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Study identifier: NCT07017686 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Arthritis, Rheumatoid  ·  Sponsor: The Bionics Institute of Australia

PhaseNA
Planned participants5
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

A/Prof Shereen Oon, MBBS, PhD  ·  +61392311203  ·  rheumclintrials@svha.org.au

Angela Chia, RN  ·  +61392311203  ·  rheumclintrials@svha.org.au

Always discuss trial participation with your own doctor first.

Locations (3)

Bionics InstituteFitzroy, Victoria, AustraliaRecruiting
St Vincent's Hospital, Department of RheumatologyFitzroy, Victoria, AustraliaRecruiting
Austin Health, Heidelberg Repatriation HospitalIvanhoe, Victoria, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT07017686