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Recruiting Not applicable

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

NCT07017686 · tracked via the Priya Life Science Australia tracker
Sponsor
The Bionics Institute of Australia
Phase
Not applicable
Started
2026-08-11
Last updated
2026-10-02

Condition(s) studied

Arthritis, Rheumatoid

Investigational drug(s) / intervention(s)

abdominal vagus nerve stimulation (aVNS)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 Antibody (ACPA) must be positive (above lab ranges). 3. Moderate-severe active RA defined by at least 4/28 tender and 4/28 swollen joints. 4. Have active disease that has not responded to a 3-month trial of, or has intolerance limiting a full 3 month trial of, at least 2 biologic and/or new targeted synthetic DMARDs (e.g. JAK inhibitors). 5. Using a stable, continuous dose of at least 1 biological and/or synthetic DMARD for \>8 weeks prior to study screening and for the duration of the trial. 6. Women of childbearing age must not be pregnant or trying to become pregnant and must agree to use an effective method of contraception for the duration of their participation in the trial. 7. Medicare eligibility. 8. Provision of informed consent, in the form of a signed and dated informed consent form. Exclusion Criteria: 1. Unable or unwilling to provide written informed consent. 2. Current diagnosis of major psychiatric disorder/s, or meets criteria as such on the Mini International Neuropsychiatric Interview (MINI), with the exception of stable, well controlled Major Depression or Anxiety Disorder. 3. A medical condition that could interfere with study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator. 4. Medical conditions that have resulted in severe autonomic neuropathy e.g. poorly controlled type 2 diabetes or metabolic disease. 5. History of previous surgical interventions including vagotomy, splenectomy, bariatric surgery. 6. History of gastric hiatus hernia. 7. Previously implanted active medical devices (e.g., dorsal root ganglion or spinal cord stimulators, cardiac pacemakers, automatic implantable cardioverter-defibrillators, drug pumps), or likely need for implantation of such devices within 6 months after start of this study. 8. A condition that requires routine Magnetic Resonance Imaging (MRI) scans 9. Is, in the opinion of the Principal Investigator/s not a suitable candidate for the trial.

Primary outcome measure(s)

  • Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA. — 24 weeks
    Rate of recorded Serious Adverse Device Effects (SADEs) less than that for the Evoke® device (2%), a commercially available, FDA approved, CE marked implantable spinal cord stimulator.
  • Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA. — 24 weeks
    No significant increase in electrically Evoked Compound Action Potentials (ECAPs) threshold
  • Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA. — 24 weeks
    No significant decrease in amplitude of electrically Evoked Compound Action Potentials (ECAPs)

Trial sites (3)

FacilityCityRegionStatus
Bionics Institute Fitzroy Victoria Recruiting
St Vincent's Hospital, Department of Rheumatology Fitzroy Victoria Recruiting
Austin Health, Heidelberg Repatriation Hospital Ivanhoe Victoria Recruiting

More The Bionics Institute of Australia trials in Australia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07017686 on ClinicalTrials.gov ↗ ← All trials in Australia