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临床试验/NCT03643471
NCT03643471Unknown不适用

Role of Advanced Magnetic Resonance Imaging in Diagnosis of Idiopathic Temporal Lobe Epilepsy

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Calculating the sensitivity,specificity and accuracy of hippocampal volumetry , T2 relaxometry , MR spectroscopy and diffusion tensor imaging in identification and lataeralization of epileptogenic focus

研究概览

简要总结

We aim to o evaluate the role of conventional and advanced MRI sequences in diagnosis of idiopathic temporal lobe epilepsy including identification and lateralization of epileptogenic focus.

详细描述

Patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study MRI study will be done for each patient. MR imaging will be performed on a 1.5-T MR imaging unit (Siemens, Sembra medical system,German).

Prospectively completed data forms will be analyzed and compared. Statistical tests appropriate to the nature of the data will be used.

All patients will not be subjected to risk of any kind during this study. All patients' data will be confidentially kept. Approval of the ethical committee of Faculty of Medicine, Assiut University.

An informed consent will be taken from all patients included in this study. The research will be conducted only by scientifically qualified and trained personnel.

The procedures included in this study have been already used in hospital and centers in and outside Egypt

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study based on the following criteria:
  • Clinical features consistent with seizures of temporal lobe origin.
  • Focal ictal temporal lobe patterns recorded with EEG.
  • No lesion detected by conventional MR imaging other than mesial temporal sclerosis.

排除标准

  • Any general contraindication of MRI in some cases as presence of para magnetic substance as pacemakers or in patients with claustrophobia.
  • Subjects with age less than 12 year old.
  • Patients with any structural lesion other than mesial temporal sclerosis identified on MR brain imaging.

结局指标

主要结局

Calculating the sensitivity,specificity and accuracy of hippocampal volumetry , T2 relaxometry , MR spectroscopy and diffusion tensor imaging in identification and lataeralization of epileptogenic focus

时间窗: baseline

* Quantification of hippocampal volumes bilaterally by mean of hippocampal volumetry * Change in metabolites ratio at the affected hippocampus by mean of MR spectroscopy

次要结局

未报告次要终点

研究者

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

Radwa Anas Abou El-Kasem

Assistant lecturer

Assiut University

研究点 (1)

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