[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484123":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":43,"responsibleParty":94,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":33,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":46,"whyStopped":33,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Northwell Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","The intensity setting for pulse amplitude will be adjusted to the participant's tolerance (if a sensation is felt) to a maximum level of 3.",[13],"Device: trascutaneous auricular vagus nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Group","SHAM_COMPARATOR","The sham device will be altered internally so that electrical stimulation is not delivered, but the device will appear to function. Externally, the sham device will look identical to the taVNS device. The participant will be told to increase the intensity until tolerated if a sensation is felt, but will be asked to stop at a maximum level of 3.",[19],"Device: Sham device",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","trascutaneous auricular vagus nerve stimulation","The device to be used is the Roscoe Medical TENS 7000, a commercially available handheld electrical pulse generator, and an ear clip to be placed at the left ear for stimulation. Custom-made ear clips with electrode gel will be placed near the entrance to the canal of the ear to provide stimulation to the auricular branch. The handheld electrical pulse generator will be programmed to deliver electrical stimulation pulses to the cymba concha stimulating the auricular branch of the vagus nerve.",[9],[27],"Roscoe TENS 7000",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham device","The device will appear to function but no electrical stimulation will be delivered.",[15],[27],null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Christine B Sethna, MD, EdM","CONTACT","718-470-3491","csethna@northwell.edu",{"name":41,"role":37,"phone":38,"phoneExt":33,"email":42},"Suzanne Vento, RN","svento@northwell.edu",[44,78],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Cohen Children's Medical Center","RECRUITING","New Hyde Park","New York","11040","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-73.68791,40.7351,{"lat":56,"lon":55},[59,60,63,66,68,70,72,74,76],{"name":41,"role":37,"phone":38,"phoneExt":33,"email":42},{"name":61,"role":62,"phone":33,"phoneExt":33,"email":33},"Christine B Sethna, MD","PRINCIPAL_INVESTIGATOR",{"name":64,"role":65,"phone":33,"phoneExt":33,"email":33},"Kevin Tracey, MD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":33,"phoneExt":33,"email":33},"Sangeeta Chavan, PhD",{"name":69,"role":65,"phone":33,"phoneExt":33,"email":33},"Stavros Zanos, MD, PhD",{"name":71,"role":65,"phone":33,"phoneExt":33,"email":33},"Cliff Deutschman, MD, PhD",{"name":73,"role":65,"phone":33,"phoneExt":33,"email":33},"Martin Lesser, PhD",{"name":75,"role":65,"phone":33,"phoneExt":33,"email":33},"Matthew Taylor, MD",{"name":77,"role":65,"phone":33,"phoneExt":33,"email":33},"Joanna Fishbein, MS",{"facility":79,"status":46,"city":80,"state":81,"zip":82,"country":50,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":53,"coordinates":84},[85,86],-75.16362,39.95238,{"lat":86,"lon":85},[89,93],{"name":90,"role":37,"phone":91,"phoneExt":33,"email":92},"Kevin Meyers, MD","215-590-2449","meyersk@chop.edu",{"name":90,"role":62,"phone":33,"phoneExt":33,"email":33},{"type":95,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[97],{"name":98,"class":99},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100484123","a-pilot-trial-of-tavns-for-srns-in-children-kidney-vns-100484123",false,"NCT05583942","A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)","A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Steroid Resistant Nephrotic Syndrome in Children","kidNEY-VNS","Inclusion Criteria:\n\n* Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone\u002Fprednisone at standard dose1\n* Age 3-17 years\n* eGFR ≥30 ml\u002Fmin\u002F1.73 m2 (by modified Schwartz formula)\n* MCD or FSGS diagnosis (per biopsy)\n* Urine protein:creatinine (UPC) greater than 1.0\n* Stable immunosuppression and ACE inhibitor\u002Fangiotensin receptor blocker treatment regimen for at least three months\n* Evidence of B cell repletion for those exposed to rituximab\n* Informed consent from the parent or guardian and assent from a minor of ≥ 7 years\n* Ability to comply with the study protocol, in the investigator's judgment\n\nExclusion Criteria:\n\n* Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious)\n* Steroid sensitive nephrotic syndrome\n* History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 \\[podocin\\], NPHS1 \\[nephrin\\], PLCE1, WT1, or other known genetic cause)\n* Any known inflammatory condition\n* History of cardiac disease (arrhythmias, structural\u002Ffunctional abnormalities)\n* Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators)\n* Chronic rash or skin breakdown of the left ear at the cymba concha\n* Pregnancy","ALL","3 Years","17 Years",{"count":112,"type":113},10,"ESTIMATED","INTERVENTIONAL",[116],"NA","Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated noninvasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.",[119,120,121],"Nephrotic Syndrome in Children","Minimal Change Disease","Focal Segmental Glomerulosclerosis",[123,124,125],"vagus nerve stimulation","pediatric","nephrology","2026-04-14",{"date":128,"type":129},"2026-04-17","ACTUAL",{"date":131,"type":129},"2022-09-19",{"date":133,"type":113},"2027-08-01",{"name":5,"class":6},2]