RECRUITING

taVNS for FRNS in Children

Conditions

Nephrotic Syndrome in Children Minimal Change Disease Focal Segmental Glomerulosclerosis vagus nerve stimulation pediatric nephrology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-05

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05588063

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.

Ages Eligible for Study:3 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Christine B Sethna, MD, EdM

CONTACT

718-470-3491

csethna@northwell.edu

Suzanne Vento, RN

CONTACT

718-470-3491

svento@northwell.edu

Study Locations (Sites)

Cohen Children's Medical Center

New Hyde Park, New York, 11040

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19102

United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-05

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2023-01-05

Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

vagus nerve stimulation
pediatric
nephrology

Additional Relevant MeSH Terms

Nephrotic Syndrome in Children
Minimal Change Disease
Focal Segmental Glomerulosclerosis