Clinical trial NCT06105645: Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy
Official title: Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Fast-ripples
Epilepsy
Neurosurgery
Hybrid electrodes
MICRODEEP® MME hybrid electrodes
StereoEEG
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Centre de recherche Cerveau et Cognition (CERCO)
name: Dixi Medical
First posted: 2023-10-27
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: This is a controlled, non-randomized, parallel plan, prospective, multicentre exploratory study. The design of the study relies on two groups of patients benefiting from a SEEG, equivalent in size: one with standard and hybrid electrodes for which fast-ripple information will be available for the neurosurgery decision, the other, who will serve as a control group, with standard electrodes only and for which no information regarding fast-ripples will be provided. For all patients undergoing SEEG, the decisions about eligibility to epilepsy surgery and, if eligible, about the best surgical plan, are taken during a multidisciplinary epilepsy meeting (MEM) within the 4 +/- 2 months following the SEEG. In the group of patients with standard and hybrid electrodes, the procedure as extensively tested previously, is to plan the implantation of the standard electrodes as usually done, and once done, to replace from 4 to 6 standard electrodes with hybrid electrodes. In this group, intracerebral ElectroEncephaloGraphy (EEG) data will be acquired for detection of fast-ripples, during one hour of a rest period for 2 days during the first week of SEEG, as well as during one cycle of night sleep when possible. Fast-ripples(number, localization and characteristics) for all these patients will be analysed by an expert group of neuroscientists based in Toulouse blind to the analysis of the Epileptogenic Zone (EZ), irritative and propagation zones and on all micro- and macro contacts, to the participating centre and to the period of recording. The results of the fast-ripple assessment will be provided to the clinicians on time for the MEM. They will incorporate this information along other usual clinical information gathered during the SEEG to reach a conclusion regarding the possibility of a neurosurgery. No analysis of the fast-ripples will be performed in the other group of patients with standard electrodes only. In this group, the conclusion regarding the possibility of a neurosurgery will thus be done during the MEM with the standard clinical information gathered during the SEEG only. Following epilepsy surgery, the typical follow-up performed in routine in all participating centres includes a clinical evaluation one year after surgery, during which Engel class is assessed.

Eligibility criteria: 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

Primary outcomes:
measure: Contribution of fast-ripples information on freedom seizures
timeFrame: 12 months after epilepsy surgery
Secondary outcomes:
measure: Contribution of fast-ripples information on improvement of epilepsy
timeFrame: 12 months after epilepsy surgery
measure: Contribution of fast-ripples information on patients addressed to neurosurgery
timeFrame: 12 months after epilepsy surgery
measure: Adverse effects related to Stereo-electroencephalography
timeFrame: Day 0 (SEEG visit)
measure: Adverse effects of epilepsy surgery
timeFrame: 6 months after surgical decision
measure: Adverse effects of hybrid electrodes
timeFrame: Day 0 (SEEG visit)
measure: Post-operative neurological deficit
timeFrame: 12 months after epilepsy surgery
measure: Evolution of quality of life using the score of Quality of life Epilepsy Inventory Epilepsy Inventory
timeFrame: 12 months after epilepsy surgery
measure: Level of satisfaction
timeFrame: 12 months after epilepsy surgery
measure: Recording of fast-ripples
timeFrame: Day 0 (SEEG visit)
measure: Distribution of the fast-ripples
timeFrame: Day 0 (SEEG visit)
measure: Number of fast-ripples recorded according to the period
timeFrame: Day 0 (SEEG visit)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nancy
country: France
facility: CHRU de Nancy
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: Hôpitaux universitaires de Strasbourg
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Luc VALTON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Despouy E, Curot J, Reddy L, Nowak LG, Deudon M, Sol JC, Lotterie JA, Denuelle M, Maziz A, Bergaud C, Thorpe SJ, Valton L, Barbeau EJ. Recording local field potential and neuronal activity with tetrodes in epileptic patients. J Neurosci Methods. 2020 Jul 15;341:108759. doi: 10.1016/j.jneumeth.2020.108759. Epub 2020 May 7.