Brain Maturation in Children With Localization Related Epilepsy

NCT02648529 | Completed

• 1 other identifier: 2011-700
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of grey/white matter volume

  The aim is to evaluate structural brain maturation. All subjects will benefit from a 3D-T1 1,5 Tesla MRI and 48-directions Diffusion Tensor Imaging (DTI). We will calculate parametric maps of individual regional changes of grey/white matter fractions over time. This study aims to detect a significant difference in the rate of grey/white matter volume change over the epileptic region. We will further correlate a number of neuropsychological and clinical variables with the parametric maps of brain maturation. There will be annual measures up to 5 years after inclusion.

  At 5 years

Secondary Outcomes (4)

• Changes in fMRI activation of language areas in brain during cognitive tasks

  At 5 years

• Changes in fMRI activation of social cognition areas in brain during cognitive tasks

  At 5 years

• Changes in fMRI activation of Working memory areas in brain during cognitive tasks

  At 5 years

• Changes in fMRI activation of declarative memory areas in brain during cognitive tasks

  At 5 years

Study Arms (2)

Patients with BCECTS

EXPERIMENTAL

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

Procedure: MRI; Procedure: functional MRI (fMRI); Behavioral: neuropsychological assessment

Healthy volunteers

OTHER

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

Procedure: MRI; Procedure: functional MRI (fMRI); Behavioral: neuropsychological assessment

Interventions

MRI PROCEDURE

Patients are investigated with the following sequences: * High-resolution 3D T1-weighted anatomical MRI. * DTI with 48 directions (to examine white matter)

Healthy volunteers; Patients with BCECTS

functional MRI (fMRI) 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.

Healthy volunteers; Patients with BCECTS

neuropsychological assessment BEHAVIORAL

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

Healthy volunteers; Patients with BCECTS

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• signed consent by on of the parents

You may not qualify if:

• associated neurological and psychiatric diseases
• other epileptic syndromes
• other chronic severe disease
• contra-indication for performing an MRI examination
• claustrophobia

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel

Bron, 69677, France

Location

MeSH Terms

Conditions

Epilepsy, Rolandic

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Sylvain RHEIMS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: January 7, 2016
• Study Start: September 1, 2008
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

FR (1)