Recruiting

taVNS

Sponsor:

Northwell Health

Code:

NCT05583942

Conditions

Nephrotic Syndrome in Children

Minimal Change Disease

Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

trascutaneous auricular vagus nerve stimulation

Sham device

Study Details

Brief 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.

Conditions

Nephrotic Syndrome in Children

Minimal Change Disease

Focal Segmental Glomerulosclerosis

Study ID

NCT05583942

Start date

Sep 19, 2022

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:

  • 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

Exclusion Criteria:

  • 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)
  • Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators)
  • Chronic rash or skin breakdown of the left ear at the cymba concha
  • Pregnancy

Study Design

Enrollment

10 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.

sham comparator: Sham Group

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.

Interventions

trascutaneous 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 to 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 B Sethna, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kevin Meyers, MD

215-590-2449meyersk@chop.edu

Principal Investigator:

Kevin Meyers, MD

More Information

Sponsor

Northwell Health

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • vagus nerve stimulation
  • pediatric
  • nephrology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-04-17.