Transcutaneous Vagus Nerve Stimulation in SLE

Launched by NORTHWELL HEALTH · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with systemic lupus erythematosus (SLE), a chronic disease that often causes joint and muscle pain as well as fatigue. Researchers are exploring a method called transcutaneous vagus nerve stimulation (tcVNS), which involves gently stimulating the vagus nerve through the skin at the neck or ear. This approach aims to reduce pain and fatigue in SLE patients without the side effects associated with many current treatments. The trial will involve 18 participants who will receive either the real stimulation or a sham (placebo) treatment for 28 days, followed by monitoring for another 28 days to see how long any benefits last.

To be eligible for this trial, participants must have SLE and experience a certain level of pain. They should not have started or changed certain medications recently and must be willing to follow the study's guidelines. Throughout the trial, participants will self-administer the stimulation for just 5 minutes a day, and neither they nor the researchers will know who is receiving the real treatment or the placebo. The researchers will closely monitor any changes in pain, fatigue, and overall disease activity, as well as any potential side effects. This study could lead to a valuable new treatment option that is safe and effective for managing some of the most challenging symptoms of SLE.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • SLE (defined by the ACR or SLICC criteria),
• • Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale,
• • BILAG C or greater on the Musculoskeletal Domain of the BILAG 2004,
• • If on corticosteroids, the dose must be stable and ≤ 10 mg/day (prednisone or equivalent) for at least 14 days before baseline,
• • If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline,
• • If on NSAIDS, the dose must be stable for at least 7 days before baseline and the subject must be willing not to change the dose during the trial (except for toxicity),
• • Able and willing to give written informed consent and comply with the requirements of the study protocol.
• Exclusion Criteria:
• • Initiation of immunosuppressive or antimalarial treatment within 3 months of baseline,
• • Treatment with cyclophosphamide within 2 months of baseline,
• • Initiation of anifrolumab within 3 months of baseline
• • Initiation of belimumab within 6 months of baseline,
• • Expectation to increase steroids and/or immunosuppressive treatment,
• • Anti-phospholipid syndrome,
• • Fibromyalgia,
• • Treatment with an anti-cholinergic medication, including over the counter medications,
• • Any implantable electronic devices including pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators,
• • Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine),
• • Joint replacement within 60 days prior to study enrollment or planned within the course of the study,
• • Any planned surgical procedure requiring general anesthesia within the course of the study,
• • Intra-articular cortisone injections within 28 days of the start of study,
• • Chronic inflammatory disorders apart from SLE affecting the joints,
• • Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
• • Active infection including hepatitis B or hepatitis C at baseline,
• • Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
• • Pregnancy or lactation (Pregnancy status will be determined via serum blood test \& lactation will be determined via self-report),
• • Comorbid disease that has previously required administration of corticosteroid use,
• • Known allergy to mannitol or lactulose,
• • Chronic treatment with narcotic medication,
• • Prior receipt of transauricular vagus nerve stimulation in a clinical trial,
• • Inability to comply with study and follow-up procedures.