Tests a nerve stimulation device in adults with rheumatoid arthritis
Tests safety of an implanted device stimulating the vagus nerve in rheumatoid arthritis patients.
Plain-language title generated from the registry record
Registry title: The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
Key facts
- Where
- Fitzroy and Ivanhoe, AustraliaSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07017686, who can take part
Where in Australia
- Bionics InstituteFitzroy, AustraliaTaking people
- St Vincent's Hospital, Department of RheumatologyFitzroy, AustraliaTaking people
- Austin Health - Heidelberg Repatriation HospitalIvanhoe, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Bionics Institute of Australia
- Trial code
- NCT07017686
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
The Reboot Study: A Single Group, Open Label Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
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.
Inclusion: Male or female (18 - 75 years of age); 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); Moderate-severe active RA defined by at least 4/28 tender and 4/28 swollen joints; 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); 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; 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; Medicare eligibility; Provision of informed consent, in the form of a signed and dated informed consent form.
Exclusion: History of previous surgical interventions including vagotomy, splenectomy, bariatric surgery; 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; 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; A medical condition that could interfere with study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator; Medical conditions that have resulted in severe autonomic neuropathy e.g. poorly controlled type 2 diabetes or metabolic disease; History of gastric hiatus hernia; A condition that requires routine Magnetic Resonance Imaging (MRI) scans; Unable or unwilling to provide written informed consent; Is, in the opinion of the Principal Investigator/s not a suitable candidate for the trial.