The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis

This safety study is testing a device that delivers gentle electrical stimulation to the vagus nerve in the abdomen (abdominal vagus nerve stimulation) to treat rheumatoid arthritis (RA) — a chronic autoimmune disease causing joint pain and swelling — in patients whose disease has not responded to multiple biologic or targeted medications. **You may be eligible if...** - You are between 18 and 75 years old with adult-onset rheumatoid arthritis - You test positive for rheumatoid factor (RF) or anti-CCP antibodies - You have moderate-to-severe active disease (at least 4 tender and 4 swollen joints) - You have tried and failed at least 2 biologic or targeted synthetic disease-modifying drugs (DMARDs) over at least 3 months - You are currently on at least one stable biologic or targeted DMARD - You are eligible for Medicare **You may NOT be eligible if...** - You have had a prior vagotomy, splenectomy, or bariatric surgery - You have a stomach hernia (hiatus hernia) - You have an implanted cardiac device (e.g., pacemaker) - You have a major uncontrolled psychiatric disorder - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.