Effect of Daily Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Proteinuria in Pediatric Patients With Idiopathic Nephrotic Syndrome
Condition: Idiopathic Nephrotic Syndrome; Frequently Relapsing Nephrotic Syndrome
MeSH terms: Proteinuria; Nephrotic Syndrome; Nephrosis; Nephrosis, Lipoid; Syndrome
Study type: Interventional

Summary: 
      This study evaluates the impact of transcutaneous auricular Vagus Nerve stimulation (taVNS)
      therapy on the incidence of nephrotic syndrome relapses in children with idiopathic nephrotic
      syndrome. Participants will perform taVNS 5 minutes a day for 6 months total, monitoring for
      signs of nephrotic syndrome relapse with both labwork and clinical symptoms.
    

Detailed description: 
      Idiopathic nephrotic syndrome is defined as the development of proteinuria, edema,
      hypoalbuminemia, and hyperlipidemia often presenting in the pediatric population. The
      underlying pathogenesis of idiopathic nephrotic syndrome is poorly understood but likely
      involves dysregulation of the immune system, and the majority of patients respond to steroid
      therapy and other immunosuppressive therapy. Unfortunately, relapses are common, with at
      least one relapse occurring in up to 90% of patients. Frequently-relapsing patients may be
      exposed large amounts of steroids and other immunosuppressants with a multitude of adverse
      effects, while others may not even respond to these treatments. Therefore, novel therapies
      are being studied.

      Vagus nerve stimulation is a novel therapy with the potential to treat inflammatory
      conditions via inhibition of cytokine release by the cholinergic anti-inflammatory pathway.
      The purpose of the proposed study is to investigate the use of vagus nerve stimulation in the
      prevention of nephrotic syndrome relapses and treatment of proteinuria in pediatric patients
      with idiopathic nephrotic syndrome.

      Patients will be enrolled if they have frequently-relapsing idiopathic nephrotic syndrome or
      proteinuria which does not respond to steroid therapy. These patients will perform daily
      transcutaneous auricular Vagus Nerve stimulation (taVNS) therapy 5 minutes a day for a 6
      month period and will be monitored for urine/bloodwork or clinical signs of nephrotic
      syndrome relapse.
    

Intervention name(s): Transcutaneous Auricular Vagus Nerve (taVNS) stimulation
Intervention type(s): Device
Intervention description(s): Participants in this study will perform home transcutaneous auricular vagus nerve stimulation (taVNS) for 5 minutes a day for a 6-month period. The device that will be used is the commercially available Roscoe Medical TENS 7000 vagus nerve stimulator. The device will be attached to the Cymba Concha of the ear via an electrode ear clip. The intensity of the stimulation will be slowly increased and adjusted to individual tolerability for each treatment. TaVNS will be performed for 5 minutes daily for a period of 6 months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a prospective cohort pilot study not formally classified as a specific trial phase. The study will involve two Arms, with 15 participants in each Arm of the study. Arm 1 will recruit patients with steroid-sensitive frequently-relapsing idiopathic nephrotic syndrome. Arm 2 will recruit patients with steroid-resistant idiopathic nephrotic syndrome. All participants in both Arms of the study will perform daily transcutaneous auricular vagus nerve stimulation (taVNS) therapy for 5 minutes each day. The study period will be 6 months. The participants will be monitored for labwork and clinical evidence of nephrotic syndrome relapse, comparing the number of relapses and level or proteinuria in the 6 months before starting taVNS therapy to number of relapses and level of proteinuria in the 6 month study period.
Masking: None (Open Label)
Primary purpose: Device Feasibility