跳至主要内容
临床试验/NCT05530109
NCT05530109终止不适用

Study of Attentional Disorders in Patients Suffering From Idiopathic Generalized Epilepsy.

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2022年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
33
试验地点
1
主要终点
Epitrack scale score

研究概览

简要总结

Attentional disorders have been reported in neuropsychological studies evaluating patients suffering from generalized idiopathic epilepsy, but the data are disparate (in terms of test protocol). We aim to describe attentional and executive function disorder in IGE thanks to the Epitrack scale, validated in this specific population. Our secondary objective is to study the dynamic of cortical activity during an attentional task (the ANT), in order to describe the alteration of cortical networks in epileptic patients presenting with attentional disturbance.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic generalized epilepsy followed-up during at least 2 years
  • At least one antiepileptic drug medication
  • No cognitive decline (MoCA score >26)
  • Absence of concomitant pathology that could interfere with the purpose of the study.
  • Be affiliated to the social security system
  • Have signed an informed consent

排除标准

  • Pregnancy
  • Not able to give consent (Article 1121-8 of the CSP) Vulnerable person Being deprived of liberty by judicial or administrative decision (Article L 1121-6 of the CSP) Have a high probability of not respecting the protocol or of abandoning the study

结局指标

主要结局

Epitrack scale score

时间窗: At 1 month after inclusion

EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. scale from 9-49 (9 worst score - 49 best score)

次要结局

  • D2-R test score(At 1 month after inclusion)
  • STAI scale(At 1 month after inclusion)
  • Raven's progressive matrice scores(At 1 month after inclusion)
  • Montreal Cognitive Assessment (MoCA) score(At 1 month after inclusion)
  • quality of life using the Qolie-31 self questionnaire(At 1 month after inclusion)
  • BDI-II score(At 1 month after inclusion)
  • High resolution Electro Encephalo Gram functional connectivity markers at rest and during the ANT task(At 1 month after inclusion)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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