44
Participants
Start Date
January 27, 2025
Primary Completion Date
April 30, 2026
Study Completion Date
August 30, 2026
Active Transcutaneous Auricular Vagus Nerve Stimulation
Stimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the tVNS R device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA). Pulse width will be set at 100μs and frequency will be set at 25Hz. Parameters will be set for the duration of the intervention consisting of 4 hours of daily stimulation for a period of 30 days.
Sham Transcutaneous Auricular Vagus Nerve Stimulation
Stimulation will target the ear lobe using the NEMOS® taVNS device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA). Pulse width will be set at 100μs and frequency will be set at 25Hz. Participants will perform 4 hours of stimulation per day for a period of 30 days. Stimulation will be applied to the ear lobe in order to ensure participant feel the stimulation while avoiding activation of the vagus nerve.
RECRUITING
Parkwood Institute, St Joseph's Health Care London, London
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER