Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05527093

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-03-21

20

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating social cognition, which is the ability to understand and respond to social information, in patients with drug-resistant medial temporal lobe epilepsy. This condition can impair social cognition, leading to a reduced quality of life. The study aims to map the structure and function of the social cognition network in 20 healthy individuals and 20 patients before and one year after epilepsy surgery to better understand how these networks are affected and reorganized. Participants will undergo detailed neuropsychological testing using a validated French assessment tool for social cognition. Brain scans will be performed using a 3-Tesla MRI to examine brain structure and white matter tracts involved in social cognition, and a 7-Tesla MRI to assess brain activity at rest and during social cognition tasks. These assessments will be done before surgery and repeated one year after surgery to observe changes. During the study, participants will have clinical and cognitive evaluations, along with advanced MRI scans to measure brain structure and function. Researchers will analyze changes in white matter tracts and brain activation related to social cognition. The primary outcomes include measures of brain tract integrity and functional MRI signals, with follow-up assessments to monitor network reorganization after epilepsy surgery. The total study duration extends to at least one year post-surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Good understanding of written and verbal French language
  • Signed written consent
  • Patients with focal temporal lobe epilepsy for at least one year, drug-resistant due to hippocampal sclerosis
  • Undergoing presurgical assessment
  • Affiliated to a social security system
Not Eligible

You will not qualify if you...

  • Under juridical protection
  • Claustrophobia or any contraindication to MRI
  • Pregnancy or lactation
  • Participation in another research study with an exclusion period
  • Refusal to be notified of anomalies found during MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Preoperative Assessment

Duration - Up to several weeks during pre-surgical evaluation

Participants undergo neuropsychological assessments and MRI scans including 3T structural MRI and 7T functional MRI to map social cognition networks before epilepsy surgery.

1 baseline visit with MRI scans and neuropsychological testing

Epilepsy Surgery

Duration - Single day procedure with immediate post-operative care

Participants undergo epilepsy surgery as part of their clinical care.

1 surgery visit

Post-operative Follow-up and Assessment

Duration - 1 year after surgery

Participants have a clinical evaluation, neuropsychological testing, and repeat MRI scans to assess social cognition network reorganization one year after surgery.

1 follow-up visit with MRI scans and neuropsychological assessment

Trial Site Locations

Total: 2 locations

1

NeuroSpin - CEA

Gif-sur-Yvette, France, 91191

Active, Not Recruiting

2

Unité d'épilepsie - GHU Pitié Salpêtrière

Paris, France, 75013

Actively Recruiting

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Research Team

B

Bastien HERLIN, MD, PH

S

Sophie DUPONT, MD,PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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