Study of Non-Invasive Vagus Nerve Stimulation to Treat Frequently Relapsing Nephrotic Syndrome in Children Aged 3 to 17

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 participants 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is voluntary, with withdrawal allowed at any time, and those requiring steroid treatment during the study may be withdrawn and offered standard care alternatives.

taVNS for FRNS in Children