Northwell Health
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.
This study will be a double-blind, sham-controlled trial with 20 participants evaluating Vagustim™'s sham method as a placebo. Participants will be randomized to the active treatment group or the sham treatment group and undergo a one-time 10-minute taVNS treatment. Blood samples will be obtained immediately prior to treatment and two hours post-treatment to evaluate circulating cytokine levels. Participants will have blood samples obtained immediately prior to taVNS and two hours post-treatment. A one-time taVNS treatment will be performed with the assistance of an unblinded research coordina…
Inclusion Criteria: 1. Age greater than or equal to 18 years 2. Capable of giving informed consent or have an acceptable surrogate capable of giving consent on the participant's behalf. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: 1. Participants or guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 2. Any known inflammatory condition (e.g., SLE) or other chronic condition including kidney disease (exceptions: temporary urinary conditions, including urina…
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
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