Vagus nerve stimulation for treating nephrotic syndrome in children
A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Frequently Relapsing Nephrotic Syndrome in Children
This study is testing whether a new treatment using vagus nerve stimulation can help children aged 3 to 17 with nephrotic syndrome feel better and reduce their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 2 sites (New Hyde Park, New York and 1 other locations) |
| Trial ID | NCT05588063 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of transcutaneous auricular vagus nerve stimulation (taVNS) as a novel treatment for children aged 3 to 17 with frequently relapsing nephrotic syndrome. The study is designed as a double-blinded, randomized, placebo-controlled trial, enrolling 30 participants who will receive either active taVNS therapy or a sham treatment for 26 weeks. Participants will monitor their heart rate and urine results, with regular in-person and virtual follow-up visits to assess treatment response and tolerability. The goal is to evaluate the feasibility of taVNS and gather preliminary data on its effectiveness in managing nephrotic syndrome in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 17 with frequently relapsing nephrotic syndrome who are currently in remission.
Not a fit: Patients with secondary forms of nephrotic syndrome or those who are steroid-dependent may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective alternative to prolonged steroid use for children with nephrotic syndrome.
How similar studies have performed: While the use of taVNS is a relatively novel approach in this context, previous studies have shown promise in using vagus nerve stimulation for other chronic immune-mediated conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * FRNS * Age 3-17 years * Glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2 * Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy) * Steroid sensitive nephrotic syndrome (prior history of remission within 4 weeks of steroid therapy) * In remission at time of enrollment (remission defined as UPC \<0.2 or negative dipstick for 3 consecutive days) * Informed consent from the parent or guardian and assent from a minor of ≥ 7. years Exclusion Criteria: * Secondary forms of nephrotic syndrome * SRNS * Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids) * Exposure to steroids within 14 days of enrollment * Receiving any standing immunosuppression (previous exposure \> 2 months allowed and/or B cell repletion) * Any known inflammatory condition (e.g. systemic lupus erythematosis) * History of cardiac disease (arrhythmias, structural/functional abnormalities) * Implantable electronic devices * Pregnancy * Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Where this trial is running
New Hyde Park, New York and 1 other locations
- Cohen Children's Medical Center — New Hyde Park, New York, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Christine B Sethna, MD, EdM
- Email: csethna@northwell.edu
- Phone: 718-470-3491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.