NCT07791290 Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices
| NCT ID | NCT07791290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Healthy Controls Group - Age and Sex-matched |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-06-20 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07791290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Controls Group - Age and Sex-matched. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07791290 currently recruiting?
Yes, NCT07791290 is actively recruiting participants. Contact the research team at csethna@northwell.edu for enrollment information.
Where is the NCT07791290 trial being conducted?
This trial is being conducted at New Hyde Park, United States.
Who is sponsoring the NCT07791290 clinical trial?
NCT07791290 is sponsored by Northwell Health. The trial plans to enroll 20 participants.