A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
Key facts
- Who runs it
- Northwell Health
- Where
- New Hyde Park and Philadelphia, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 10 people, planned
- Started
- 19 Sept 2022
- Expected to end
- 1 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- trascutaneous auricular vagus nerve stimulation
- Sham device
- Record updated
- 17 April 2026
Who can take part
- Age
- 3 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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 comply with the study protocol, in the investigator's judgment
Who cannot take part
- Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators)
- 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
- History of cardiac disease (arrhythmias, structural/functional abnormalities)
- Chronic rash or skin breakdown of the left ear at the cymba concha
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 17 years old?
Where in United States
- Cohen Children's Medical CenterNew Hyde Park, United StatesContact: Suzanne Vento, RNTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Kevin Meyers, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Intervention GroupTreatment being tested
The intensity setting for pulse amplitude will be adjusted to the participant's tolerance (if a sensation is felt) to a maximum level of 3.
Treatment: trascutaneous auricular vagus nerve stimulation
- Sham GroupSham treatment, for comparison
The sham device will be altered internally so that electrical stimulation is not delivered, but the device will appear to function. Externally, the sham device will look identical to the taVNS device. The participant will be told to increase the intensity until tolerated if a sensation is felt, but will be asked to stop at a maximum level of 3.
Treatment: Sham device
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Steroid Resistant Nephrotic Syndrome in Children
- Fit questions
- Built from NCT05583942, who can take part
- Record updated
- 17 April 2026