Brain Maturation in Children With Localization Related Epilepsy

NCT ID: NCT02648529

Last Updated: 2018-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2018-12-07

Brief 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.

Conditions

Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS); Focal Cryptogenic Epilepsy of Childhood; Cryptogenic Epilepsy of Childhood

Keywords

Benign childhood epilepsy with centro-temporal spikes; rolandic epilepsy; brain development; DTI; functional MRI; structural MRI; idiopathic focal epilepsy; cryptogenic epilepsy of childhood

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients with BCECTS

Patients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed

Group Type: EXPERIMENTAL

MRI

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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

Intervention Type: BEHAVIORAL

Patients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project.

Healthy volunteers

Healthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed

Group Type: OTHER

MRI

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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

Intervention Type: BEHAVIORAL

Patients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project.

Interventions

MRI

Patients are investigated with the following sequences:

• High-resolution 3D T1-weighted anatomical MRI.
• DTI with 48 directions (to examine white matter)

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

neuropsychological assessment

Patients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvain RHEIMS

Role: PRINCIPAL_INVESTIGATOR

Service d'épileptologie fonctionnelle, Hôpital Pierre Wertheimer, Hospices Civils de Lyon

Locations

Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel

Bron, , France

Countries

France

Other Identifiers

2011-700

Identifier Type: -

Identifier Source: org_study_id