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taVNS for FRNS in Children
NCT05588063 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DEVICE Sham device
- DEVICE Transcutaneous auricular vagus nerve stimulation
Study Locations (2)
New York
- Cohen Children's Medical Center — New Hyde Park
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2025-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05588063
The ClinicalTrials.gov registry entry for NCT05588063 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 371 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 2 interventions — of which Sham device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05588063 reports 2 study locations spanning 2 distinct geographic areas — top geographies include New York, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05588063 about?
NCT05588063 is a clinical study titled "taVNS for FRNS in Children". 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 ...
What is the current status of trial NCT05588063?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2023-01-05. Estimated completion is 2025-08-01.
What conditions does trial NCT05588063 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis, Minimal Change Disease, Nephrotic Syndrome in Children. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05588063?
The interventions under investigation include: Sham device (DEVICE), Transcutaneous auricular vagus nerve stimulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05588063?
This trial is sponsored by Northwell Health, which has 371 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05588063 being conducted?
This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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