NCT07017686Recruiting
The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
The Reboot Study: A Single Group, Open Label Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 4 Jun 2025
- Start date
- 11 Aug 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- The Bionics Institute of Australia
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07017686
What you commit to
- Study type: Interventional
- Planned participants: 5
- From 11 Aug 2026 to the primary completion date, 30 Sept 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Unable or unwilling to provide written informed consent.
- Is, in the opinion of the Principal Investigator/s not a suitable candidate for the trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital, Department of Rheumatology Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Bionics Institute Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Austin Health - Heidelberg Repatriation Hospital Coordinator of this site? Confirm its status | Ivanhoe | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.