Actively Recruiting
A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Steroid Resistant Nephrotic Syndrome in Children
Led by Northwell Health · Updated on 2026-04-17
10
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the use of transcutaneous auricular vagus nerve stimulation (taVNS) as a new treatment option for children aged 3 to 17 years with steroid resistant nephrotic syndrome (SRNS). Children with SRNS often face long-term use of immunosuppressant medications that can have side effects and uncertain benefits. The study focuses on the safety, feasibility, and potential effects of taVNS on immune-related inflammation in this condition. Participants will be randomly assigned to receive either active taVNS or a sham version of the device that looks identical but does not deliver electrical stimulation. Each child will use the device for 5 minutes daily over 26 weeks. The taVNS device sends gentle electrical pulses to the ear's vagus nerve branch. The study includes a screening period, a 26-week randomized treatment phase with monthly in-person and virtual visits, and a 26-week follow-up period to monitor clinical outcomes. After the randomized phase, participants can choose to continue active taVNS in an open-label extension. During the study, children will log heart rate and urine protein levels daily and attend regular visits for physical exams, blood and urine tests, and adherence checks. Researchers will assess kidney function, protein in urine, quality of life, inflammatory markers, and treatment tolerability. Safety and side effects will be monitored throughout. The overall participation lasts up to about 60 weeks, including screening, treatment, and follow-up periods.
CONDITIONS
Brief Title
A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 17 years
- Diagnosed with steroid resistant nephrotic syndrome (no remission after 4 weeks of standard steroid therapy)
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73 m2 or higher
- Diagnosis of minimal change disease or focal segmental glomerulosclerosis confirmed by biopsy
- Urine protein to creatinine ratio (UPC) greater than 1.0
- Stable immunosuppression and ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months
- Evidence of B cell recovery if previously treated with rituximab
- Informed consent from parent or guardian and assent from children aged 7 years or older
- Ability to follow the study protocol as judged by the investigator
You will not qualify if you...
- Secondary causes of nephrotic syndrome such as genetic, congenital, or infectious origins
- Steroid sensitive nephrotic syndrome
- Known genetic defects causing nephrotic syndrome (e.g., NPHS2, NPHS1, PLCE1, WT1)
- Any known inflammatory condition
- History of cardiac disease including arrhythmias or structural abnormalities
- Presence of implantable electronic devices such as pacemakers or cochlear implants
- Chronic rash or skin breakdown on the left ear where stimulation is applied
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 8 weeks
Participants are screened for eligibility to participate in the trial.
Informed consent and eligibility confirmation visits occur during this period prior to any study procedures.
Duration - 26 weeks
Participants use the taVNS or sham device daily for 5 minutes each day. They monitor heart rate with each treatment and log home urine results. Participants attend monthly visits alternating between in-person and virtual telehealth visits to assess health status, collect samples, and monitor adherence and adverse events.
In-person visits at Weeks 8, 16, and 26 alternating with virtual visits at Weeks 4, 12, and 20
Duration - 26 weeks
After completing the treatment period, participants are followed for an additional 26 weeks to assess clinical status, including nephrotic syndrome relapses and urine protein levels. Follow-up visits occur either in-person or via telehealth every 8 weeks, depending on participant preference and clinical schedule.
In-person or telehealth visits every 8 weeks
Trial Site Locations
Total: 2 locations
1
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Christine B Sethna, MD, EdM
S
Suzanne Vento, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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