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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
Who can join
Ages 3 to 17 · All sexes
Full eligibility criteria
Inclusion Criteria: * Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone/prednisone at standard dose1 * Age 3-17 years * eGFR ≥30 ml/min/1.73 m2 (by modified Schwartz formula) * MCD or FSGS diagnosis (per biopsy) * Urine protein:creatinine (UPC) greater than 1.0 * Stable immunosuppression and ACE inhibitor/angiotensin receptor blocker treatment regimen for at least three months * Evidence of B cell repletion for those exposed to rituximab * Informed consent from the parent or guardian and assent from a minor of ≥ 7 years * Ability to comply with the study protocol, in the investigator's judgment Exclusion Criteria: * Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious) * Steroid sensitive nephrotic syndrome * History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 \[podocin\], NPHS1 \[nephrin\], PLCE1, WT1, or other known genetic cause) * Any known inflammatory condition * History of cardiac disease (arrhythmias, structural/functional abnormalities) * Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators) * Chronic rash or skin breakdown of the left ear at the cymba concha * Pregnancy
About the study
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.
What is being tested
- trascutaneous auricular vagus nerve stimulation (device)
- Sham device (device)
Sponsor: Northwell Health · Participants: 10 · Started: Sep 19, 2022
Contact the study team
- Christine B Sethna, MD, EdM · Phone: 718-470-3491
- Suzanne Vento, RN · Phone: 718-470-3491
Official record on ClinicalTrials.gov — NCT05583942
Locations in the U.S.
| New York | Cohen Children's Medical Center, New Hyde Park |
| Pennsylvania | Children's Hospital of Philadelphia, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.