Informations générales (source: ClinicalTrials.gov)
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. (OPSTIMVAG)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
avril 2021
décembre 2026
08 novembre 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Clinical neurophysiology, CHU Dijon - 21079 - Dijon - France | Martine Lemesle | Contact (sur clinicalTrials) | |||
| Clinical neurophysiology, CHU Lille - 59037 - Lille - France | Philippe Derambure | Contact (sur clinicalTrials) | |||
| Department of clinical neurophysiology, Hôpital La Timone, APHM - 13885 - Marseille - France | Romain Carron | Contact (sur clinicalTrials) | |||
| Department of functional explorations of the nervous system, CHU - 80054 - Amiens - France | William Szurhaj | Contact (sur clinicalTrials) | |||
| Epilepsy neurophysiopathology department, CHU Grenoble - 38043 - Grenoble - France | Philippe Kahane | Contact (sur clinicalTrials) | |||
| Epileptology Department, CHU Rennes - 35000 - Rennes - France | Arnaud Biraben | Contact (sur clinicalTrials) | |||
| HCL Lyon - 69003 - Lyon - France | Sylvain Rheims | Contact (sur clinicalTrials) | |||
| Hôpital St Joseph St Luc - 69007 - Lyon - FRA - France | Adrien Didelot | Contact (sur clinicalTrials) | |||
| Neurology and clinical neurophysiology, CHU Bretonneau - 37044 - Tours - France | Julien Biberon | Contact (sur clinicalTrials) | |||
| Neurology Department, CHU Bordeaux - 33000 - Bordeaux - France | Marie De Montaudouin | Contact (sur clinicalTrials) | |||
| Neurology Department, CHU Strasbourg - 67098 - Strasbourg - France | Edouard Hirsch | Contact (sur clinicalTrials) | |||
| Neuropediatrics department, CHU Angers - 49933 - Angers - France | Patrick Van Bogaert | Contact (sur clinicalTrials) | |||
| Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan - 31059 - Toulouse - France | Luc Valton | Contact (sur clinicalTrials) | |||
| Neurophysiology Department - 75014 - Paris - France | Martine Gavaret | Contact (sur clinicalTrials) | |||
| Neurophysiology Department, CHU Rouen - 76000 - Rouen - France | Nathalie Chastan | Contact (sur clinicalTrials) | |||
| Neurosurgery Department, APHP - 75013 - Paris - France | Bertrand Mathon | Contact (sur clinicalTrials) | |||
| Neurosurgery Department, CHRU Nancy - 54000 - Nancy - France | Sophie Colnat-Coulbois | Contact (sur clinicalTrials) | |||
| Neurosurgery Department, CHU Nantes - 44093 - Nantes - France | Sylvie Raoul | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Male or female epileptic patients over 12 years of age
- Suffering from pharmaco-resistant epilepsy
- With newly implanted VNS Aspire SR device
- Surgery performed in the previous 6 months
- Electrode impedance should be within normal range ( < 4000 Ohms)
- Auto-stim mode working properly
- Mean number of seizures of at least (average 4 (mean value) / months during the
baseline period)
- Patient, parents or legally representatives who have given written informed consent
to allow the study data collection and procedures
- Male or female epileptic patients over 12 years of age
- Suffering from pharmaco-resistant epilepsy
- With newly implanted VNS Aspire SR device
- Surgery performed in the previous 6 months
- Electrode impedance should be within normal range ( < 4000 Ohms)
- Auto-stim mode working properly
- Mean number of seizures of at least (average 4 (mean value) / months during the
baseline period)
- Patient, parents or legally representatives who have given written informed consent
to allow the study data collection and procedures
- Difficulty to read or understand the French language, or inability to understand the
information regarding the study
- Total patient's IQ below 64
- Subject in exclusion period due to enrolment in another study
- Patient with postoperative left vocal cord paralysis
- Patient on VNS since more than 6 months