RecruitingNot ApplicableNCT06105645

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


Sponsor

University Hospital, Toulouse

Enrollment

440 participants

Start Date

Jan 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEDIXI 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.

DEVICEStandard 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06105645


Related Trials