Overview

This trial is active, not recruiting.

Conditions benign childhood epilepsy with centro-temporal spikes (bcects), focal cryptogenic epilepsy of childhood, cryptogenic epilepsy of childhood
Treatments mri, functional mri (fmri), neuropsychological assessment
Sponsor Hospices Civils de Lyon
Start date September 2008
End date July 2020
Trial size 101 participants
Trial identifier NCT02648529, 2011-700

Summary

This project intends to investigate children with idiopathic and cryptogenic localization related epilepsies, using a longitudinal assessment of structural and functional MRI data, in relation to neuropsychological evaluation. The rationale is primarily based on: 1) the frequent observation of selective cognitive dysfunctions in such children, the pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI investigation of brain maturation showing striking age and region dependant patterns.

The primary hypothesis is that some children with localization related epilepsies suffer from altered maturation in the epileptic brain regions, and that this abnormal maturation affects their cognitive abilities. 100 children with localization related epilepsies and 100 matched controls will be prospectively enrolled during the first two years of the disease (for patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation once a year for 5 years. The brain maturation of these children will be longitudinally assessed using structural and functional MRI, and correlated with neuropsychological data. Investigators hope to demonstrate that children with localization related epilepsies and cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the epileptic activity and the altered cognitive processes. The finding could partly bridge the gap between these two abnormalities and help better understand their interaction and respective dynamic. Once validated, the study of regional brain maturation in children with epilepsy might be further used as a reliable surrogate marker or predictor of associated cognitive dysfunction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Patients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed
mri
Patients are investigated with the following sequences: High-resolution 3D T1-weighted anatomical MRI. DTI with 48 directions (to examine white matter)
functional mri (fmri)
fMRI investigations will be focused on : language: investigation on possible atypical language networks in children with epilepsy. The fMRI task is a silent verb generation. Social cognition: investigations on social cognition skills Memory : Declarative memory: investigations on the pattern of activations in the brain associated with successful memory formation and changes from childhood to adolescence Working memory: A verbal and a spatial working memory task has been chosen, and is an adaptation of two published cross-sectional studies of working memory from Gabrieli and Sowell groups.
neuropsychological assessment
Patients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project.
(Other)
Healthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed
mri
Patients are investigated with the following sequences: High-resolution 3D T1-weighted anatomical MRI. DTI with 48 directions (to examine white matter)
functional mri (fmri)
fMRI investigations will be focused on : language: investigation on possible atypical language networks in children with epilepsy. The fMRI task is a silent verb generation. Social cognition: investigations on social cognition skills Memory : Declarative memory: investigations on the pattern of activations in the brain associated with successful memory formation and changes from childhood to adolescence Working memory: A verbal and a spatial working memory task has been chosen, and is an adaptation of two published cross-sectional studies of working memory from Gabrieli and Sowell groups.
neuropsychological assessment
Patients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project.

Primary Outcomes

Measure
Rate of grey/white matter volume
time frame: At 5 years

Secondary Outcomes

Measure
Changes in fMRI activation of language areas in brain during cognitive tasks
time frame: At 5 years
Changes in fMRI activation of social cognition areas in brain during cognitive tasks
time frame: At 5 years
Changes in fMRI activation of Working memory areas in brain during cognitive tasks
time frame: At 5 years
Changes in fMRI activation of declarative memory areas in brain during cognitive tasks
time frame: At 5 years

Eligibility Criteria

Male or female participants from 6 years up to 16 years old.

Inclusion Criteria: - motivation to participate in the study for 5 years - for patients - one of the following diagnostics - BCECTS (benign childhood epilepsy with centro-temporal spikes), focal cryptogenic epilepsy of childhood, Panayiotopoulos syndrome, diagnosis established according to the current diagnostic criteria (ILAE, 1989) - for patients - no anti-epileptic drug for 24 months - normal MRI if available before inclusion - signed consent by on of the parents Exclusion Criteria: - associated neurological and psychiatric diseases - other epileptic syndromes - other chronic severe disease - contra-indication for performing an MRI examination - claustrophobia

Additional Information

Official title Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy
Principal investigator Sylvain RHEIMS
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.