About this trial
Children with frequently relapsing nephrotic syndrome (FRNS) are exposed to prolonged courses of steroids and other 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 non invasively 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.
Eligibility criteria
Qualifiers
FRNS
Age 3-17 years
Glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2
Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy)
Disqualifiers
Secondary forms of nephrotic syndrome
SRNS
Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids)
Exposure to steroids within 14 days of enrollment
Trial design
Treatments tested in this trial
- Transcutaneous auricular vagus nerve stimulation
- Sham device
Treatment groups
Sponsors and collaborators
Northwell Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator