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

Recruiting N/A Interventional Study
Arthritis, Rheumatoid
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
5 (estimated)
Sponsor
The Bionics Institute of Australia · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female (18 - 75 years of age). 2. Adult-onset rheumatoid arthritis (RA) (onset age 18 years or above) as defined by the 2010 ACR/EULAR classification criteria, and Rheumatoid Factor (RF) or Cyclic Citrullinated Peptide (CCP) Antibody/Anti-Citrullinated Peptide Antibod…
Contacts

A/Prof Shereen Oon, MBBS, PhD

+61392311203

rheumclintrials@svha.org.au

CONTACT

Angela Chia, RN

+61392311203

rheumclintrials@svha.org.au

CONTACT