What is transcutaneous auricular vagus nerve stimulation (taVNS) studying for steroid resistant nephrotic syndrome in children?

This study is evaluating taVNS as a potential treatment for children with steroid resistant nephrotic syndrome. Researchers want to see if daily stimulation of the vagus nerve can be safely used and how it affects disease activity and inflammation. The study is sponsored by Northwell Health and aims to explore a new therapy option for this challenging condition.

Who may be eligible for this nephrotic syndrome clinical trial?

Children aged 3 to 17 years with steroid resistant nephrotic syndrome may be eligible. They must have confirmed diagnoses like minimal change disease or focal segmental glomerulosclerosis, stable kidney function, and be off steroids for at least 14 days. Children with certain genetic causes or heart disease cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this nephrotic syndrome clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel costs may vary and are not guaranteed to be covered. Participants and families should plan accordingly for any expenses related to travel or accommodations.

Actively Recruiting

Phase Not Applicable

Age: 3Years - 17Years

All Genders

ID05583942

Pilot Study of Noninvasive Vagus Nerve Stimulation for Treating Steroid Resistant Nephrotic Syndrome in Children Aged 3 to 17

Led by Northwell Health · Updated on 2026-04-17

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the use of transcutaneous auricular vagus nerve stimulation taVNS as a new treatment option for children aged 3 to 17 years with steroid resistant nephrotic syndrome SRNS. Children with SRNS often face long-term use of immunosuppressant medications that can have side effects and uncertain benefits. The study focuses on the safety, feasibility, and potential effects of taVNS on immune-related inflammation in this condition. Participants will be randomly assigned to receive either active taVNS or a sham version of the device that looks identical but does not deliver electrical stimulation. Each child will use the device for 5 minutes daily over 26 weeks. The taVNS device sends gentle electrical pulses to the ears vagus nerve branch. The study includes a screening period, a 26-week randomized treatment phase with monthly in-person and virtual visits, and a 26-week follow-up period to monitor clinical outcomes. After the randomized phase, participants can choose to continue active taVNS in an open-label extension. During the study, children will log heart rate and urine protein levels daily and attend regular visits for physical exams, blood and urine tests, and adherence checks. Researchers will assess kidney function, protein in urine, quality of life, inflammatory markers, and treatment tolerability. Safety and side effects will be monitored throughout. The overall participation lasts up to about 60 weeks, including screening, treatment, and follow-up periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Children aged 3 to 17 years
Diagnosed with steroid resistant nephrotic syndrome (no remission after 4 weeks of standard steroid therapy)
Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73 m2 or higher
Diagnosis of minimal change disease or focal segmental glomerulosclerosis confirmed by biopsy
Urine protein to creatinine ratio (UPC) greater than 1.0
Stable immunosuppression and ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months
Evidence of B cell recovery if previously treated with rituximab
Informed consent from parent or guardian and assent from children aged 7 years or older
Ability to follow the study protocol as judged by the investigator

You will not qualify if you...

Secondary causes of nephrotic syndrome such as genetic, congenital, or infectious origins
Steroid sensitive nephrotic syndrome
Known genetic defects causing nephrotic syndrome (e.g., NPHS2, NPHS1, PLCE1, WT1)
Any known inflammatory condition
History of cardiac disease including arrhythmias or structural abnormalities
Presence of implantable electronic devices such as pacemakers or cochlear implants
Chronic rash or skin breakdown on the left ear where stimulation is applied
Pregnancy

Research Team

Christine B Sethna, MD, EdM

Suzanne Vento, RN

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