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临床试验/NCT00894478
NCT00894478已完成不适用

Improving Lesion Detection in Children With MRI-negative Partial Epilepsy Using Diffusion Tensor Imaging

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Identify DTI changes in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD using voxel-by-voxel analysis of FA and MD maps compared to normal controls.

研究概览

简要总结

Focal cortical dysplasia is one of the most common lesions responsible for medically refractory epilepsy in the pediatric population. In patients with medically intractable epilepsy, surgery is the only treatment that will lead to seizure freedom. The outcome of epilepsy surgery is worse in patients when there is no lesion identified on routine structural MRI, also known as MRI-negative partial epilepsy. Diffusion tensor imaging (DTI), a novel MRI technique, can be used to evaluate the integrity of the microstructure of the white matter, even when the white matter appears normal on routine MRI.

详细描述

The aims of this study are firstly to identify DTI abnormalities in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD compared to normal controls; and secondly to determine if the location of DTI identified abnormalities correlate with the epileptogenic zone as defined using magnetoencephalography (MEG) dipole clusters. Our hypotheses are firstly DTI can demonstrate the anatomic delineation of white matter abnormalities in MRI-negative partial epilepsy and the alteration in DTI indices are similar in MRI-negative partial epilepsy and MRI-visible FCD, which is the positive control; and secondly the anatomical location of DTI identified abnormalities correlate with the epileptogenic zone as defined by MEG dipole clusters. The long-term goal of this study is to improve detection of subtle lesions in children with MRI-negative partial epilepsy so as to improve the surgical outcome of these patients who undergo epilepsy surgery for seizure control.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • MRI negative partial epilepsy group:
  • Patients diagnosed with partial epilepsy according to the International League Against Epilepsy (ILAE) standard [53]
  • MRI study reported as normal
  • Age ranging from 6-18 years (DTI indices alter with myelination and the changes are most marked from birth to 4 years of age)
  • MRI-visible FCD group:
  • Patients diagnosed with partial epilepsy according to the ILAE standard [53]
  • Visual assessment of MRI demonstrates one or more features of FCD
  • Cortical thickening
  • Alteration in sulci and gyri pattern, including deep sulci
  • Blurring of gray-white matter transition
  • T2 signal prolongation of the cortex and subcortical white matter
  • High T1 signal in the cortex
  • Age ranging from 6-18 years (DTI indices alter with myelination and the changes are most marked from birth to 4 years of age)
  • Normal controls:
  • Subjects with no history of neurological diseases
  • Age ranging from 6-18 years (most children under the age of 6 years are unable to tolerate the MR examination without general anesthesia or sedation).
  • No requirement of general anesthesia or sedation

排除标准

  • Subjects with contraindications for MR imaging (i.e. retained foreign bodies, implants)
  • Subjects with claustrophobia
  • Controls with a prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay or learning disability
  • Controls who require general anesthesia or sedation

结局指标

主要结局

Identify DTI changes in the white matter of children with MRI-negative partial epilepsy and MRI-visible FCD using voxel-by-voxel analysis of FA and MD maps compared to normal controls.

时间窗: 1 timepoint; immediately after MRI/DTI

次要结局

  • Determine if the lobar location of abnormal FA and MD correlate with the lobar location of MEG defined epileptogenic zone in MRI-negative partial epilepsy and MRI-visible FCD.(1 timepoint; immediately after MRI/DTI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elysa Widjaja

Staff Neuroradiologist

The Hospital for Sick Children

研究点 (1)

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