Evaluating fast-ripples in managing drug-refractory epilepsy
Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy
This study is testing whether using special electrodes to track fast-ripples in the brain can help doctors make better surgery decisions for people with epilepsy that doesn't respond to medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 11 sites (Amiens and 10 other locations) |
| Trial ID | NCT06105645 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients suffering from drug-resistant focal epilepsy who are undergoing SEEG and have consented to participate.
Not a fit: Patients with conditions such as cardiac defibrillators or those under judicial protection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better seizure control for patients with drug-refractory epilepsy.
How similar studies have performed: While the use of fast-ripples in epilepsy management is a novel approach, similar studies have shown promising results in enhancing surgical decision-making.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 this trial is running
Amiens and 10 other locations
- 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)
- CHRU de Nancy — Nancy, France (Recruiting)
- Fondation Adolphe de Rothschild — Paris, France (Not_yet_recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
- Hôpitaux universitaires de Strasbourg — Strasbourg, France (Recruiting)
- University Hospital of Toulouse — Toulouse, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.