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Device
Transcutaneous Auricular Vagus Nerve (taVNS) stimulation for Idiopathic Nephrotic Syndrome (taVNS Trial)
N/A
Waitlist Available
Led By Christine Sethna, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
taVNS Trial Summary
This trial will study whether electrical stimulation of the ear can help prevent nephrotic syndrome relapses in children.
Eligible Conditions
- Idiopathic Nephrotic Syndrome
- Nephrotic Syndrome
taVNS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of taVNS (Arms 1 and 2)
Secondary outcome measures
Cytokine
Impact of taVNS on level of proteinuria (Arm 2)
Impact of taVNS on number of nephrotic syndrome relapses, time to nephrotic syndrome relapses, and time to remission (Arm 1)
taVNS Trial Design
2Treatment groups
Experimental Treatment
Group I: Steroid Sensitive Frequently-Relapsing Nephrotic SyndromeExperimental Treatment1 Intervention
Individuals in this arm of the study will have to have a diagnosis of steroid sensitive frequently relapsing idiopathic nephrotic syndrome. They will receive transcutaneous auricular VNS (taVNS) performed for 5minutes every day for 6 months. The settings of the taVNS device will be individualized for each patient. Data will be collected on the the number of nephrotic syndrome relapses, the time between relapses, the time to remission once relapsed, and the level of proteinuria before and while using taVNS therapy.
Group II: Steroid Resistant Idiopathic Nephrotic SyndromeExperimental Treatment1 Intervention
Individuals in this arm of the study will have to have a diagnosis of steroid resistant idiopathic nephrotic syndrome. They will receive transcutaneous auricular VNS (taVNS) performed for 5minutes every day for 6 months. The settings of the taVNS device will be individualized for each patient. Data will be collected on the the number of nephrotic syndrome relapses, the time between relapses, the time to remission once relapsed, and level of proteinuria before and while using taVNS therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Auricular Vagus Nerve (taVNS) stimulation
2019
N/A
~10
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
460 Previous Clinical Trials
471,036 Total Patients Enrolled
Christine Sethna, MDPrincipal InvestigatorNorthwell Health
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