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

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.

Primary Outcome

1. Unsuccessful: main study not practicable 1. None of the primary feasibility and tolerability benchmarks are met, or 2. One or more of the primary benchmarks are not met and there is low likelihood of reaching benchmarks even with protocol modifications or 3. Serious adverse events related to the treatment. 2. Probable Success: main study practicable with modifications to protocol. One or more of the primary benchmarks are not met, but there is a high likelihood that the benchmark ca

Conditions Studied

Interventions

• DEVICE Sham device
• DEVICE trascutaneous auricular vagus nerve stimulation

Study Locations (2)