RECRUITING

A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)

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 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.

Official Title

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

Quick Facts

Study Start:2022-09-19
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05583942

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 CriteriaExclusion Criteria
  1. * Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone/prednisone at standard dose1
  2. * Age 3-17 years
  3. * eGFR ≥30 ml/min/1.73 m2 (by modified Schwartz formula)
  4. * MCD or FSGS diagnosis (per biopsy)
  5. * Urine protein:creatinine (UPC) greater than 1.0
  6. * Stable immunosuppression and ACE inhibitor/angiotensin receptor blocker treatment regimen for at least three months
  7. * Evidence of B cell repletion for those exposed to rituximab
  8. * Informed consent from the parent or guardian and assent from a minor of ≥ 7 years
  9. * Ability to comply with the study protocol, in the investigator's judgment
  1. * Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious)
  2. * Steroid sensitive nephrotic syndrome
  3. * History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 \[podocin\], NPHS1 \[nephrin\], PLCE1, WT1, or other known genetic cause)
  4. * Any known inflammatory condition
  5. * History of cardiac disease (arrhythmias, structural/functional abnormalities)
  6. * Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators)
  7. * Chronic rash or skin breakdown of the left ear at the cymba concha
  8. * Pregnancy

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, 19104
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 Date2022-09-19
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2022-09-19
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