Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DIXI Medical Microdeep® Micro- Macro Depth electrodes, Standard electrodes.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Contribution of fast-ripples information on freedom seizures [Time frame: 12 months after epilepsy surgery]
Secondary outcome measures (11)
- Contribution of fast-ripples information on improvement of epilepsy [Time frame: 12 months after epilepsy surgery]
- Contribution of fast-ripples information on patients addressed to neurosurgery [Time frame: 12 months after epilepsy surgery]
- Adverse effects related to Stereo-electroencephalography [Time frame: Day 0 (SEEG visit)]
- Adverse effects of epilepsy surgery [Time frame: 6 months after surgical decision]
- Adverse effects of hybrid electrodes [Time frame: Day 0 (SEEG visit)]
- Post-operative neurological deficit [Time frame: 12 months after epilepsy surgery]
- Evolution of quality of life using the score of Quality of life Epilepsy Inventory Epilepsy Inventory [Time frame: 12 months after epilepsy surgery]
- Level of satisfaction [Time frame: 12 months after epilepsy surgery]
- Recording of fast-ripples [Time frame: Day 0 (SEEG visit)]
- Distribution of the fast-ripples [Time frame: Day 0 (SEEG visit)]
- Number of fast-ripples recorded according to the period [Time frame: Day 0 (SEEG visit)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 11 centers
- CHU Amiens Picardie — Amiens
- University hospital of Bordeaux — Bordeaux
- University hospital of Grenoble Alpes — La Tronche
- APHP Hôpital Bicêtre — Le Kremlin-Bicêtre
- CHU de Lille — Lille
- Hospices Civils de Lyon — Lyon
- CHRU de Nancy — Nancy
- Fondation Adolphe de Rothschild — Paris
- … and 3 more centers
Publications
- 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. PMID 32389603
Identifiers
NCT: NCT06105645 · RC31/22/0260 · 2022-A02552-41