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Study of taVNS for Frequently Relapsing Nephrotic Syndrome in Children

This study is looking at a device called transcutaneous auricular vagus nerve stimulation (taVNS) for children aged 3 to 17 who have frequently relapsing nephrotic syndrome (FRNS). FRNS is a kidney condition where the body loses too much protein in the urine, and it often comes back. The taVNS device, Roscoe Medical TENS 7000, delivers a small electrical pulse to the ear. Researchers want to see if this device can help reduce relapses and if it's a safe option, as current treatments can have side effects. To join, children must have FRNS, a specific kidney function (eGFR ≥30 ml/min/1.73 m2), and have responded to steroids before. The main goal is to see if this pilot study is successful over 26 weeks.

Study design
This is a double-blind, randomized, placebo-controlled study comparing daily taVNS with a sham device. About 30 children will be enrolled and randomly assigned to receive either the active device or a device that looks the same but doesn't deliver electrical stimulation.
What's involved
Participants will use the device daily for 5 minutes over 26 weeks. You will have in-person visits at weeks 8, 16, and 26, and virtual visits at weeks 4, 12, and 20. Biosamples will be collected at baseline, 8, 16, and 26 weeks.
Compensation
Not stated in the trial record.
Follow-up
After the 26-week treatment period, there will be an additional 26-week follow-up period.

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NCT05588063

taVNS for FRNS in Children

Recruiting
NAAges 3–17InterventionalTreatment
Northwell Health
~30 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Transcutaneous auricular vagus nerve stimulationSham device

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Success of Pilot Trial
Measured over Baseline through 26 weeks

Conditions

Nephrotic Syndrome in Children
Minimal Change Disease
Focal Segmental Glomerulosclerosis

Explore related trials

Focal Segmental GlomerulosclerosisMinimal Change GlomerulonephritisNephrotic Syndrome

Where it's being run

2 sites across 2 states
New York1
Pennsylvania1

Who to contact

Christine B Sethna, MD, EdM
[email protected]
718-470-3491
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Success of Pilot TrialBaseline through 26 weeks

    1. Unsuccessful, main study not practicable (1) None of the benchmarks are met, or (2) One or more of the benchmarks are not met and there is low likelihood of reaching benchmarks even with protocol modifications or (3) Serious adverse events related to the treatment. 2. Probable Success main study practicable with modifications to protocol. One or more of the benchmarks are not met, but there is a high likelihood that the benchmark can be met with protocol modifications. 3. Successful main study practicable without modifications. All of the benchmarks are met.