taVNS for FRNS in Children

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT05588063
Status
Recruiting
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Conditions

  • Focal Segmental Glomerulosclerosis
  • Minimal Change Disease
  • Nephrotic Syndrome in Children

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous 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.
  • Sham device — DEVICE
    The device will appear to function but no electrical stimulation will be delivered.

Study Details

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.

Key Dates

Start date
Jan 5, 2023
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cohen Children's Medical CenterNew Hyde ParkNew York11040
Suzanne Vento, RN
[email protected]
718-470-3491
Christine Sethna, MD, EdM (PRINCIPAL_INVESTIGATOR)
Kevin Tracey, MD (SUB_INVESTIGATOR)
Sangeeta Chavan, PhD (SUB_INVESTIGATOR)
Timir Datta-Chaudhuri, PhD (SUB_INVESTIGATOR)
Stavros Zanos, MD, PhD (SUB_INVESTIGATOR)
Cliff Deutschman, MD, PhD (SUB_INVESTIGATOR)
Joanna FIshbein, MS (SUB_INVESTIGATOR)
Martin Lesser, PhD (SUB_INVESTIGATOR)
Matthew Taylor, MD (SUB_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19102
Kevin Meyers, MD
[email protected]
215-590-2449
Kevin Meyers, MD (SUB_INVESTIGATOR)

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By research site
Cohen Children's Medical Center· New Hyde Park, NYChildren's Hospital of Philadelphia· Philadelphia, PA

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