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Optimization of the Parameters of Vagal Nerve Stimulation
Sponsor: Assistance Publique Hopitaux De Marseille
Summary
Vagal nerve stimulation (VNS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated. However to date it is not possible to predict which patients will respond and what are the best parameters of stimulation to be set (pulse width, frequency and intensity). It has been shown that responders to VNS have reduced interictal cortical synchronicity on scalp EEG based on phase lag index (PLI), a marker of functional connectivity (Fc) The aim of this study is to test the following hypothesis: setting the parameters of stimulation on the basis of the lowest values of Phase Lag Index (PLI) obtained on scalp EEG with different settings of parameters (as compared with a randomly chosen set of commonly used parameters) will increase the rate of responders to VNS.
Official title: Optimization of the Parameters of Vagal Nerve Stimulation in Pharmaco- Resistant Epileptic Patients Based on a Surface EEG Index of Functional Connectivity (PLI: Phase Lag Index): a Randomized Double-blind Multicenter Controlled Study.
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2021-04-16
Completion Date
2026-12-12
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Choice of VNS set of parameters based on the lowest PLI
Vagal nerve stimulation according to PLI results.
EEG
Patient will have an EEG and 12 sets of parameters will be tested. EEG results will be analyzed which will allow to determine the set involving the lowest phase lag index.
Locations (18)
Department of functional explorations of the nervous system, CHU
Amiens, France, France
Neuropediatrics department, CHU Angers
Angers, France, France
Neurology Department, CHU Bordeaux
Bordeaux, France, France
Clinical neurophysiology, CHU Dijon
Dijon, France, France
Epilepsy neurophysiopathology department, CHU Grenoble
Grenoble, France, France
Clinical neurophysiology, CHU Lille
Lille, France, France
HCL Lyon
Lyon, France, France
Department of clinical neurophysiology, Hôpital La Timone, APHM
Marseille, France, France
Neurosurgery Department, CHRU Nancy
Nancy, France, France
Neurosurgery Department, CHU Nantes
Nantes, France, France
Neurosurgery Department, APHP
Paris, France, France
Neurophysiology Department
Paris, France, France
Epileptology Department, CHU Rennes
Rennes, France, France
Neurophysiology Department, CHU Rouen
Rouen, France, France
Neurology Department, CHU Strasbourg
Strasbourg, France, France
Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan
Toulouse, France, France
Neurology and clinical neurophysiology, CHU Bretonneau
Tours, France, France
Hôpital St Joseph St Luc
Lyon, FRA, France