[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Bionics Institute of Australia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":21,"type":22},5,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Arthritis, Rheumatoid",[30,31],"Neuromodulation","Inflammatory disease","RECRUITING","2025-09-18",{"date":35,"type":36},"2025-09-22","ACTUAL",{"date":38,"type":22},"2025-09",{"date":40,"type":22},"2031-12",{"name":42,"class":43},"The Bionics Institute of Australia","OTHER",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":21},"100504370","improving-early-intervention-in-hearing-impaired-children-using-functional-near-infrared-spectroscopy-fnirs-100504370","NCT05847426","Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)","The above eligibility applies to the participating audiologists who are in the experimental and control arms of the study\n\nAudiologist Inclusion Criteria:\n\n* Is a qualified audiologist who meets the criteria for membership of Audiology Australia.\n* Has at least 1 year of experience in paediatric diagnostic, hearing aid or cochlear implant audiology service provision in Australia.\n* Provides a signed and dated informed consent form.\n\nAudiologist Exclusion criteria (only for a specific infant test result):\n\n* Is the managing audiologist for the infant who's results are being provided.\n\nInfants are also recruited into the study to have an fNIRS assessment performed. They do not participate further after the fNIRS test.\n\nInfant Inclusion criteria:\n\n* Between the ages of 1 and 24 months at the time of fNIRS testing.\n* Has permanent hearing loss in one or both ears as determined by audiological diagnostic testing.\n* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nInfant Exclusion Criteria:\n\n* There are no exclusion criteria other than not meeting the inclusion criteria.",true,"24 Years",{"count":54,"type":22},40,[25],"The goal of this clinical trial is to find out whether hearing test results using functional near-infrared spectroscopy (fNIRS) will help to fast-track early intervention for infants born with a hearing loss. fNIRS is a method of imaging brain activity using light. The main questions are:\n\n1. Can audiologists make more confident decisions about the optimal interventions at different critical points in the hearing care pathway when they are given additional fNIRS information compared to when they have standard audiology test results alone?\n2. Is the experience of their infant having an fNIRS test acceptable and comfortable for the parents or care givers?",[58],"Hearing Impairment",[60,61,62],"Infants","Early intervention","functional near-infrared spectroscopy","2025-08-14",{"date":65,"type":36},"2025-08-19",{"date":67,"type":36},"2023-05-02",{"date":69,"type":22},"2028-04-28",{"name":42,"class":43},""]