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Recruiting
NCT07791290
Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices
Conditions: Healthy Controls Group - Age and Sex-matched
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 20
Sponsor: Northwell Health
Location: Cohen Children's Medical Center, Pediatric Nephrology New Hyde Park New York
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.
Source: ClinicalTrials.gov (NCT07791290). StuddyBuddy aggregates publicly available trial information.