NCT05527093 Cartography of Social Cognition Network and Their Alterations in Patients With Epilepsy
| NCT ID | NCT05527093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2029-01-19 |
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 20 participants in total. It began in 2025-03-19 with a primary completion date of 2029-01-19.
⚠ 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
Social cognition, which refers to the ability to interpret social information and behave accordingly in a social environment, is crucial in everyday life. But this ability has been shown to be altered in patients with epilepsy, especially in medial temporal lobe epilepsy, which leads to a deterioration in the patient's quality of life. However, the mechanisms of those deficiencies remain largely unknown. The Team objective is to achieve a structural and functional cartography of the social cognition network in 20 healthy subjects and 20 patients with drug-resistant medial temporal lobe epilepsy (before and one year after resective surgery of the epileptogenic focus). Social cognition deficiencies will be assessed using a specifically dedicated neuropsychological assessment validated in French (Batteries de Cognition Sociale BCS). Brain structural analyses will be performed on a 3-Tesla MRI (3T MRI), including an anatomical T1 sequence, a High Angular Resolution Diffusion Imaging (HARDI) to assess the morphology and macrostructural characteristics of long and short white matter tracts involved in social cognition, and quantitative MRI and Hybrid Diffusion Imaging (HYDI) to assess their microstructure. Functional connectivity will be assessed using an ultra-high-field 7-Tesla MRI (7T MRI), with acquisition in resting state and during specific social cognition tasks. Joint analysis of structural and functional connectivity will enable the team to assess the alterations of social cognition networks in patients with epilepsy and their reorganisations after epilepsy surgery.
Eligibility Criteria
Inclusion criteria: * Age ≥ 18 years old * Good understanding of written and verbal French language * Written consent signed by the subject * Patients with focal temporal lobe epilepsy for at least one year, drug-resistant, due to a hippocampal sclerosis * Undergoing presurgical assessment * Affiliated to a social security system Exclusion criteria: * Under juridical protection * With claustrophobia or any MRI contra-indication * Pregnancy or lactation * Participation in another research with an exclusion period * Refusal to be notified in the event of anomalies discovered during the performance of an MRI sequence
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05527093 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 NCT05527093 currently recruiting?
Yes, NCT05527093 is actively recruiting participants. Contact the research team at bastien.herlin@php.fr for enrollment information.
Where is the NCT05527093 trial being conducted?
This trial is being conducted at Gif-sur-Yvette, France, Paris, France.
Who is sponsoring the NCT05527093 clinical trial?
NCT05527093 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 20 participants.
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