taVNS for FRNS in Children
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
- 30 people, planned
- Started
- 5 Jan 2023
- Expected to end
- 1 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Transcutaneous auricular vagus nerve stimulation
- Sham device
- Record updated
- 15 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
- 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
Who cannot take part
- Exposure to steroids within 14 days of enrollment
- Receiving any standing immunosuppression (previous exposure > 2 months allowed and/or B cell repletion)
- Secondary forms of nephrotic syndrome
- Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids)
- Any known inflammatory condition (e.g. systemic lupus erythematosis)
- History of cardiac disease (arrhythmias, structural/functional abnormalities)
- SRNS
- Implantable electronic devices
- Pregnancy
- Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
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 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.
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 on the dial indicator. The remaining settings will be stored in the device and will not need to be set for each treatment. Participants and guardians will be instructed to adjust intensity to highest level of tolerance each time the device is used and level will be logged.
Treatment: Transcutaneous auricular vagus nerve stimulation
- Sham GroupSham treatment, for comparison
The sham device will be disabled 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. This inactive sham method was chosen because previous studies have shown that stimulation with placement of the ear clip on other parts of the ear such as the earlobe, although not innervated by the vagus nerve, results in some vagus nerve activity. Inactive sham methodology has been used in previous studies.
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 Frequently Relapsing Nephrotic Syndrome in Children
- Fit questions
- Built from NCT05588063, who can take part
- Record updated
- 15 April 2026