Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
The overall goal of this clinical trial is to evaluate the causality relationship between the non vagus nerve stimulation waveform parameters and the therapeutic effect. Thus, unlocking a pathway to optimize parameters that maximize the benefits of therapy and minimize unwanted side effects. The experimental design includes the analysis of physiological signals, clinical biomarkers of disease, and clinical outcomes to determine the most effective measures for the monitoring, optimization, and personalization of non vagus nerve stimulation in systemic lupus erythematosus disease.
• Systemic lupus erythematosus (SLE) (defined by the American College of Rheumatology- or SLICC criteria)
• Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale
• BILAG C on Musculoskeletal Domain of the BILAG 2004
• If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline,
• If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline
• Able and willing to give written informed consent and comply with the requirements of the study protocol.