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Brain Maturation in Children With Localization Related Epilepsy (DYNAMAT)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
functional MRI (fMRI)
neuropsychological assessment
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS) focused on measuring Benign childhood epilepsy with centro-temporal spikes, rolandic epilepsy, brain development, DTI, functional MRI, structural MRI, idiopathic focal epilepsy, cryptogenic epilepsy of childhood

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patients with BCECTS

Healthy volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in fMRI activation of language areas in brain during cognitive tasks
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 social cognition areas in brain during cognitive tasks
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.
Changes in fMRI activation of Working memory areas in brain during cognitive tasks
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 declarative memory areas in brain during cognitive tasks
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.

Full Information

First Posted
December 2, 2015
Last Updated
December 20, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02648529
Brief Title
Brain Maturation in Children With Localization Related Epilepsy
Acronym
DYNAMAT
Official Title
Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 7, 2018 (Actual)
Study Completion Date
December 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with BCECTS
Arm Type
Experimental
Arm Description
Patients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
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
Intervention Name(s)
functional MRI (fMRI)
Intervention Description
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
Behavioral
Intervention Name(s)
neuropsychological assessment
Intervention Description
Patients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project.
Primary Outcome Measure Information:
Title
Rate of grey/white matter volume
Description
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.
Time Frame
At 5 years
Secondary Outcome Measure Information:
Title
Changes in fMRI activation of language areas in brain during cognitive tasks
Description
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.
Time Frame
At 5 years
Title
Changes in fMRI activation of social cognition areas in brain during cognitive tasks
Description
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.
Time Frame
At 5 years
Title
Changes in fMRI activation of Working memory areas in brain during cognitive tasks
Description
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.
Time Frame
At 5 years
Title
Changes in fMRI activation of declarative memory areas in brain during cognitive tasks
Description
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.
Time Frame
At 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain RHEIMS
Organizational Affiliation
Service d'épileptologie fonctionnelle, Hôpital Pierre Wertheimer, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

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Brain Maturation in Children With Localization Related Epilepsy

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