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临床试验/NCT03587506
NCT03587506已完成不适用

The Relationship Between Periodic Limb Movement and Seizure Recurrence in Genetic Generalized Epilepsy

University of Alexandria0 个研究点目标入组 60 人开始时间: 2015年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Seizure recurrence

研究概览

简要总结

The study aimed to study the correlation between periodic limb movement occurring during sleep and the different parameters of genetic generalized epilepsy

详细描述

Although periodic limb movements are prevalent among patients with epilepsy, the exact relationship between these movements and epilepsy remains elusive. Objective: The aim of this work was to study the periodic limb movements among patients with genetic generalized epilepsy in relation to different clinical characteristics and seizure recurrence. Methods: Sixty individuals participated in this study: thirty of them were newly diagnosed with genetic generalized epilepsy and thirty were healthy individuals. Sleep quality was assessed using the Pittsburgh Sleep Quality Index questionnaire, and a standard polysomnographic study was conducted to all subjects. All patients then received sodium valproate in therapeutic doses and were followed up for six months. Electroencephalogram (EEG) was done after the follow-up period and seizure recurrence was assessed. Accordingly, patients were classified into three groups according to clinical seizure recurrence and follow-up EEG findings.

Periodic limb movement index and frequency were compared among the patients' groups and were correlated with different clinical characteristics.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria
  • did not previously receive AEDs.
  • The clinical seizures were either eyewitnessed by physicians or video-recorded to ensure they were true epileptic seizures.
  • At least two unprovoked seizures occurring >24 hours apart

排除标准

  • Patients with pre-existing psychiatric illnesses
  • Patients with seizures due to toxic or metabolic causes (including glucose disturbance, uremia, and electrolytes disturbance), infections, or structural causes (such as neoplasms)
  • Patients using hypnotic drugs

结局指标

主要结局

Seizure recurrence

时间窗: 6 months

Clinical major or minor seizure, and electrical seizure

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

Eman Hamdy

Assistant lecturer of Neurology

University of Alexandria

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