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Device

Vagus Nerve Stimulation for Nephrotic Syndrome (kidNEY-VNS Trial)

N/A
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of B cell repletion for those exposed to rituximab
Age 3-17 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 26 weeks
Awards & highlights

kidNEY-VNS Trial Summary

This trial will look at using noninvasive stimulation of the vagus nerve to treat nephrotic syndrome in children. It will assess safety, tolerability, and effectiveness of the therapy.

Who is the study for?
This trial is for children aged 3-17 with steroid-resistant nephrotic syndrome, specifically those diagnosed with MCD or FSGS via biopsy. Participants must have stable medication regimens and no history of cardiac disease, skin issues at the stimulation site, secondary causes of nephrotic syndrome like genetic conditions, or any implantable electronic devices.Check my eligibility
What is being tested?
The study tests transcutaneous auricular vagus nerve stimulation (taVNS) against a sham device to see if it's a feasible and tolerable treatment for children's nephrotic syndrome. It also aims to understand taVNS's effects on inflammatory markers in these patients.See study design
What are the potential side effects?
Potential side effects are not detailed but may include discomfort at the stimulation site on the ear. Since taVNS is noninvasive and does not involve drugs, it may have fewer side effects compared to immunosuppressant medications.

kidNEY-VNS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My B cells have returned to normal after rituximab treatment.
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I am between 3 and 17 years old.
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My immunosuppression and blood pressure medication have been stable for 3 months.
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My kidney biopsy shows I have MCD or FSGS.
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My kidney condition did not improve after 4 weeks of standard steroid treatment.

kidNEY-VNS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Success of Pilot Trial
Secondary outcome measures
Adverse events
Anti-nephrin antibodies
Cytokine
+11 more

kidNEY-VNS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention GroupExperimental Treatment1 Intervention
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.
Group II: Sham GroupPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
457 Previous Clinical Trials
470,249 Total Patients Enrolled
3 Trials studying Nephrotic Syndrome
41 Patients Enrolled for Nephrotic Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,398 Total Patients Enrolled
14 Trials studying Nephrotic Syndrome
6,418 Patients Enrolled for Nephrotic Syndrome

Media Library

taVNS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05583942 — N/A
Nephrotic Syndrome Research Study Groups: Intervention Group, Sham Group
Nephrotic Syndrome Clinical Trial 2023: taVNS Highlights & Side Effects. Trial Name: NCT05583942 — N/A
taVNS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583942 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still able to join this experiment?

"As per the information hosted on clinicaltrials.gov, this research is currently seeking participants. The trial was initially posted to the website October 1st 2022 and has been updated most recently on October 13th of that same year."

Answered by AI

Is the target demographic for this experiment restricted to those aged 50 or above?

"In order to take part in this research, participants must be aged between 3 and 17. 384 trials are available for minors, whilst 1003 studies welcome those over 65 years old."

Answered by AI

What criteria must a person meet in order to be eligible for this research initiative?

"This trial seeks to recruit 10 children between the ages of 3 and 17 suffering from nephrotic syndrome. All prospective participants must meet various criteria, including but not limited to: Steroid Resistant Nephrotic Syndrome- as defined by lack of remission after a month on prednisolone/prednisone, eGFR ≥30 ml/min/1.73 m2 (as calculated using modified Schwartz formula), UPC greater than 1.0, B cell repletion in individuals who have been exposed to rituximab therapy, consent from parent or guardian for minors aged 7 and above and ability to comply"

Answered by AI

How many individuals are being given treatment as part of this clinical research?

"Affirmative. Data on clinicaltrials.gov indicates that this medical experiment, first posted October 1st 2022, is actively seeking participants. There are 2 sites participating in the recruitment of 10 individuals for the trial."

Answered by AI
~5 spots leftby Jul 2025