Actively Recruiting
The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
Led by The Bionics Institute of Australia · Updated on 2025-09-22
5
Participants Needed
3
Research Sites
326 weeks
Total Duration
On this page
Sponsors
T
The Bionics Institute of Australia
Lead Sponsor
S
St Vincent's Hospital Melbourne
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Adult-onset rheumatoid arthritis (onset at age 18 or above) confirmed by 2010 ACR/EULAR criteria and positive Rheumatoid Factor or specific antibody tests
- Moderate to severe active RA with at least 4 tender and 4 swollen joints out of 28
- Active disease not responding to a 3-month trial or intolerant to at least 2 biologic or targeted synthetic DMARDs
- Stable dose of at least one biological or synthetic DMARD for more than 8 weeks before screening and during the trial
- Women of childbearing potential must not be pregnant or trying to become pregnant and agree to use effective contraception
- Eligibility for Medicare
- Ability to provide informed consent by signing a consent form
You will not qualify if you...
- Unable or unwilling to provide written informed consent
- Current major psychiatric disorder except stable, well-controlled major depression or anxiety
- Medical conditions interfering with study procedures or endpoint evaluation
- Severe autonomic neuropathy such as poorly controlled type 2 diabetes or metabolic disease
- History of previous surgeries including vagotomy, splenectomy, or bariatric surgery
- History of gastric hiatus hernia
- Previously implanted active medical devices or likely need for such devices within 6 months
- Conditions requiring routine MRI scans
- Considered unsuitable for the trial by the Principal Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Bionics Institute
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
2
St Vincent's Hospital, Department of Rheumatology
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
3
Austin Health, Heidelberg Repatriation Hospital
Ivanhoe, Victoria, Australia, 3079
Actively Recruiting
Research Team
A
A/Prof Shereen Oon, MBBS, PhD
CONTACT
A
Angela Chia, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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