Recruiting

taVNS

Sponsor:

Northwell Health

Code:

NCT05588063

Conditions

Nephrotic Syndrome in Children

Minimal Change Disease

Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Transcutaneous auricular vagus nerve stimulation

Sham device

Study Details

Brief 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.

Conditions

Nephrotic Syndrome in Children

Minimal Change Disease

Focal Segmental Glomerulosclerosis

Study ID

NCT05588063

Start date

Jan 5, 2023

Status verified date

Apr, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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 dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids)
  • Exposure to steroids within 14 days of enrollment
  • Receiving any standing immunosuppression (previous exposure > 2 months allowed and/or B cell repletion)
  • Any known inflammatory condition (e.g. systemic lupus erythematosis)
  • History of cardiac disease (arrhythmias, structural/functional abnormalities)
  • Implantable electronic devices
  • Pregnancy
  • Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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.

sham comparator: Sham Group

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.

Interventions

Transcutaneous 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.

Sham device

The device will appear to function but no electrical stimulation will be delivered.

Primary outcome measure

  • Success of Pilot Trial [ Time Frame: Baseline through 26 weeks ]

Central Contacts and Locations

Central contacts

Christine B Sethna, MD, EdM

718-470-3491csethna@northwell.edu

Suzanne Vento, RN

718-470-3491svento@northwell.edu

Locations

Cohen Children's Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Suzanne Vento, RN

718-470-3491svento@northwell.edu

Principal Investigator:

Christine Sethna, MD, EdM

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19102

Contacts

Kevin Meyers, MD

215-590-2449meyersk@chop.edu

More Information

Sponsor

Northwell Health

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • vagus nerve stimulation
  • pediatric
  • nephrology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-04-15.