40
Participants
Start Date
July 1, 2025
Primary Completion Date
June 1, 2026
Study Completion Date
September 1, 2026
Transauricular Vagal Nerve Stimulation
Transauricular VNS will be administered using the Parasym aVNT (auricular vagal neuromodulation therapy) Device (Nurosym, London, UK). The Parasym aVNT Device delivers non-invasive neuromodulation targeting the auricular branch of the vagus nerve via the tragus of the outer ear. All participants will receive four weeks of twice daily (morning and evening) 45-minute sessions of taVNS (frequency ≥ 25Hz; pulse width =250µs (Fig). The safety and tolerability of taVNS has been demonstrated in seven studies with a total of 205 (116 active, 121 sham) cardiovascular patients. Stimulation protocols ranged from 43 min to 8 hrs daily, for 1 day to 6 months. There were no device-related serious adverse events. Three patients (1.5%) experienced minor adverse events, i.e., dermal paresthesias (light tingling at the ear). No differences in tolerability were observed between active and sham taVNS \[21\].
Vivo Cura Health, Calgary
Vivo Cura Health
OTHER
University of Calgary
OTHER