Clinical trial NCT02648529: Brain Maturation in Children With Localization Related Epilepsy
Official title: Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 101
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Rate of grey/white matter volume
timeFrame: At 5 years
Secondary outcomes:
measure: Changes in fMRI activation of language areas in brain during cognitive tasks
timeFrame: At 5 years
measure: Changes in fMRI activation of social cognition areas in brain during cognitive tasks
timeFrame: At 5 years
measure: Changes in fMRI activation of Working memory areas in brain during cognitive tasks
timeFrame: At 5 years
measure: Changes in fMRI activation of declarative memory areas in brain during cognitive tasks
timeFrame: At 5 years
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel
Study officials:
affiliation: Service d'épileptologie fonctionnelle, Hôpital Pierre Wertheimer, Hospices Civils de Lyon
name: Sylvain RHEIMS
role: PRINCIPAL_INVESTIGATOR
References: