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
Northwell Health
10 participants
Sep 19, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria8
- 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
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Interventions
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.
The device will appear to function but no electrical stimulation will be delivered.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05583942