RecruitingNot ApplicableNCT05583942

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


Sponsor

Northwell Health

Enrollment

10 participants

Start Date

Sep 19, 2022

Study Type

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

Min Age: 3 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

Steroid-resistant nephrotic syndrome (SRNS) is a kidney condition where the usual steroid treatment does not work, causing the kidneys to leak too much protein. This pilot study tests whether gentle electrical stimulation of the ear (called transcutaneous auricular vagus nerve stimulation, or taVNS) can help reduce protein leakage in children with SRNS. You may be eligible if: - Your child has steroid-resistant nephrotic syndrome - Your child is between 3 and 17 years old - Your child has a kidney biopsy confirming MCD or FSGS - Your child's kidney function (eGFR) is at least 30 - Your child has been on a stable medication regimen for at least 3 months You may NOT be eligible if: - Your child's nephrotic syndrome has a known genetic, congenital, or infectious cause - Your child has a heart condition or any implanted electronic device (pacemaker, cochlear implant, etc.) - Your child has a skin rash or breakdown on the left ear - Your child is pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtrascutaneous 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.

DEVICESham device

The device will appear to function but no electrical stimulation will be delivered.


Locations(2)

Cohen Children's Medical Center

New Hyde Park, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT05583942


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