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RECRUITING
NCT06105645
NA

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

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2024-01-19

Completion Date

2030-04

Last Updated

2025-09-22

Healthy Volunteers

No

Conditions

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

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