treatment option to reduce inflammation and symptoms for RA patients who do not respond to or cannot tolerate current biologic or targeted therapies.
How similar studies have gone: Preclinical studies and small clinical trials of vagus nerve stimulation have shown promising anti-inflammatory effects, but large randomized trials specifically in RA are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> 18 years of age on day of signing informed consent * Active RA, DAS28\>3.2, at least 4/28 tender and 4/28 swollen joints * Demonstrated an inadequate response, loss of response, or intolerance to one or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors. * Stable dose of glucocorticoids or conventional disease-modifying agents in RA (csDMARDs) at least 2 and 4 weeks, respectively, before screening Exclusion Criteria: * History of vagotomy * Partial or complete splenectomy * Recurrent vasovagal syncope episodes * Untreated or poorly controlled psychiatric illness * Significant immunodeficiency due to underlying illness * History of cerebrovascular insult * Clinically significant cardiovascular disease * Uncontrolled fibromyalgia * Pregnancy (if sexually active, using reliable form of birth control or being at least 2 yrs post-menopausal)
Where it's running
-
Section for Rheumatology, Skåne University Hospital, Lund
Lund, Skåne County, Sweden Recruiting -
Section for Rheumatology, Skåne University Hospital, Malmö
Malmö, Sweden Recruiting -
Dept of Rheumatology, Örebro University Hospital
Örebro, Sweden Recruiting -
Center for Rheumatology, Academic Specialist Centre
Stockholm, Sweden Recruiting -
Karolinska University Hospital
Stockholm, Sweden Recruiting -
Dept of Rheumatology, Umeå University Hospital
Umeå, Sweden Recruiting
Study contacts
- Study coordinator: Jon Lampa, Professor
- Email: jon.lampa@ki.se
- Phone: +46 12370000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.