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NCT05588063 · ClinicalTrials.gov registry record · NA
taVNS for FRNS in Children
A NA study of Focal Segmental Glomerulosclerosis and Minimal Change Disease, sponsored by Northwell Health.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT05588063 is a NA study of Focal Segmental Glomerulosclerosis and Minimal Change Disease that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 30 participants, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05588063, a NA study of Focal Segmental Glomerulosclerosis and Minimal Change Disease, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (87% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
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.
NCT05588063 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Pennsylvania.
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.
What interventions are being tested in trial NCT05588063?
The interventions under investigation include: Sham device (DEVICE), Transcutaneous auricular vagus nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT05588063?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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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