The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
Sponsor: The Bionics Institute of Australia • ClinicalTrials.gov ID: NCT07017686
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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.
Interventions
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abdominal vagus nerve stimulation (aVNS)
(Device)
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.
Eligibility criteria
Conditions
Locations
- Bionics Institute — Fitzroy, Victoria, Australia
- St Vincent's Hospital, Department of Rheumatology — Fitzroy, Victoria, Australia
- Austin Health, Heidelberg Repatriation Hospital — Ivanhoe, Victoria, Australia
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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