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

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.

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