A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Steroid Resistant Nephrotic Syndrome in Children
Northwell Health
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.
Description
A parallel, double blinded, randomized placebo controlled trial comparing daily taVNS use with sham therapy will be conducted in children 3 to 17 years of age with SRNS. Ten participants with SRNS, defined as lack of response to steroids after 4 weeks, 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 or inactive for sham arm) for 5 minutes each day for a total of 26 weeks. Participa…
Eligibility
- Age range
- 3–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone/prednisone at standard dose1 * Age 3-17 years * eGFR ≥30 ml/min/1.73 m2 (by modified Schwartz formula) * MCD or FSGS diagnosis (per biopsy) * Urine protein:creatinine (UPC) greater than 1.0 * Stable immunosuppression and ACE inhibitor/angiotensin receptor blocker treatment regimen for at least three months * Evidence of B cell repletion for those exposed to rituximab * Informed consent from the parent or guardian and assent from a minor of ≥ 7 years * Ability to co…
Interventions
- Devicetrascutaneous 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