taVNS for FRNS in Children

Description

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.

Conditions

Nephrotic Syndrome in Children, Minimal Change Disease, Focal Segmental Glomerulosclerosis

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Study Overview

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Study Details

Study overview

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.

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

taVNS for FRNS in Children

Condition
Nephrotic Syndrome in Children
Intervention / Treatment

-

Contacts and Locations

New Hyde Park

Cohen Children's Medical Center, New Hyde Park, New York, United States, 11040

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * FRNS
  • * Age 3-17 years
  • * Glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2
  • * Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy)
  • * Steroid sensitive nephrotic syndrome (prior history of remission within 4 weeks of steroid therapy)
  • * In remission at time of enrollment (remission defined as UPC \<0.2 or negative dipstick for 3 consecutive days)
  • * Informed consent from the parent or guardian and assent from a minor of ≥ 7. years
  • * Secondary forms of nephrotic syndrome
  • * SRNS
  • * Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids)
  • * Exposure to steroids within 14 days of enrollment
  • * Receiving any standing immunosuppression (previous exposure \> 2 months allowed and/or B cell repletion)
  • * Any known inflammatory condition (e.g. systemic lupus erythematosis)
  • * History of cardiac disease (arrhythmias, structural/functional abnormalities)
  • * Implantable electronic devices
  • * Pregnancy
  • * Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Ages Eligible for Study

3 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwell Health,

Study Record Dates

2025-08-01