Home › NCT07791290

Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices

A Pilot Feasibility Study of Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

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.

About the study

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.

What is being tested

• Vagustim Individual Device (device)

Sponsor: Northwell Health · Participants: 20 · Started: Jun 20, 2025

Contact the study team

• Christine Sethna, MD · Phone: 718-470-3491

Official record on ClinicalTrials.gov — NCT07791290

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.