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Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices
Sponsor: Northwell Health
Summary
Transcutaneous auricular vagus nerve stimulation (taVNS) has become a therapy of interest for treating chronic immune-medicated illnesses in adults and children. Vagustim™ taVNS devices are commercially available devices that have been used in clinical and non-clinical studies examining inflammatory conditions. Previous work of the investigative team has utilized TENS devices from Roscoe Medical to deliver stimulation. We aim to evaluate Vagustim™'s sham stimulation method as a placebo for clinical trials.
Official title: A Pilot Feasibility Study of Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-06-20
Completion Date
2027-12-30
Last Updated
2026-10-09
Healthy Volunteers
Yes
Interventions
Vagustim Individual Device
The Vagustim™ Individual Device is a 134mm x 70mm x 25 mm device that provides targeted vagus nerve stimulation via an in-ear or clip-on electrode. Please see below for exact pulse stimulation parameters and programming: * Waveform: Symmetrical biphasic rectangular waveform. * Frequency Range: Adjustable from 1 Hz to 100 Hz. * Pulse Width: Configurable between 50 µs and 1000 µs. * Intensity: Adjustable up to 10 mA with fine-tuned increments for patient-specific needs. * Stimulation Modes: Bilateral (both ears) or unilateral (one ear) stimulation. * Power Supply: Operates on 2xAA batteries for portability and reliability. * Connectivity: Bluetooth Low Energy 4.2 for seamless app integration. * Construction: Durable materials suitable for repeated professional use in clinical environments. * Duration of implant or exposure: 10 minutes * Frequency of exposure: Once during study visit
Locations (1)
Cohen Children's Medical Center, Pediatric Nephrology
New Hyde Park, New York, United States