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Brain Maturation in Children With Localization Related Epilepsy (DYNAMAT)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

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

Treatments

Procedure: MRI
Procedure: functional MRI (fMRI)
Behavioral: neuropsychological assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT02648529
2011-700

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

6 to 16 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

101 participants in 2 patient groups

Patients with BCECTS
Experimental group
Description:
Patients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed
Treatment:
Procedure: MRI
Behavioral: neuropsychological assessment
Procedure: functional MRI (fMRI)
Healthy volunteers
Other group
Description:
Healthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed
Treatment:
Procedure: MRI
Behavioral: neuropsychological assessment
Procedure: functional MRI (fMRI)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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