NCT06105645 Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy
| NCT ID | NCT06105645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2024-01-19 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Luc VALTON, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06105645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105645 currently recruiting?
Yes, NCT06105645 is actively recruiting participants. Contact the research team at valton.l@chu-toulouse.fr for enrollment information.
Where is the NCT06105645 trial being conducted?
This trial is being conducted at Amiens, France, Bordeaux, France, La Tronche, France, Le Kremlin-Bicêtre, France and 7 additional locations.
Who is sponsoring the NCT06105645 clinical trial?
NCT06105645 is sponsored by University Hospital, Toulouse. The principal investigator is Luc VALTON, MD at University Hospital, Toulouse. The trial plans to enroll 440 participants.
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