Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy
NENUFAR
2 other identifiers
interventional
440
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
January 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
September 22, 2025
September 1, 2025
6.2 years
October 23, 2023
September 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contribution of fast-ripples information on freedom seizures
Proportion of patients with Engel class I after one-year post-surgery in the group of patients with information of fast-ripples compared to patients without.
12 months after epilepsy surgery
Secondary Outcomes (11)
Contribution of fast-ripples information on improvement of epilepsy
12 months after epilepsy surgery
Contribution of fast-ripples information on patients addressed to neurosurgery
12 months after epilepsy surgery
Adverse effects related to Stereo-electroencephalography
Day 0 (SEEG visit)
Adverse effects of epilepsy surgery
6 months after surgical decision
Adverse effects of hybrid electrodes
Day 0 (SEEG visit)
- +6 more secondary outcomes
Study Arms (2)
Arm with fast-ripples information
EXPERIMENTALPatients for whom 4-6 usual clinical macro-electrodes will be replaced by hybrid micro-macro electrodes and for whom fast-ripples will be assessed
Arm without fast-ripples information
ACTIVE COMPARATORPatients who will undergo an SEEG with the usual electrodes and for whom fast-ripples will not be assessed.
Interventions
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.
Standard electrodes used usually during the SEEG
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- Centre de recherche Cerveau et Cognition (CERCO)collaborator
- Dixi Medicalcollaborator
Study Sites (11)
CHU Amiens Picardie
Amiens, France
University hospital of Bordeaux
Bordeaux, 33076, France
University hospital of Grenoble Alpes
La Tronche, 38700, France
APHP Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
CHU de Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
CHRU de Nancy
Nancy, France
Fondation Adolphe de Rothschild
Paris, 75019, France
CHU de Rennes
Rennes, France
Hôpitaux universitaires de Strasbourg
Strasbourg, France
University Hospital of Toulouse
Toulouse, 31059, France
Related Publications (1)
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: 32389603BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc VALTON, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2023
First Posted
October 27, 2023
Study Start
January 19, 2024
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
April 1, 2030
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share