Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy
Recruiting · NCT06105645 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
11 locations listed.
- 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