Using virtual software to improve epilepsy surgery outcomes
Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP)
NA · Assistance Publique Hopitaux De Marseille · NCT03643016
This study is testing whether using virtual software can help improve surgery outcomes for people with epilepsy that doesn't respond to medication.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 356 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 1 site (Marseille) |
| Trial ID | NCT03643016 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the management and prognosis of patients with drug-resistant focal epilepsy by utilizing virtual epileptic patient software. The approach involves a comprehensive presurgical evaluation that includes non-invasive data collection methods such as video-EEG recordings, neuroimaging, and neuropsychological assessments. If necessary, patients may undergo invasive monitoring with intracerebral EEG to better localize the epileptogenic zone. The goal is to improve the success rate of epilepsy surgery, which currently stands at around 50%.
Who should consider this trial
Good fit: Ideal candidates are patients or pediatric patients suffering from drug-resistant focal epilepsy who require presurgical evaluation.
Not a fit: Patients who have already undergone epilepsy surgery without the need for SEEG or have contraindications to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the rate of seizure freedom in patients undergoing epilepsy surgery.
How similar studies have performed: Other studies have explored innovative approaches to epilepsy surgery, but the use of virtual software in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient or pediatric patient suffering from drug-resistant focal epilepsy. * Standardized presurgical evaluation including medical history, scalp video-EEG, 3T MRI (DTI and rsMRI), FDG-PET, Neuropsychological tests. * Inpatient in one of the participating centers for recording seizure during long term SEEG-monitoring. Exclusion Criteria: * Epilepsy surgery performed without the requirement of SEEG or contra-indication to epilepsy surgery.
Where this trial is running
Marseille
- Assistance Publique Hopitaux de Marseille — Marseille, France (RECRUITING)
Study contacts
- Study coordinator: Fabrice Bartolomei, MD/PhD
- Email: fabrice.bartolomei@ap-hm.fr
- Phone: +33491385829
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.
Conditions: Epilepsy