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Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices

Northwell Health · NCT07791290

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
June 20, 2025
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Vagustim Individual Device

Conditions: Healthy Controls Group - Age and Sex-matched

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Recruiting US locations

  • Cohen Children's Medical Center, Pediatric Nephrology

    New Hyde Park, NY 11042

    Site contact: Christine Sethna, MD · 718-470-3491 · csethna@northwell.edu

Study contacts (from the official record)

  • Christine Sethna, MD · 718-470-3491 · csethna@northwell.edu
  • Suzanne Vento, RN · svento@northwell.edu
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Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices (NCT07791290) | Bored Studies