Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
kidNEY-VNS for FRNS
Transcutaneous Vagus Nerve Stimulation for the Treatment of Idiopathic Nephrotic Syndrome in Children: A Pilot Feasibility Study
Brief Description
This study seeks to explore taVNS as a potential, novel treatment for children with frequently relapsing nephrotic syndrome (FRNS).
Trial Physician / Study Coordinator
Christine B Sethna, MD, EdM
Email PhoneSite Name
Children's Hospital of Philadelphia
Sponsor
Northwell Health
Study Drug
Transcutaneous Vagus Nerve Stimulation (taVNS)
Estimated enrollment
30 patients
Estimated end date
08/01/2025
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
kidNEY-VNS for FRNS
Transcutaneous Vagus Nerve Stimulation for the Treatment of Idiopathic Nephrotic Syndrome in Children: A Pilot Feasibility Study
Brief Description
This study seeks to explore taVNS as a potential, novel treatment for children with frequently relapsing nephrotic syndrome (FRNS).
Trial is for people with
Frequently relapsing nephrotic syndrome (FRNS), minimal change disease (MCD), or focal segmental glomerulosclerosis (FSGS)
Study Goal
The goal of this study is to investigate the efficacy of taVNS in the treatment of FRNS in children.
What is involved for the Patient?
If eligible, patients will be asked to use the device twice daily for ten minutes and monitor urine at home with a urine dipstick. Patients will also be monitored monthly with in-person and remote visits which can be scheduled in conjunction with normally scheduled appointments, if possible. At each in-person visit, the study team may also collect standard of care and research labs.
About the drug or intervention
The device used is the Roscoe Medical TENS 7000, a commercially available electrical pulse generator, and an ear clip to be placed at the left ear for stimulation. The ear electrodes are made of carbon loaded silicone (510k K062284) which allow for conduction. The ear clips are made with commercially available electrodes at The Feinstein Institute. All participants will be given electrode gel (Spectra 360 12-08 Electrode Gel, Parker Laboratories) which will be placed on the ear electrodes prior to placement at the cymba concha.