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Completed

NCT Number: NCT02648529

Brain Maturation in Children With Localization Related Epilepsy

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.

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Key information

Conditions

Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS) Brain Diseases Central Nervous System Diseases Cryptogenic Epilepsy of Childhood Epilepsies, Partial Epilepsy Epilepsy, Rolandic Epileptic Syndromes Focal Cryptogenic Epilepsy of Childhood Nervous System Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel

Bron, 69677, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

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)

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

Behavioral

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

Primary outcomes

  1. Rate of grey/white matter volume

    Time frame: 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 outcomes

  1. Changes in fMRI activation of language areas in brain during cognitive tasks

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy

Acronym: DYNAMAT

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2016
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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