Recruiting

taVNS

Sponsor:

Northwell Health

Code:

NCT07791290

Conditions

Healthy Controls Group - Age and Sex-matched

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Vagustim Individual Device

Study Details

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

Study ID

NCT07791290

Start date

Jun 20, 2025

Status verified date

Aug, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 urinary tract infection (UTI), microscopic hematuria, etc. )
3. History of cardiac disease (arrhythmias, structural/functional abnormalities).
4. Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants, or deep brain stimulators).
5. Chronic rash or skin breakdown of the left ear at the cymba concha.
6. Pregnancy or breast feeding.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Christine Sethna, MD

718-470-3491csethna@northwell.edu

Suzanne Vento, RN

svento@northwell.edu

Locations

Cohen Children's Medical Center, Pediatric Nephrology

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

Christine Sethna, MD

718-470-3491csethna@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-08-27.