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

NCT05527093 | Recruiting

• 2 other identifiers: APHP2200432022-A01374-39
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy; Drug Resistant Epilepsy

Keywords

epilepsy; hippocampal sclerosis; social cognition

Outcome Measures

Primary Outcomes (5)

• 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

  fractional anisotropy (scalar parameters, between 0 and 1)

  12 months

• 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

  mean diffusivity (in mm2/s)

  12 months

• number of fibers in each long and white matter tracts involved in social cognition

  number of fibers in each long and white matter tracts involved in social

  12 months

• angular dispersion (degree/m) of axons in long and short white matter tracts involved in social cognition, in healthy subjects and patients with epilepsy

  angular dispersion (degree/m) of axons

  12 months

• measure of functional MRI (fMRI) cortical activations in social cognition networks (measure : % of BOLD signal change), in healthy subjects and patients with epilepsy

  (measure : % of blood-oxygen-level-dependent (BOLD) signal change)

  12 months

Secondary Outcomes (5)

• Measure of fractional anisotropy (scalar parameters, between 0 and 1) of long and short white-matter tracts involved in social cognition in patients with epilepsy 1year after surgery

  24 months

• Measure of mean diffusivity (in mm2/s) of long and short white matter tracts involved in social cognition, in patients with epilepsy 1 year after surgery

  24 months

• Number of fibers in each long and white matter tracts involved in social cognition

  24 months

• Angular dispersion (degree/m) of axons in long and short white matter tracts involved in social cognition, in patients with epilepsy 1 year after surgery

  24 months

• Measure of fMRI cortical activations in social cognition networks (measure : % of BOLD signal change), in patients with epilepsy 1 year after surgery

  24 months

Study Arms (1)

Patients with focal temporal lobe epilepsy for at least one year, drug-resistant

EXPERIMENTAL

Radiation: MRI 3T and MRI 7T

Interventions

MRI 3T and MRI 7T RADIATION

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

Patients with focal temporal lobe epilepsy for at least one year, drug-resistant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under juridical protection
• With claustrophobia or any MRI contra-indication
• Pregnancy or lactation
• Refusal to be notified in the event of anomalies discovered during the performance of an MRI sequence

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

NeuroSpin - CEA

Gif-sur-Yvette, 91191, France

ACTIVE NOT RECRUITING

Unité d'épilepsie - GHU Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy; Hippocampal Sclerosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Bastien HERLIN, MD, PH

CONTACT

1 42 16 03 01; bastien.herlin@php.fr

Sophie DUPONT, MD,PHD

CONTACT

1 42 16 03 01; sophie.dupont@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: September 2, 2022
• Study Start: March 19, 2025
• Primary Completion (Estimated): January 19, 2029
• Study Completion (Estimated): January 19, 2029
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

FR (2)