Effect of Daily Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Proteinuria in Pediat… (NCT04169776) | Clinical Trial Compass
CompletedNot Applicable
Effect of Daily Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Proteinuria in Pediatric Patients With Idiopathic Nephrotic Syndrome
United States7 participantsStarted 2019-12-01
Plain-language summary
This study evaluates the impact of transcutaneous auricular Vagus Nerve stimulation (taVNS) therapy on the incidence of nephrotic syndrome relapses in children with idiopathic nephrotic syndrome. Participants will perform taVNS 5 minutes a day for 6 months total, monitoring for signs of nephrotic syndrome relapse with both labwork and clinical symptoms.
Who can participate
Age range2 Years – 21 Years
SexALL
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Inclusion criteria
✓. Subjects age 2-21 years of age
✓. eGFR \> 60 ml/min/1.73 m2
✓. Diagnosis of idiopathic minimal change disease (clinical diagnosis or per biopsy)
✓. Prior history of remission of nephrotic syndrome within 4 weeks of initiation of steroid therapy (steroid sensitive nephrotic syndrome)
✓. 2 or more episodes of nephrotic syndrome relapses in a 6-month period or four or more episodes of nephrotic syndrome relapses in a 12-month period (relapse defined as 2+ proteinuria on first morning urine sample for three consecutive days or development of edema)
✓. In remission (no proteinuria - normal urine protein to creatinine ratio \< 0.2) at the time of enrollment
✓. Subjects age 2-21 years of age
✓. eGFR \> 60 ml/min/1.73 m2
Exclusion criteria
✕. Subjects with nephrotic syndrome etiology other than idiopathic minimal change disease either biopsy-proven or by genetic testing
✕. Nephrotic syndrome due to secondary causes such as SLE, vasculitis, hepatitis, post-infectious etiology, medication-induced, etc.
✕. Subjects that did not achieve remission of nephrotic syndrome within 4 weeks of initiation of steroid therapy (steroid-resistant nephrotic syndrome)
. Subjects with urine protein to creatinine ratio of \> 0.2 (not in remission)
✕. Subjects currently receiving any standing immunosuppressive therapy (mycophenolate mofetil, tacrolimus, rituximab - note: 1) previous exposure to these therapies does not exclude participation; 2) subjects with previous exposure to rituximab are eligible if B cells are replete)
✕. Subjects with a history of cardiac issues, including bradycardia, arrhythmias or structural abnormalities of the heart
✕. Subjects with implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators
✕. Subjects with any other known inflammatory condition (IBD, SLE, etc.)