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Currently Enrolling
Interventional

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 Phone
Site 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

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Find other locations for this trial:
Currently Enrolling
Interventional

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.

Find other locations for this trial:
Philadelphia PA (Children's Hospital of Philadelphia- Main)
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

Clinical studies are any studies that involve people. There are two main types: observational and interventional. In an observational trial, researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease. In an interventional trial, participants receive specific interventions, which can include new treatments or behavorial changes (e.g., diet changes). To learn more about clinical research, please visit the NephCure website.

See other frequently asked questions