Safety Evaluation of Abdominal Vagus Nerve Stimulation Device for Adults Aged 18 to 75 with Moderate to Severe Rheumatoid Arthritis Not Responding to Medication

What this Trial Is About

This research aims to evaluate the safety of abdominal vagus nerve stimulation aVNS in adults with moderate to severe rheumatoid arthritis RA that has not responded to medication. This open-label study involves participants with drug-refractory RA, assessing how the implanted aVNS device performs and its safety over time. The trial is conducted by The Bionics Institute of Australia and focuses on adult-onset RA patients aged 18 to 75 years. Participants will receive the aVNS device implanted via keyhole laparoscopic surgery. Starting two weeks after implantation, stimulation will be delivered daily for three hours each day during the initial 22-week treatment phase. After this initial phase, participants may choose to continue using the device or have it deactivated, though the device remains implanted unless removal is clinically necessary or requested. The follow-up phase includes monitoring participants twice a year for up to five years. Throughout the study, participants will undergo clinical assessments of RA symptoms and device performance at 2, 6, 12, and 24 weeks after surgery. Safety reports and device checks will be conducted during these visits. After the initial treatment phase, ongoing monitoring for safety and device function will continue biannually for up to five years. Overall, participants are involved in the trial for approximately five years, during which their health and device outcomes are closely observed.

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