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RECRUITING
NCT07017686
NA

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

View on ClinicalTrials.gov

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.

Official title: The Reboot Study: A Single Group, Open Label Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2025-09

Completion Date

2031-12

Last Updated

2025-09-22

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (3)

Bionics Institute

Fitzroy, Victoria, Australia

St Vincent's Hospital, Department of Rheumatology

Fitzroy, Victoria, Australia

Austin Health, Heidelberg Repatriation Hospital

Ivanhoe, Victoria, Australia