Study Summary
Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated noninvasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.
- Nephrotic Syndrome
- Focal Segmental Glomerulosclerosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 14 Secondary · Reporting Duration: Baseline to 26 weeks
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Intervention Group
1 of 2
Sham Group
1 of 2
Experimental Treatment
Non-Treatment Group
10 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention Group · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 3 - 17 · All Participants · 9 Total Inclusion Criteria
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