Arthritis, RheumatoidRebootNCT07017686
The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
A study testing abdominal vagus nerve stimulation (aVNS) in people with Arthritis, Rheumatoid, run by The Bionics Institute of Australia at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- abdominal vagus nerve stimulation (aVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesAustralia
- Study dates
- 11 Aug 2026to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Bionics Institute
Fitzroy, Victoria, 3065
- Recruiting
St Vincent's Hospital, Department of Rheumatology
Fitzroy, Victoria, 3065
- Recruiting
Austin Health, Heidelberg Repatriation Hospital
Ivanhoe, Victoria, 3079
About this study
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
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 the detailed description
This open label first-in-indication study will assess safety of an abdominal vagus nerve stimulation (aVNS) device in 5 adult participants with moderate to severe drug refractory rheumatoid arthritis (RA). The trial primary objectives at 24 weeks are to assess: 1) safety of aVNS and; 2) device performance. An exploratory objective is to assess non-futile benefits of aVNS at 12 and 24 weeks. During the initial phase of the study (2-24 weeks), stimulation will be delivered for 3 hours per day, with the participant switching the device on and off via a controller. Reports of safety, device checks and clinical assessment of RA symptoms will occur during at 2-, 6-, 12- and 24-weeks post-surgery. Participants that complete the initial phase of the study (24 week assessment) will have the option to continue using the device. Participants that do not want to continue treatment, or withdraw, will have their device deactivated. The device will remain implanted unless there is a clinical reason to remove it or if the participant requests removal. During the follow up phase of the safety trial (24-265 weeks), participants will be monitored twice a year for up to 5 years. The total duration of involvement of participants will be approximately 5 years.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- abdominal vagus nerve stimulation (aVNS)
- Keywords
- Neuromodulation, Inflammatory disease
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal vagus nerve stimulation (aVNS)Device
Also called IBDStim, Vagus Nerve Stimulator
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.
| Study group | Role | What they receive |
|---|---|---|
| abdominal vagus nerve stimulation (aVNS) | Experimental | Participants will receive aVNS, delivered by the implanted aVNS device. Receives: Device: abdominal vagus nerve stimulation (aVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 24 weeks
Secondary outcomes (1)
Performance of the aVNS System.
Rate of device deficiencies less than that for the Evoke® device
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start11 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Bionics Institute of Australia
- Sponsor type
- University, hospital or other
- Collaborators
- St Vincent's Hospital Melbourne, Austin Health
- Responsible party
- Sponsor
- Investigators
- A/Prof Shereen Oon, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017686
- Sponsor's protocol ID
- 107360
- Other IDs
- 122/24
- Acronym
- Reboot
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 30390018Payne 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.
PubMed 31133776Payne 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.
PubMed 36478876
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07017686
- Acronym / sponsor ID
- Reboot / 107360
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Neuromodulation, Inflammatory disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- The Bionics Institute of AustraliaUniversity, hospital or other
- Collaborators
- St Vincent's Hospital Melbourne, Austin Health
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This open label first-in-indication study will assess safety of an abdominal vagus nerve stimulation (aVNS) device in 5 adult participants with moderate to severe drug refractory rheumatoid arthritis (RA). The trial primary objectives at 24 weeks are to assess: 1) safety of aVNS and; 2) device performance. An exploratory objective is to assess non-futile benefits of aVNS at 12 and 24 weeks. During the initial phase of the study (2-24 weeks), stimulation will be delivered for 3 hours per day, with the participant switching the device on and off via a controller. Reports of safety, device checks and clinical assessment of RA symptoms will occur during at 2-, 6-, 12- and 24-weeks post-surgery. Participants that complete the initial phase of the study (24 week assessment) will have the option to continue using the device. Participants that do not want to continue treatment, or withdraw, will have their device deactivated. The device will remain implanted unless there is a clinical reason to remove it or if the participant requests removal. During the follow up phase of the safety trial (24-265 weeks), participants will be monitored twice a year for up to 5 years. The total duration of involvement of participants will be approximately 5 years.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| abdominal vagus nerve stimulation (aVNS) | Experimental | Device: abdominal vagus nerve stimulation (aVNS)Participants will receive aVNS, delivered by the implanted aVNS device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal vagus nerve stimulation (aVNS)Also: IBDStim, Vagus Nerve StimulatorParticipants 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. | Device | abdominal vagus nerve stimulation (aVNS) |
Primary outcome
Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.
Time frame: 24 weeks
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.
Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.
Time frame: 24 weeks
No significant increase in electrically Evoked Compound Action Potentials (ECAPs) threshold
Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA.
Time frame: 24 weeks
No significant decrease in amplitude of electrically Evoked Compound Action Potentials (ECAPs)
1 secondary outcome
Performance of the aVNS System.
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- BackgroundPayne, 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: PubMed 30390018Payne 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.
- Background: PubMed 31133776Payne 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.
- Background: PubMed 36478876Payne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
A/Prof Shereen Oon principal investigator
St Vincent's Hospital Melbourne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal vagus nerve stimulation (aVNS) in people with Arthritis, Rheumatoid, run by The Bionics Institute of Australia at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A/Prof Shereen Oon, MBBS, PhD (+61392311203, rheumclintrials@svha.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of aVNS in individuals with drug refractory moderate-severe adult-onset RA. (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017686, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.