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taVNS for Nephrotic Syndrome in Children (kidNEY-VNS Trial)

Q: Does this experiment accept elderly participants?

This clinical trial is seeking participants aged 3 to 17. Additionally, there are 384 trials recruiting for individuals under 18 and 1003 specifically catering to elderly patients over 65.

Q: How many participants are being enrolled in this clinical research program?

Affirmative. Clinicaltrials.gov has this medical trial listed as open for recruitment, which was first posted on October 1st 2022 and recently modified on the 13th of October 2022. 30 subjects are needed from two different centres to complete the study successfully.

Q: Is there room for more participants within this research endeavor?

As per information provided at clinicaltrials.gov, this trial is presently recruiting patients and began with a post date of October 1st 2022 before being edited on the 13th of that month.

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

Age 3-17 years

Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 26 weeks

Awards & highlights

kidNEY-VNS Trial Summary

This trial is studying a new, non-invasive way to treat nephrotic syndrome in children with fewer side effects than current treatments.

Who is the study for?

This trial is for children aged 3-17 with frequently relapsing nephrotic syndrome, specifically those diagnosed with Minimal Change Disease or Focal Segmental Glomerulosclerosis. They must be in remission and have responded to steroids before. Kids can't join if they've taken steroids recently, are on other immunosuppressants, have electronic implants, are pregnant, or have certain heart diseases or inflammatory conditions.Check my eligibility

What is being tested?

The study tests transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive treatment that might regulate the immune system without drugs' side effects. Children will be randomly assigned to either real taVNS therapy or a sham device to compare effectiveness and impact on inflammation markers.See study design

What are the potential side effects?

While specific side effects of taVNS aren't detailed here, similar non-invasive nerve stimulation treatments may cause mild skin irritation at the site of application, headache, dizziness or changes in heart rate.

kidNEY-VNS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 17 years old.

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I have been diagnosed with MCD or FSGS.

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My kidney function, measured by eGFR, is at least 30.

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My kidney condition is currently in remission.

kidNEY-VNS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 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 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.

Group II: Sham GroupPlacebo Group1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,903 Total Patients Enrolled

3 Trials studying Nephrotic Syndrome

21 Patients Enrolled for Nephrotic Syndrome

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,044 Total Patients Enrolled

14 Trials studying Nephrotic Syndrome

6,398 Patients Enrolled for Nephrotic Syndrome

Media Library

Transcutaneous auricular vagus nerve stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05588063 — N/A

Nephrotic Syndrome Research Study Groups: Sham Group, Intervention Group

Nephrotic Syndrome Clinical Trial 2023: Transcutaneous auricular vagus nerve stimulation Highlights & Side Effects. Trial Name: NCT05588063 — N/A

Transcutaneous auricular vagus nerve stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05588063 — N/A

Frequently Asked Questions

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

Who can be admitted into this research program?

"The trial seeks 30 minors (aged 3-17) with nephrotic syndrome. Eligibility requirements include: FRNS, eGFR ≥30 ml/min/1.73 m2, MCD or FSGS diagnosis, steroid sensitivity, remission at enrollment (UPC <0.2 or negative dipstick for 3 days), parental consent and child assent of 7 years+."

Answered by AI

Does this experiment accept elderly participants?

"This clinical trial is seeking participants aged 3 to 17. Additionally, there are 384 trials recruiting for individuals under 18 and 1003 specifically catering to elderly patients over 65."

Answered by AI

How many participants are being enrolled in this clinical research program?

"Affirmative. Clinicaltrials.gov has this medical trial listed as open for recruitment, which was first posted on October 1st 2022 and recently modified on the 13th of October 2022. 30 subjects are needed from two different centres to complete the study successfully."

Answered by AI

Is there room for more participants within this research endeavor?

"As per information provided at clinicaltrials.gov, this trial is presently recruiting patients and began with a post date of October 1st 2022 before being edited on the 13th of that month."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

taVNS for FRNS in Children

2022. "taVNS for FRNS in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05588063.

All > Nephrotic Syndrome