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

NCT07017686 | Recruiting

• 2 other identifiers: 107360122/24
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Arthritis, Rheumatoid

Keywords

Neuromodulation; Inflammatory disease

Outcome Measures

Primary Outcomes (3)

• Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.

  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.

  24 weeks

• Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.

  No significant increase in electrically Evoked Compound Action Potentials (ECAPs) threshold

  24 weeks

• Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.

  No significant decrease in amplitude of electrically Evoked Compound Action Potentials (ECAPs)

  24 weeks

Secondary Outcomes (1)

• Performance of the aVNS System.

  24 weeks

Other Outcomes (1)

• Exploratory Outcome: Non-futile benefits of aVNS in individuals with drug refractory moderate-severe adult-onset RA.

  Baseline to week 6, 12 or 24 assessment.

Study Arms (1)

abdominal vagus nerve stimulation (aVNS)

EXPERIMENTAL

Participants will receive aVNS, delivered by the implanted aVNS device.

Device: abdominal vagus nerve stimulation (aVNS)

Interventions

abdominal vagus nerve stimulation (aVNS) DEVICE

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.

Also known as: IBDStim, Vagus Nerve Stimulator

abdominal vagus nerve stimulation (aVNS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable or unwilling to provide written informed consent.
• 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 previous surgical interventions including vagotomy, splenectomy, bariatric surgery.
• History of gastric hiatus hernia.
• 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.
• A condition that requires routine Magnetic Resonance Imaging (MRI) scans
• Is, in the opinion of the Principal Investigator/s not a suitable candidate for the trial.

Sponsors & Collaborators

• The Bionics Institute of Australia: lead
• St Vincent's Hospital Melbourne: collaborator
• Austin Health: collaborator

Study Sites (3)

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

Related Publications (4)

• Payne, S. C., Burns, O., Stebbing, M., Thomas, R., Silva, A. de, Sedo, A., … Shepherd, R. K. (2018). Vagus Nerve Stimulation to Treat Inflammatory Bowel Disease: A Chronic, Preclinical Safety Study in Sheep. Bioelectronics in Medicine, 1(4), 235-250. https://doi.org/10.2217/bem-2018-0011

  BACKGROUND

• Payne SC, Furness JB, Stebbing MJ. Bioelectric neuromodulation for gastrointestinal disorders: effectiveness and mechanisms. Nat Rev Gastroenterol Hepatol. 2019 Feb;16(2):89-105. doi: 10.1038/s41575-018-0078-6.

  PMID: 30390018 BACKGROUND

• Payne SC, Furness JB, Burns O, Sedo A, Hyakumura T, Shepherd RK, Fallon JB. Anti-inflammatory Effects of Abdominal Vagus Nerve Stimulation on Experimental Intestinal Inflammation. Front Neurosci. 2019 May 8;13:418. doi: 10.3389/fnins.2019.00418. eCollection 2019.

  PMID: 31133776 BACKGROUND

• Payne SC, Romas E, Hyakumura T, Muntz F, Fallon JB. Abdominal vagus nerve stimulation alleviates collagen-induced arthritis in rats. Front Neurosci. 2022 Nov 21;16:1012133. doi: 10.3389/fnins.2022.1012133. eCollection 2022.

  PMID: 36478876 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• A/Prof Shereen Oon

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A/Prof Shereen Oon, MBBS, PhD

CONTACT

+61392311203; rheumclintrials@svha.org.au

Angela Chia, RN

CONTACT

+61392311203; rheumclintrials@svha.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive abdominal vagus nerve stimulation (aVNS), delivered by an implanted medical device consisting of an electrode array attached to the abdominal vagus nerve and implantable battery placed under the skin.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)