120
Participants
Start Date
September 30, 2025
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
active stimulation then placebo stimulation
"The active VNS stimulation will be applied in the hollow of the left outer ear on the auricular branch of the vagus nerve (cymba conchae), a session of 1 hour of stimulation per week, at a weak intensity value (between 2 to 5 mA), depending on the tolerance of each patient.~A transcutaneous vagus nerve stimulator Tens Eco Plus SCHWA MEDICO™ France with the Garches Azabou-Bao vagal electrode (the G electrode) will be used in this Clinical Investigation.~VNS placebo stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at a different site: the left ear lobule according to previously published methods (Fang et al. 2017, Frangos et al. 2015).~The two stimulation periods will be separated by a 4 weeks wash-out period."
placebo stimulation then active stimulation
"VNS placebo stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at a different site: the left ear lobule according to previously published methods (Fang et al. 2017, Frangos et al. 2015).~The active VNS stimulation will be applied in the hollow of the left outer ear on the auricular branch of the vagus nerve (cymba conchae), a session of 1 hour of stimulation per week, at a weak intensity value (between 2 to 5 mA), depending on the tolerance of each patient.~A transcutaneous vagus nerve stimulator Tens Eco Plus SCHWA MEDICO™ France with the Garches Azabou-Bao vagal electrode (the G electrode) will be used in this Clinical Investigation.~The two stimulation periods will be separated by a 4 weeks wash-out period."
Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP, Garches
Assistance Publique - Hôpitaux de Paris
OTHER