Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS) Clinical Trial
— DYNAMATOfficial title:
Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy
| Verified date | December 2018 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | December 7, 2018 |
| Est. primary completion date | December 7, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 6 Years to 16 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | At 5 years | |
| Secondary | 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. | At 5 years | |
| Secondary | 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. | At 5 years | |
| Secondary | 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. | At 5 years |