RecruitingNot ApplicableNCT05588063

taVNS for FRNS in Children

A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Frequently Relapsing Nephrotic Syndrome in Children


Sponsor

Northwell Health

Enrollment

30 participants

Start Date

Jan 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Children with frequently relapsing nephrotic syndrome (FRNS) are exposed to prolonged courses of steroids and other 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 non invasively 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

This study tests a non-invasive nerve stimulation technique called taVNS (transcutaneous auricular vagus nerve stimulation) — a gentle electrical pulse applied to the ear — to see if it can reduce how often children with a kidney condition called Frequently Relapsing Nephrotic Syndrome (FRNS) have relapses. The goal is to find a drug-free way to help the kidneys stay in remission longer. You may be eligible if: - Your child is between 3 and 17 years old - Your child has been diagnosed with Frequently Relapsing Nephrotic Syndrome (FRNS) - Your child has Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS) - Your child's kidneys respond to steroid treatment (steroid-sensitive) - Your child is currently in remission (protein levels in urine are very low) - Your child has adequate kidney function (eGFR ≥30 ml/min/1.73 m²) You may NOT be eligible if: - Your child has a secondary cause of nephrotic syndrome (caused by another disease) - Your child's nephrotic syndrome does not respond to steroids - Your child is currently on immunosuppressive medications - Your child has a known inflammatory condition such as lupus - Your child has a history of heart problems or an implantable electronic device - 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

DEVICETranscutaneous 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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NCT05588063


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