Actively Recruiting
A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for Treating Frequently Relapsing Nephrotic Syndrome in Children
Led by Northwell Health · Updated on 2026-04-15
30
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Children with frequently relapsing nephrotic syndrome (FRNS) often undergo long-term treatment with steroids and other immune-suppressing drugs, which can have side effects and varying success. Researchers are evaluating a new approach using transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive therapy that may influence the immune system, aiming to assess its feasibility, tolerability, and effects on inflammatory markers in children aged 3 to 17 with FRNS. This pilot randomized controlled trial compares taVNS to a sham device to gather initial proof-of-concept data and estimate treatment effects. The study involves 30 children randomized equally to receive daily taVNS or sham therapy for 26 weeks. The device used is a handheld electrical pulse generator with a custom ear clip placed on the left ear to stimulate the vagus nerve. The active device delivers electrical pulses adjusted to each participant's tolerance, while the sham device looks identical but does not deliver stimulation. Participants perform the treatment for 5 minutes daily and monitor heart rate and urine protein at home. There is a 4-week acclimation phase and monthly monitoring through alternating in-person and virtual visits, followed by a 26-week follow-up period to assess clinical status. After the randomized phase, participants may opt to receive active taVNS in an open-label extension. Participants will attend scheduled visits for physical exams, urine and blood sample collection, and adherence checks using device usage logs. Researchers will track nephrotic syndrome relapses, adverse events, and changes in inflammatory markers. The primary outcome focuses on the success of the pilot trial through 26 weeks, with secondary outcomes including relapse rates, remission times, treatment adherence, safety, and immune markers. Participation is voluntary, with withdrawal allowed at any time, and those requiring steroid treatment during the study may be withdrawn and offered standard care alternatives.
CONDITIONS
Brief Title
taVNS for FRNS in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 17 years
- Diagnosis of frequently relapsing nephrotic syndrome (FRNS)
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73 m2 or higher
- Diagnosis of minimal change disease or focal segmental glomerulosclerosis
- Steroid sensitive nephrotic syndrome with history of remission within 4 weeks of steroid therapy
- In remission at enrollment defined by urine protein creatinine ratio below 0.2 or negative dipstick for 3 consecutive days
- Informed consent from parent or guardian and assent from children aged 7 years or older
You will not qualify if you...
- Secondary forms of nephrotic syndrome
- Steroid resistant nephrotic syndrome (SRNS)
- Steroid dependent nephrotic syndrome defined by relapse within 14 days of stopping steroids or while on steroids
- Steroid treatment within 14 days prior to enrollment
- Current use of immunosuppressive therapy (previous exposure longer than 2 months allowed)
- Any known inflammatory conditions such as systemic lupus erythematosus
- History of cardiac disease, including arrhythmias or structural abnormalities
- Presence of implantable electronic devices
- Pregnancy
- Considered likely to be non-compliant with study procedures by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 8 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility confirmation
Duration - 26 weeks
Participants perform daily transcutaneous auricular vagus nerve stimulation or sham therapy for 5 minutes each day. They are monitored monthly with alternating in-person and virtual visits to assess health, adherence, and collect samples.
3 in-person visits at Weeks 8, 16, and 26 alternating with 3 virtual video visits at Weeks 4, 12, and 20
Duration - 26 weeks
Participants are followed for an additional 26 weeks to assess clinical status with in-person or telehealth visits every 8 weeks. They may choose to receive active treatment post-trial.
Visits every 8 weeks either in-person or via telehealth
Trial Site Locations
Total: 2 locations
1
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19102
Actively Recruiting
Research Team
C
Christine B Sethna, MD, EdM
S
Suzanne Vento, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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