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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens Picardie
RECRUITING
Amiens
University hospital of Bordeaux
RECRUITING
Bordeaux
University hospital of Grenoble Alpes
RECRUITING
La Tronche
APHP Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
CHU de Lille
RECRUITING
Lille
Hospices Civils de Lyon
RECRUITING
Lyon
CHRU de Nancy
RECRUITING
Nancy
Fondation Adolphe de Rothschild
NOT_YET_RECRUITING
Paris
CHU de Rennes
RECRUITING
Rennes
Hôpitaux universitaires de Strasbourg
RECRUITING
Strasbourg
University Hospital of Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Luc VALTON, MD
valton.l@chu-toulouse.fr
0561775608
Backup
Yoan HERADES
yoan.herades@inserm.fr
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2030-04
Participants
Target number of participants: 440
Treatments
Experimental: 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
Active_comparator: Arm without fast-ripples information
Patients who will undergo an SEEG with the usual electrodes and for whom fast-ripples will not be assessed.
Related Therapeutic Areas
Sponsors
Collaborators: Dixi Medical, Centre de recherche Cerveau et Cognition (CERCO)
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov