Using vagus nerve stimulation to treat nephrotic syndrome in children
A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Steroid Resistant Nephrotic Syndrome in Children
This study is testing if a new type of nerve stimulation can help children with steroid-resistant nephrotic syndrome feel better over 26 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | rituximab, prednisone |
| Locations | 2 sites (New Hyde Park, New York and 1 other locations) |
| Trial ID | NCT05583942 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the use of transcutaneous auricular vagus nerve stimulation (taVNS) as a novel treatment for children aged 3 to 17 with steroid-resistant nephrotic syndrome (SRNS). The study will randomly assign participants to receive either active taVNS therapy or a sham treatment over a 26-week period, with daily sessions lasting five minutes. Participants will be monitored for heart rate and urine results, with follow-up visits scheduled throughout the trial to assess treatment feasibility and response. The goal is to establish proof-of-concept for taVNS in this patient population and gather data on its potential effectiveness.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 17 diagnosed with steroid-resistant nephrotic syndrome who have not responded to steroid treatment.
Not a fit: Patients with steroid-sensitive nephrotic syndrome or secondary causes of nephrotic syndrome will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective alternative to current immunosuppressive therapies for children with nephrotic syndrome.
How similar studies have performed: While the use of taVNS is a relatively novel approach, preliminary studies in similar chronic immune-mediated conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone/prednisone at standard dose1 * Age 3-17 years * eGFR ≥30 ml/min/1.73 m2 (by modified Schwartz formula) * MCD or FSGS diagnosis (per biopsy) * Urine protein:creatinine (UPC) greater than 1.0 * Stable immunosuppression and ACE inhibitor/angiotensin receptor blocker treatment regimen for at least three months * Evidence of B cell repletion for those exposed to rituximab * Informed consent from the parent or guardian and assent from a minor of ≥ 7 years * Ability to comply with the study protocol, in the investigator's judgment Exclusion Criteria: * Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious) * Steroid sensitive nephrotic syndrome * History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 \[podocin\], NPHS1 \[nephrin\], PLCE1, WT1, or other known genetic cause) * Any known inflammatory condition * History of cardiac disease (arrhythmias, structural/functional abnormalities) * Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators) * Chronic rash or skin breakdown of the left ear at the cymba concha * Pregnancy
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.