The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
Condition(s) studied
Investigational drug(s) / intervention(s)
abdominal vagus nerve stimulation (aVNS): Participants will receive aVNS, delivered by a commercially available stimulator placed under the skin, and a custom-designed electrode array attached to the abdominal vagus nerve. Stimulation will commence 2 weeks after laparoscopic surgical implantation of the device, and occur daily for 22-weeks stimulation in the initial phase of the study.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA. — 24 weeks
Rate of recorded Serious Adverse Device Effects (SADEs) less than that for the Evoke® device (2%), a commercially available, FDA approved, CE marked implantable spinal cord stimulator. - Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA. — 24 weeks
No significant increase in electrically Evoked Compound Action Potentials (ECAPs) threshold - Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA. — 24 weeks
No significant decrease in amplitude of electrically Evoked Compound Action Potentials (ECAPs)
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Bionics Institute | Fitzroy | Victoria | Recruiting |
| St Vincent's Hospital, Department of Rheumatology | Fitzroy | Victoria | Recruiting |
| Austin Health, Heidelberg Repatriation Hospital | Ivanhoe | Victoria | Recruiting |
More The Bionics Institute of Australia trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07017686 on ClinicalTrials.gov ↗ ← All trials in Australia