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临床试验/NCT02648529
NCT02648529已完成不适用

Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2008年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Rate of grey/white matter volume

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •associated neurological and psychiatric diseases
  • •other epileptic syndromes
  • •other chronic severe disease
  • •contra-indication for performing an MRI examination
  • •claustrophobia

研究组 & 干预措施

Patients with BCECTS

Experimental

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

干预措施: MRI (Procedure)

Patients with BCECTS

Experimental

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

干预措施: functional MRI (fMRI) (Procedure)

Patients with BCECTS

Experimental

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

干预措施: neuropsychological assessment (Behavioral)

Healthy volunteers

Other

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

干预措施: MRI (Procedure)

Healthy volunteers

Other

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

干预措施: functional MRI (fMRI) (Procedure)

Healthy volunteers

Other

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

干预措施: neuropsychological assessment (Behavioral)

结局指标

主要结局

Rate of grey/white matter volume

时间窗: 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.

次要结局

  • Changes in fMRI activation of declarative memory areas in brain during cognitive tasks(At 5 years)
  • Changes in fMRI activation of language areas in brain during cognitive tasks(At 5 years)
  • Changes in fMRI activation of Working memory areas in brain during cognitive tasks(At 5 years)
  • Changes in fMRI activation of social cognition areas in brain during cognitive tasks(At 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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