Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT07791290
Status
Recruiting
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Conditions

  • Healthy Controls Group - Age and Sex-matched

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vagustim Individual Device — 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

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Jun 20, 2025
Status verified
Aug 2026
Primary completion
Aug 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham treatment
    Those who are randomized to the sham treatment will receive vagus nerve stimulation for 10 seconds at the beginning of the 10 minute treatment session.
  • Active Comparator: Active treatment
    Those who are randomized to the active treatment will receive vagus nerve stimulation for the full 10 minutes of their session.

Primary Outcome Measure

Serum TNF [ Time Frame: T=0 and T=2 hours after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cohen Children's Medical Center, Pediatric NephrologyNew Hyde ParkNew York11042
Christine Sethna, MD
[email protected]
718-470-3491

Find similar trials in New Hyde Park, NY

By research site
Cohen Children's Medical Center, Pediatric Nephrology· New Hyde Park, NY

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