Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age greater than or equal to 18 years
Capable of giving informed consent or have an acceptable surrogate capable of giving consent on the participant's behalf.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Disqualifiers
Participants or guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Any known inflammatory condition (e.g., SLE) or other chronic condition including kidney disease (exceptions: temporary urinary conditions, including urinary tract infection (UTI), microscopic hematuria, etc. )
History of cardiac disease (arrhythmias, structural/functional abnormalities).
Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants, or deep brain stimulators).
Trial design
Design model
Parallel
Treatments tested in this trial
Vagustim Individual Device
DeviceThe 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
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Sham treatmentSham comparator 1 intervention
Group B: Active treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum TNF
Serum TNF will be measured as a response to treatment with taVNS while the sham group will maintain similar levels throughout the study period.
Time frame
T=0 and T=2 hours after treatmentSponsors and contacts
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Source ClinicalTrials.gov