A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)

NCT05583942 | Recruiting DMC FDA Device

• 2 other identifiers: 22-0488-A1R01DK131091-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Keywords

vagus nerve stimulation; pediatric; nephrology

Outcome Measures

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.

  Baseline to 26 weeks

Secondary Outcomes (14)

• Effect size for change in Change in quality of life (PedsQL)

  Baseline to 26 weeks

• Effect size for change in urine protein:creatinine

  Baseline to 26 weeks

• Effect size for change in lipid profile

  Baseline to 26 weeks

• Effect size for change in proportion with at least a 30 percent reduction in UPC

  Baseline to 26 weeks

• Recruitment rate

  Baseline to 26 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Device: trascutaneous auricular vagus nerve stimulation

Sham Group

SHAM COMPARATOR

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.

Device: Sham device

Interventions

trascutaneous auricular vagus nerve stimulation DEVICE

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.

Also known as: Roscoe TENS 7000

Intervention Group

Sham device DEVICE

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

Also known as: Roscoe TENS 7000

Sham Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Nephrosis, Lipoid; Glomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis

Central Study Contacts

Christine B Sethna, MD, EdM

CONTACT

718-470-3491; csethna@northwell.edu

Suzanne Vento, RN

CONTACT

718-470-3491; svento@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial will be double-blinded to the investigators and participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blind sham controlled clinical trial

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 18, 2022
• Study Start: September 19, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 12 months of study closure.
• Access Criteria: Consent forms will be uploaded to clinical trials.gov. Data is available from the PI upon request.

Locations

US (2)