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Recruiting Not applicable

Cartography of Social Cognition Network and Their Alterations in Patients With Epilepsy

NCT05527093 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-03-19
Last updated
2025-03-21

Condition(s) studied

EpilepsyDrug Resistant Epilepsy

Investigational drug(s) / intervention(s)

MRI 3T and MRI 7T

MRI 3T and MRI 7T: MRI 3T and MRI 7T before and post epilepsy surgery

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Measure of fractional anisotropy (scalar parameters, between 0 and 1) of long and short white-matter tracts involved in social cognition, in healthy subjects and patients with epilepsy — 12 months
    fractional anisotropy (scalar parameters, between 0 and 1)
  • measure of mean diffusivity (in mm2/s) of long and short white matter tracts involved in social cognition, in healthy subjects and patients with epilepsy — 12 months
    mean diffusivity (in mm2/s)
  • number of fibers in each long and white matter tracts involved in social cognition — 12 months
    number of fibers in each long and white matter tracts involved in social
  • angular dispersion (degree/m) of axons in long and short white matter tracts involved in social cognition, in healthy subjects and patients with epilepsy — 12 months
    angular dispersion (degree/m) of axons
  • measure of functional MRI (fMRI) cortical activations in social cognition networks (measure : % of BOLD signal change), in healthy subjects and patients with epilepsy — 12 months
    (measure : % of blood-oxygen-level-dependent (BOLD) signal change)

Trial sites (2)

FacilityCityRegionStatus
NeuroSpin - CEA Gif-sur-Yvette France Active Not Recruiting
Unité d'épilepsie - GHU Pitié Salpêtrière Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05527093 on ClinicalTrials.gov ↗ ← All trials in France