A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Frequently Relapsing Nephrotic Syndrome in Children
Northwell Health
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.
Description
Study Design A parallel, double blinded, randomized placebo controlled trial comparing daily taVNS use with sham therapy will be conducted in children 3 to17 years of age with FRNS. Thirty participants with FRNS (defined as having 2 or more relapses in 6 months within 6 months of diagnosis or 4 or more relapses in any 12 month period) will be randomized 1 to 1 to taVNS or sham therapy. Participants will be enrolled at two pediatric tertiary hospitals over a two year time period, with completion of the study by year three. All participants will perform daily taVNS therapy (active for taVNS arm…
Eligibility
- Age range
- 3–17 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceTranscutaneous auricular vagus nerve stimulation
The device to be used is the Roscoe Medical TENS 7000, a commercially available handheld electrical pulse generator, and an ear clip to be placed at the left ear for stimulation. Custom-made ear clips with electrode gel will be placed near the entrance to the canal of the ear to provide stimulation to the auricular branch. The handheld electrical pulse generator will be programmed to deliver electrical stimulation pulses to the cymba concha stimulating the auricular branch of the vagus nerve.
- DeviceSham device
The device will appear to function but no electrical stimulation will be delivered.
Locations (2)
- Cohen Children's Medical CenterNew Hyde Park, New York
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania