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

NCT ID: NCT06105645

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2030-04-30

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm with fast-ripples information

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

Group Type: EXPERIMENTAL

DIXI Medical Microdeep® Micro- Macro Depth electrodes

Intervention Type: DEVICE

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.

Arm without fast-ripples information

Patients who will undergo an SEEG with the usual electrodes and for whom fast-ripples will not be assessed.

Group Type: ACTIVE_COMPARATOR

Standard electrodes

Intervention Type: DEVICE

Standard electrodes used usually during the SEEG

Interventions

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.

Intervention Type: DEVICE

Standard electrodes

Standard electrodes used usually during the SEEG

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de recherche Cerveau et Cognition (CERCO)

UNKNOWN

Sponsor Role: collaborator

Dixi Medical

UNKNOWN

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luc VALTON, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Amiens Picardie

Amiens, , France

Site Status: RECRUITING

University hospital of Bordeaux

Bordeaux, , France

Site Status: RECRUITING

University hospital of Grenoble Alpes

La Tronche, , France

Site Status: RECRUITING

APHP Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status: RECRUITING

CHU de Lille

Lille, , France

Site Status: RECRUITING

Hospices Civils de Lyon

Lyon, , France

Site Status: RECRUITING

CHRU de Nancy

Nancy, , France

Site Status: RECRUITING

Fondation Adolphe de Rothschild

Paris, , France

Site Status: NOT_YET_RECRUITING

CHU de Rennes

Rennes, , France

Site Status: RECRUITING

Hôpitaux universitaires de Strasbourg

Strasbourg, , France

Site Status: RECRUITING

University Hospital of Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Luc VALTON, MD

Role: CONTACT

valton.l@chu-toulouse.fr

0561775608 ext. +33

Yoan HERADES

Role: CONTACT

yoan.herades@inserm.fr

Facility Contacts

William SZURHAJ

Role: primary

Véronique MICHEL

Role: primary

Philippe KAHANE

Role: primary

Delphine TAUSSIG

Role: primary

Philippe DERAMBURE

Role: primary

Sylvain RHEIMS

Role: primary

Jacques JONAS

Role: primary

Sinéad ZEIDAN

Role: primary

Dragos-Mihai MALIIA

Role: primary

Edouard HIRSCH

Role: primary

Luc VALTON, MD

Role: primary

valton.l@chu-toulouse.fr

0561775608

Yoan HERADES

Role: backup

yoan.herades@inserm.fr

References

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.

Reference Type: BACKGROUND

PMID: 32389603 (View on PubMed)

Other Identifiers

2022-A02552-41

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/22/0260

Identifier Type: -

Identifier Source: org_study_id