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

NCT ID
NCT07017686
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
The Bionics Institute of Australia
Conditions
Arthritis, Rheumatoid

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: The Reboot Study: A Single Group, Open Label Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis

Enrollment: 5 participants (Estimated).

What is being studied

  • Device: abdominal vagus nerve stimulation (aVNS)

Who may be eligible

Ages
18 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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.

Study locations

3 study locations are listed.

Recruiting site status is explicitly provided for 3 locations; 3 are listed as Recruiting.

Countries: Australia

  • Victoria, Australia: 3

Sample of listed locations

  • Bionics Institute — Fitzroy, Victoria, 3065, Australia — Recruiting
  • St Vincent's Hospital, Department of Rheumatology — Fitzroy, Victoria, 3065, Australia — Recruiting
  • Austin Health, Heidelberg Repatriation Hospital — Ivanhoe, Victoria, 3079, Australia — Recruiting

Study details

Start date
August 11, 2026
Primary completion date
September 1, 2027
Completion date
December 1, 2031
First posted
June 12, 2025
Collaborators
Austin Health, St Vincent's Hospital Melbourne

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07017686
Registry last updated
October 2, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07017686 on ClinicalTrials.gov

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