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

This open label clinical trial aims to assess the safety of abdominal vagus nerve stimulation (aVNS) for moderate to severe, adult-onset rheumatoid arthritis (RA) that has not responded to medication. The aVNS is an active medical device placed into the body to allow electrical stimulation of the abdominal vagus nerve. Participants will undergo stimulation treatment with the aVNS device from two to 24 weeks after the device is implanted by keyhole surgery. Safety, device performance and potential benefits will be assessed. Participants will be monitored for specific events for 5 years post surgery.

NCT Number	NCT07017686
Lead Sponsor	The Bionics Institute of Australia Collaborators: St Vincent's Hospital Melbourne, Austin Health
Conditions	Arthritis, Rheumatoid
Enrollment	5 participants
Start Date	2025-09
Primary Completion	2027-09 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2025-09-22