NCT05527093Recruiting
Cartography of Social Cognition Network and Their Alterations in Patients With Epilepsy
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 Jul 2022
- Start date
- 19 Mar 2025
- Primary completion date
- 19 Jan 2029
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Epilepsy
- NCT number
- NCT05527093
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 19 Mar 2025 to the primary completion date, 19 Jan 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NeuroSpin - CEA Coordinator of this site? Confirm its status | Gif-sur-Yvette | France | Active, not recruiting |
| Unité d'épilepsie - GHU Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.