No phaseRecruiting
The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
The Reboot Study: A Single Group, Open Label Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
- Sponsor
- The Bionics Institute of Australia (Academic or other)
- Enrolment
- 5 planned
- Conditions
- Arthritis, Rheumatoid
- Interventions
- abdominal vagus nerve stimulation (aVNS)
- Ages
- adults, older adults
- Registry
- NCT07017686
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered