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Pilot Trial of taVNS for Steroid Resistant Nephrotic Syndrome in Children

This study is a pilot trial for children aged 3 to 17 with Steroid Resistant Nephrotic Syndrome (SRNS), a kidney condition where standard steroid treatment hasn't worked. It's looking at a new approach called transcutaneous auricular vagus nerve stimulation (taVNS), which uses a device placed on the ear to stimulate a nerve. This nerve stimulation might help reduce inflammation. The study will compare daily taVNS with a sham device (which looks and feels like it's working but doesn't deliver electrical stimulation). The goal is to see if taVNS is a successful and safe treatment option for these children. We plan to enroll 10 participants, and the current status of the study is unclear.

Study design
This is a double-blinded, randomized, placebo-controlled pilot trial. It will compare daily taVNS with a sham device in 10 participants.
What's involved
You would perform daily taVNS or sham therapy for 5 minutes each day for 26 weeks. There will be monthly in-person or virtual visits, and biosamples will be collected at specific times.
Compensation
Not stated in the trial record.
Follow-up
There will be an additional 26-week follow-up period after the 26 weeks of daily therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05583942

A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)

Recruiting
NAAges 3–17InterventionalTreatment
Northwell Health
~10 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:trascutaneous 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 to 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

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

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

What this trial measures

  • Success of Pilot TrialBaseline to 26 weeks

    1. Unsuccessful: main study not practicable 1. None of the primary feasibility and tolerability benchmarks are met, or 2. One or more of the primary 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 primary 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 primary benchmarks are met.