NCT07017686 The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
| NCT ID | NCT07017686 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Bionics Institute of Australia |
| Condition | Arthritis, Rheumatoid |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-09 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2025-09 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Contact & Investigator
A/Prof Shereen Oon
PRINCIPAL INVESTIGATOR
St Vincent's Hospital Melbourne
Frequently Asked Questions
Who can join the NCT07017686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Arthritis, Rheumatoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07017686 currently recruiting?
Yes, NCT07017686 is actively recruiting participants. Contact the research team at rheumclintrials@svha.org.au for enrollment information.
Where is the NCT07017686 trial being conducted?
This trial is being conducted at Fitzroy, Australia, Fitzroy, Australia, Ivanhoe, Australia.
Who is sponsoring the NCT07017686 clinical trial?
NCT07017686 is sponsored by The Bionics Institute of Australia. The principal investigator is A/Prof Shereen Oon at St Vincent's Hospital Melbourne. The trial plans to enroll 5 participants.