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RECRUITINGINTERVENTIONAL

Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The main aim of this study is to evaluate the contribution of fast-ripples (FR) information on the neurosurgery management of patients with drug-refractory epilepsy investigated by Stereo-ElectroEncephaloGraphy (SEEG), as measured by freedom from disabling seizures one-year post-surgery. 220 patients (for whom 4-6 usual clinical macro-electrodes will be replaced by hybrid micro-macro electrodes and for whom fast-ripples will be assessed) distributed over 5 centres and 220 control patients(who will undergo an SEEG with the usual electrodes and for whom fast-ripples will not be assessed) distributed over 6 centres. This is a controlled, non-randomized, parallel plan, prospective, multicentre exploratory study.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient suffering from drug-resistant focal epilepsy (DRFE), as defined by the International League Against Epilepsy, undergoing SEEG, the indication of which was selected during a multidisciplinary epilepsy meeting - Patient who has given written willing to sign a consent form to allow the study data collection procedures - Patient covered by the French healthcare system. Who Should NOT Join This Trial: - Patients under juridical protection (authorship, curators or safeguarding of justice). - Patient deprived of liberty by a judicial or administrative decision - Patient with a cardiac defibrillator - Thermocoagulation planned on one of the potential hybrid electrodes . - Patient in exclusion period of another study. - No other non-inclusion criteria since the study will only be proposed to patients who already meet the criteria for a SEEG Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patient suffering from drug-resistant focal epilepsy (DRFE), as defined by the International League Against Epilepsy, undergoing SEEG, the indication of which was selected during a multidisciplinary epilepsy meeting * Patient who has given written informed consent to allow the study data collection procedures * Patient covered by the French healthcare system. Exclusion Criteria: * Patients under juridical protection (authorship, curators or safeguarding of justice). * Patient deprived of liberty by a judicial or administrative decision * Patient with a cardiac defibrillator * Thermocoagulation planned on one of the potential hybrid electrodes . * Patient in exclusion period of another study. * No other non-inclusion criteria since the study will only be proposed to patients who already meet the criteria for a SEEG

Treatments Being Tested

DEVICE

DIXI Medical Microdeep® Micro- Macro Depth electrodes

It is a deep intracerebral electrode used in the pre-surgical diagnosis of certain drug-resistant epilepsies. It consists of micro- and macro-contacts and is designed for Stereo-ElectroEncephalography (SEEG) recording via the macro-contacts or micro-contacts and brief stimulation via the macro-contacts.

DEVICE

Standard electrodes

Standard electrodes used usually during the SEEG

Locations (11)

CHU Amiens Picardie
Amiens, France
University hospital of Bordeaux
Bordeaux, France
University hospital of Grenoble Alpes
La Tronche, France
APHP Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU de Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
CHRU de Nancy
Nancy, France
Fondation Adolphe de Rothschild
Paris, France
CHU de Rennes
Rennes, France
Hôpitaux universitaires de Strasbourg
Strasbourg, France
University Hospital of Toulouse
Toulouse, France