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

Recruiting now · Not applicable

Conditions studied: Epilepsy

In brief

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 facts

Study ID

NCT06105645

Run by

University Hospital, Toulouse

People needed

440

Starts

2024-01-19

Expected to finish

2030-04-01

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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 .
• Patient in exclusion period of another study.
• No other non-inclusion criteria since the study will only be proposed to patients who already meet the criteria for a SEEG

Where it is running

• University Hospital of Toulouse — Toulouse, France (enrolling)
• University hospital of Bordeaux — Bordeaux, France (enrolling)
• University hospital of Grenoble Alpes — La Tronche, France (enrolling)
• APHP Hôpital Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
• CHU de Lille — Lille, France (enrolling)
• Hospices Civils de Lyon — Lyon, France (enrolling)
• CHRU de Nancy — Nancy, France (enrolling)
• CHU Amiens Picardie — Amiens, France (enrolling)
• CHU de Rennes — Rennes, France (enrolling)
• Hôpitaux universitaires de Strasbourg — Strasbourg, France (enrolling)
• Fondation Adolphe de Rothschild — Paris, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.