30
Participants
Start Date
July 31, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
active aVNT vs. Sham
Patients in both groups will receive daily stimulation with the Parasym device, temporarily connected to the tragus of the right ear (Fig 2).54 The stimulation parameters will be frequency of 20 Hz, pulse width of 200 µs, and the stimulation amplitude will be titrated to 1 mA below the discomfort threshold, consistent with parameters used in published clinical studies.54-56 With this stimulation at just below the discomfort threshold, people will often feel the stimulation for less than 60 seconds before they lose awareness of the ongoing stimulation. The stimulation will continue for 1 hour daily for 3 months, and we will track its use with a patient diary. Participants can continue their regular activities while wearing the aVNT device, as long as it is not soaked in water. Parasym will obtain Health Canada approval for use of their device in the study.
University of Calgary
OTHER