44
Participants
Start Date
April 15, 2024
Primary Completion Date
March 14, 2026
Study Completion Date
May 14, 2026
transcutaneous vagus nerve stimulation (tVNS)
tVNS allows the non-invasive stimulation of the Vagus Nerve by delivering electrical pulses to the sensory afferent fibers of the auricular, thick-myelinated, branch of the vagus nerve in the outer ear. TVNS seems to engage the same neural pathways of invasive VNS methods and may provide a novel, bottom-up NIBS method to enhance gamma-aminobutyric acid and Noradrenaline levels, which play a pivotal role in brain plasticity. The stimulation will be performed by using a Conformite Europeenne (CE) marked tVNS device tVNS®E (tVNS, technologies Gesellschaft mit beschränkter Haftung (GMBH), Erlangen, Germany). It consists in a programmable stimulation unit connected to two titan ear electrodes that are mounted on a gel frame, allowing to generate and transfer electric impulses from the stimulation unit to the surface of the skin, where the electrodes are applied.
Scientific Institute, IRCCS E. Medea, Bosisio Parini
"IRCCS National Neurological Institute C. Mondino Foundation"
OTHER
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
OTHER
IRCCS Eugenio Medea
OTHER