[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594303":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":65,"collaborators":67,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":39,"whyStopped":32,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"The Bionics Institute of Australia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"abdominal vagus nerve stimulation (aVNS)","EXPERIMENTAL","Participants will receive aVNS, delivered by the implanted aVNS device.",[13],"Device: abdominal vagus nerve stimulation (aVNS)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"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.",[9],[20,21],"IBDStim","Vagus Nerve Stimulator",[23],{"name":24,"affiliation":25,"role":26},"A\u002FProf Shereen Oon","St Vincent's Hospital Melbourne","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"A\u002FProf Shereen Oon, MBBS, PhD","CONTACT","+61392311203",null,"rheumclintrials@svha.org.au",{"name":35,"role":30,"phone":31,"phoneExt":32,"email":33},"Angela Chia, RN",[37,51,56],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":32},"Bionics Institute","RECRUITING","Fitzroy","Victoria","3065","Australia","AU",{"type":46,"coordinates":47},"Point",[48,49],144.97833,-37.79839,{"lat":49,"lon":48},{"facility":52,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":53,"geoPoint":55,"contacts":32},"St Vincent's Hospital, Department of Rheumatology",{"type":46,"coordinates":54},[48,49],{"lat":49,"lon":48},{"facility":57,"status":39,"city":58,"state":41,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":32},"Austin Health, Heidelberg Repatriation Hospital","Ivanhoe","3079",{"type":46,"coordinates":61},[62,63],145.04308,-37.76903,{"lat":63,"lon":62},{"type":66,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[68,69],{"name":25,"class":6},{"name":70,"class":71},"Austin Health","OTHER_GOV","100594303","the-reboot-study-a-safety-study-of-abdominal-vagus-nerve-stimulation-for-moderate-to-severe-drug-refractory-rheumatoid-arthritis-100594303",false,"NCT07017686","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","Reboot","Inclusion Criteria:\n\n1. Male or female (18 - 75 years of age).\n2. Adult-onset rheumatoid arthritis (RA) (onset age 18 years or above) as defined by the 2010 ACR\u002FEULAR classification criteria, and Rheumatoid Factor (RF) or Cyclic Citrullinated Peptide (CCP) Antibody\u002FAnti-Citrullinated Peptide Antibody (ACPA) must be positive (above lab ranges).\n3. Moderate-severe active RA defined by at least 4\u002F28 tender and 4\u002F28 swollen joints.\n4. 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\u002For new targeted synthetic DMARDs (e.g. JAK inhibitors).\n5. Using a stable, continuous dose of at least 1 biological and\u002For synthetic DMARD for \\>8 weeks prior to study screening and for the duration of the trial.\n6. 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.\n7. Medicare eligibility.\n8. Provision of informed consent, in the form of a signed and dated informed consent form.\n\nExclusion Criteria:\n\n1. Unable or unwilling to provide written informed consent.\n2. Current diagnosis of major psychiatric disorder\u002Fs, or meets criteria as such on the Mini International Neuropsychiatric Interview (MINI), with the exception of stable, well controlled Major Depression or Anxiety Disorder.\n3. A medical condition that could interfere with study procedures, and\u002For confound evaluation of study endpoints, as determined by the Investigator.\n4. Medical conditions that have resulted in severe autonomic neuropathy e.g. poorly controlled type 2 diabetes or metabolic disease.\n5. History of previous surgical interventions including vagotomy, splenectomy, bariatric surgery.\n6. History of gastric hiatus hernia.\n7. 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.\n8. A condition that requires routine Magnetic Resonance Imaging (MRI) scans\n9. Is, in the opinion of the Principal Investigator\u002Fs not a suitable candidate for the trial.","ALL","18 Years","75 Years",{"count":84,"type":85},5,"ESTIMATED","INTERVENTIONAL",[88],"NA","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.",[91],"Arthritis, Rheumatoid",[93,94],"Neuromodulation","Inflammatory disease","2025-09-18",{"date":97,"type":98},"2025-09-22","ACTUAL",{"date":100,"type":85},"2025-09",{"date":102,"type":85},"2031-12",{"name":5,"class":6},3]