A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorNorthwell Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious)
Steroid sensitive nephrotic syndrome
History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 [podocin], NPHS1 [nephrin], PLCE1, WT1, or other known genetic cause)
Any known inflammatory condition
Trial design
Design model
Parallel
Treatments tested in this trial
trascutaneous auricular vagus nerve stimulation
DeviceThe 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.
Sham device
DeviceThe device will appear to function but no electrical stimulation will be delivered.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Sham GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Success of Pilot Trial
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 can be met with protocol modifications. 3. Successful: main study practicable without modifications. All of the primary benchmarks are met.
Time frame
Baseline to 26 weeksSecondary outcomes
1
Effect size for change in Change in quality of life (PedsQL)
To calculate effect sizes for continuous main trial efficacy outcomes using a t test, Cohen's d test will be used.
Time frame
Baseline to 26 weeks2
Effect size for change in urine protein:creatinine
To calculate effect sizes for continuous main trial efficacy outcomes using a t test, Cohen's d test will be used.
Time frame
Baseline to 26 weeks3
Effect size for change in lipid profile
To calculate effect sizes for continuous main trial efficacy outcomes using a t test, Cohen's d test will be used.
Time frame
Baseline to 26 weeks4
Effect size for change in proportion with at least a 30 percent reduction in UPC
To estimate effect sizes for dichotomous main trial efficacy outcomes using Fisher's exact test, odds ratios will be calculated outcomes using a t test, Cohen's d test will be used.
Time frame
Baseline to 26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwell Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov