166
Participants
Start Date
September 19, 2024
Primary Completion Date
August 26, 2028
Study Completion Date
August 19, 2030
Vagus Nerve Stimulation (VNS)
The surgical intervention for the implantation of the VNS medical device is performed by a neurosurgeon under general anesthesia and lasts about an hour. Two incisions are made on the left: one incision to implant an electrode wrapped around the vagus nerve, the other incision to implant the stimulator. The electrode and the stimulator are connected by a cable tunneled. The cardiac tolerance is usually tested at the end of the surgery by turning on the neurostimulator for a few minutes. The stimulator is turned on about two weeks after the implantation, and after the neurosurgeon has checked the quality of healing. The settings used in first intention are standardized and derived from the parameters usually used for the treatment of epilepsies: a pulse width of 250μs, a stimulation frequency of 30Hz, and a 30sec stimulation cycle (ON) every 5min (OFF). Intensity is progressively increased by steps of 0.25mA to reach the 1.5-2mA range, depending on stimulation-induced side effects.
Best Medical Treatment
Best Medical Treatment for resistant depression.
NOT_YET_RECRUITING
Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception, Marseille
NOT_YET_RECRUITING
CHU Caen, Caen
RECRUITING
CHU Dijon, Hôpital Le Bocage, Dijon
RECRUITING
CHU Toulouse, Hôpital de Psychiatrie, Toulouse
RECRUITING
Centre Hospitalier Charles Perrens, Bordeaux
NOT_YET_RECRUITING
Centre Hospitalier Guillaume Regnier, Rennes
RECRUITING
CHRU Tours, Clinique Psychiatrique Universitaire, Tours
RECRUITING
CHU Grenoble Alpes, Grenoble
RECRUITING
CHU Saint-Etienne, Saint-Etienne
RECRUITING
CHU de Nantes, Hôtel Dieu, Nantes
ACTIVE_NOT_RECRUITING
CHU Angers, Angers
RECRUITING
CHU Lille, Lille
RECRUITING
CHU Clermont-Ferrand, Hôpital Gabriel Montpied, Clermont-Ferrand
NOT_YET_RECRUITING
Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Lyon
ACTIVE_NOT_RECRUITING
AP-HP. Sorbonne Université, Hôpital La Pitié Salpetrière, Paris
RECRUITING
GHU Paris Psychiatrie & Neuroscience, site Saint Anne, Paris
RECRUITING
CHU Rouen, Centre Hospitalier du Rouvray, Rouen
NOT_YET_RECRUITING
Centre Hospitalier Henri Laborit, Poitiers
WITHDRAWN
AP-HP. Nord - Université de Paris, Hôpital Louis Mourier, Colombes
NOT_YET_RECRUITING
APHP. Hôpitaux Universitaires Henri Mondor, Hôpital Henri Mondor, Créteil
WITHDRAWN
AP-HP. Université Paris Saclay, Hôpital Bicêtre, Le Kremlin-Bicêtre
WITHDRAWN
AP-HP. Centre - Université de Paris, Hôpital Corentin-Celton, Issy-les-Moulineaux
RECRUITING
CHU Nice, Hôpital Pasteur 1, Nice
Collaborators (1)
LivaNova
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER