Mapping the anterior temporal lobe in patients with drug-resistant epilepsy
Pre-operative Mapping of the Anterior Temporal Lobe Using Functional MRI Innovative Techniques in in Drug-resistant Epileptic Patients
This study tests a new way to map the brain in people with drug-resistant epilepsy to help doctors find the best spot to operate and reduce risks of side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy) |
| Trial ID | NCT05339438 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with drug-resistant anterior temporal lobe epilepsy, which is a common form of focal epilepsy. It aims to utilize functional MRI techniques to accurately map the anterior temporal lobe before surgical intervention, specifically anterior temporal lobectomy. The mapping is crucial for identifying the epileptic focus while minimizing the risk of neurological and cognitive deficits post-surgery. The study also includes healthy volunteers for comparison purposes.
Who should consider this trial
Good fit: Ideal candidates are adults with drug-resistant structural focal epilepsy of the anterior temporal lobe who are considering epilepsy surgery.
Not a fit: Patients who are not candidates for surgery or have contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes for patients with drug-resistant epilepsy by reducing the risk of cognitive decline.
How similar studies have performed: Other studies utilizing functional MRI for pre-surgical mapping in epilepsy have shown promising results, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult person, * Person affiliated to a social security scheme or beneficiary of such a scheme, * Person having received complete information on the organization of the Clinical Investigation and having signed informed consent, * Person having carried out a preliminary clinical examination adapted to the Clinical Investigation, * For patients: Person with drug-resistant structural focal epilepsy of the anterior temporal lobe (right or left), candidate for epilepsy surgery (anterior temporal lobectomy), * For healthy volunteers: Person with no known pathology in the anterior temporal lobe (particularly epilepsy). Exclusion Criteria: * Contraindication to MRI including claustrophobia, * Uncorrected visual disturbances, * Person unable to give consent, * Lack of mastery of the French language or ability to understand instructions, * Person referred to in Articles 64, 65 and 66 of European Regulation 2017/745: Person of full age unable to consent alone to participate in the Clinical Investigation; Minor; Pregnant or breastfeeding woman.
Where this trial is running
Nancy
- Centre Hospitalier Régional Universitaire de Nancy — Nancy, France (Recruiting)
Study contacts
- Study coordinator: Jacques JONAS
- Email: j.jonas@chru-nancy.fr
- Phone: +33383852377
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.