Auricular (ear) vagus nerve stimulation for rheumatoid arthritis
Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | taVNS AB Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 6 sites (Lund, Skåne County and 5 other locations) |
| Trial ID | NCT06779123 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lund, Skåne County and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.