Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices

NCT07791290 | Recruiting FDA Device

• 1 other identifier: NW IRB #25-0263
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Controls Group - Age and Sex-matched

Outcome Measures

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.

  T=0 and T=2 hours after treatment

Study Arms (2)

Sham treatment

SHAM COMPARATOR

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.

Device: Vagustim Individual Device

Active treatment

ACTIVE COMPARATOR

Those who are randomized to the active treatment will receive vagus nerve stimulation for the full 10 minutes of their session.

Device: Vagustim Individual Device

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

Active treatment; Sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Chronic rash or skin breakdown of the left ear at the cymba concha.
• Pregnancy or breast feeding.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Cohen Children's Medical Center, Pediatric Nephrology

New Hyde Park, New York, 11042, United States

RECRUITING

Central Study Contacts

Christine Sethna, MD

CONTACT

718-470-3491; csethna@northwell.edu

Suzanne Vento, RN

CONTACT

svento@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: August 27, 2026
• Study Start: June 20, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)