Evaluating fast-ripples in managing drug-refractory epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess how fast-ripple information can enhance the neurosurgical management of patients with drug-refractory epilepsy using Stereo-ElectroEncephaloGraphy (SEEG). It involves two groups of patients: one receiving hybrid micro-macro electrodes that allow for fast-ripple assessment, and a control group receiving standard electrodes without this capability. The study will analyze the impact of fast-ripples on surgical decisions and patient outcomes, specifically focusing on seizure freedom one year post-surgery. A total of 440 patients will be involved across multiple centers, with data collected and analyzed by a team of experts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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
* 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's running

• CHU Amiens Picardie
  Amiens, France Recruiting
• University hospital of Bordeaux
  Bordeaux, France Recruiting
• University hospital of Grenoble Alpes
  La Tronche, France Recruiting
• APHP Hôpital Bicêtre
  Le Kremlin-Bicêtre, France Recruiting
• CHU de Lille
  Lille, France Recruiting
• Hospices Civils de Lyon
  Lyon, France Recruiting

Study contacts

• Principal investigator: Luc VALTON, MD — University Hospital, Toulouse
• Study coordinator: Luc VALTON, MD
• Email: valton.l@chu-toulouse.fr
• Phone: 0561775608

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.