Investigating brain activity in epilepsy patients using implanted electrodes
Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
This study is testing how brain activity in patients with hard-to-treat epilepsy can help us understand their seizures and how it affects their thinking and sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Paris) |
| Trial ID | NCT04653012 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the mechanisms of epileptic activities by utilizing both macro and micro intracranial electrodes in patients with focal drug-resistant epilepsy who are undergoing pre-surgical evaluation. The study will involve recording brain activity to gain insights into physiological processes such as sleep and cognitive functions. By analyzing these recordings, researchers hope to better understand the neurophysiology of epilepsy and its impact on cognitive abilities.
Who should consider this trial
Good fit: Ideal candidates include adults with focal drug-resistant epilepsy who are undergoing presurgical evaluation with intracranial electrodes.
Not a fit: Patients with contraindications for intracranial investigations or those who are pregnant, breastfeeding, or minors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with drug-resistant epilepsy.
How similar studies have performed: Other studies using similar intracranial electrode approaches have shown promise in understanding epilepsy, but this specific multi-level approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with focal drug-resistant epilepsy * Patients who undergo a presurgical evaluation with intracranial electrodes in the videoEEG unit of the Neurology department at the Pitié-Salpêtrière hospital. * Patients who have been informed and provided written informed consent to take part in the study Exclusion Criteria: * Contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy) * Pregnant or parturient woman * Breastfeeding woman * Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)
Where this trial is running
Paris
- Hôpital de la Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Vincent Navarro
- Email: vincent.navarro@aphp.fr
- Phone: 01 42 16 19 40
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.