A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Frequently Relapsing Nephrotic Syndrome in Children

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.

CT.gov Identifier
NCT05588063
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Northwell Health
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Focal Segmental Glomerulosclerosis
Study Drug
Sham device
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Transcutaneous auricular vagus nerve stimulation
Roscoe TENS 7000
Genes
N/A
Study Dates
Jan 2023 - Mar 2027
Sex
Ignored
Age
3 - 17 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • * 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)
  • * Steroid sensitive nephrotic syndrome (prior history of remission within 4 weeks of steroid therapy)
  • * In remission at time of enrollment (remission defined as UPC <0.2 or negative dipstick for 3 consecutive days)
  • * Informed consent from the parent or guardian and assent from a minor of ≥ 7. years
Exclusion Criteria:
  • 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
  • * Receiving any standing immunosuppression (previous exposure > 2 months allowed and/or B cell repletion)
  • * Any known inflammatory condition (e.g. systemic lupus erythematosis)
  • * History of cardiac disease (arrhythmias, structural/functional abnormalities)
  • * Implantable electronic devices
  • * Pregnancy
  • * Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Protocol Summary

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.

Study Locations

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