24
Participants
Start Date
May 1, 2024
Primary Completion Date
May 1, 2025
Study Completion Date
May 1, 2027
Active tVNS
"As for the short-term phase, the ear clip of the Parasym device (Parasym, London, United Kingdom), containing the stimulation electrode, will be positioned at the level of the patient's tragus, and a 10-minute stimulation will be initiated with a pulse width of 200 μs, a frequency of 30 Hz, and an intensity of one mA lower than the patient's sensitivity threshold.~As fort he mid-term phase, a device will be given to the patient, which will be instructed to position the ear clip of the device at the level of the tragus and to set stimulation parameters as established in the laboratory (see above). Each patient will be asked to undergo at least one hour daily stimulation for a period of 4 weeks, reporting on a diary the timing and details of the each session."
Sham tVNS
"As for the short-term phase, the ear clip of the Parasym device (Parasym, London, United Kingdom), containing the stimulation electrode, will be positioned at the level of the patient's tragus for 10-minute but no current will be delivered.~As fort he mid-term phase, a device (configured to withhold power delivery) will be given to the patient, which will be instructed to position the ear clip of the device at the level of the tragus and to set stimulation parameters as established in the laboratory (see above). Each patient will be asked to undergo at least one hour daily stimulation for a period of 4 weeks, reporting on a diary the timing and details of the each session."
Michele Emdin, Pisa
A.O.U. Città della Salute e della Scienza
OTHER
Fondazione Toscana Gabriele Monasterio
OTHER