Brain Maturation in Children With Localization Related Epilepsy

Not Applicable

Completed

• Conditions: Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS); Focal Cryptogenic Epilepsy of Childhood; Cryptogenic Epilepsy of Childhood
• Interventions: Procedure: MRI; Procedure: functional MRI (fMRI); Behavioral: neuropsychological assessment

• Registration Number: NCT02648529
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Status Verified: 2018-12
• Primary Completion: 2018-12-07
• Study Completion: 2018-12-07
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with BCECTS	functional MRI (fMRI)	Patients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed
Patients with BCECTS	neuropsychological assessment	Patients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed
Healthy volunteers	MRI	Healthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed
Healthy volunteers	functional MRI (fMRI)	Healthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed
Healthy volunteers	neuropsychological assessment	Healthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed
Patients with BCECTS	MRI	Patients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed

Primary Outcome Measures

Name	Time	Method
Rate of grey/white matter volume	At 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Changes in fMRI activation of declarative memory areas in brain during cognitive tasks	At 5 years	The aim is to evaluate Functional Brain Maturation of declarative memory. All subjects will benefit from the functional MRI (fMRI) evaluation of the cognitive tasks. Changes in fMRI activation over time will be studied at the group level, taking into account all potentially relevant variables. This outcomme will be assessed at year 1, 3 and 5 after inclusion.
Changes in fMRI activation of language areas in brain during cognitive tasks	At 5 years	The aim is to evaluate functional brain maturation of language. All subjects will benefit from the functional MRI (fMRI) evaluation of the cognitive tasks. Changes in fMRI activation over time will be studied at the group level, taking into account all potentially relevant variables. This outcomme will be assessed at year 1, 3 and 5 after inclusion.
Changes in fMRI activation of Working memory areas in brain during cognitive tasks	At 5 years	The aim is to evaluate Functional Brain Maturation of Working memory. All subjects will benefit from the functional MRI (fMRI) evaluation of the cognitive tasks. Changes in fMRI activation over time will be studied at the group level, taking into account all potentially relevant variables. This outcomme will be assessed at year 1, 3 and 5 after inclusion.
Changes in fMRI activation of social cognition areas in brain during cognitive tasks	At 5 years	The aim is to evaluate functional Brain Maturation of social cognition. All subjects will benefit from the functional MRI (fMRI) evaluation of the cognitive tasks. Changes in fMRI activation over time will be studied at the group level, taking into account all potentially relevant variables. This outcomme will be assessed at year 1, 3 and 5 after inclusion.

Trial Locations

Locations (1)

Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel; 🇫🇷 Bron, France