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临床试验/NCT03551431
NCT03551431Unknown不适用

Comparison of Efficacy Between Suggestion Method During Video EEG Recording by Verbal Suggestion in Isolation and Verbal Suggestion Along With Cotton Swab or Tuning Fork for Inducing the Paroxysmal Event in Children Aged 5 to 18 Years With Suspected Psychogenic Nonepileptic Events

All India Institute of Medical Sciences, New Delhi0 个研究点目标入组 25 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
25
主要终点
Percentage of children in each group, in whom the paroxysmal event could be reproduced by suggestion

研究概览

简要总结

In this study we are going to compare efficacy between suggestion method during video EEG recording by verbal suggestion in isolation and verbal suggestion along with cotton swab or tuning fork for inducing the paroxysmal event in children aged 5 to 18 years with suspected psychogenic nonepileptic events. Still there is paucity of data regarding the optimum method for video EEG by suggestion for psychogenic nonepileptic events. We are planning to recruit 25 children aged 5 to 18 years in each of the three arms after taking informed consent from the guardian and then they will be subjected to video EEG by any one of the three suggestion methods.

研究设计

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

入排标准

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

入选标准

  • •Children between 5 and 18 years of age with suspected diagnosis of psychogenic nonepileptic events -

排除标准

  • •Children with paroxysmal events, who will be later diagnosed as having epilepsy or movement disorder

研究组 & 干预措施

video EEG with verbal suggestion and cotton swab

Experimental

干预措施: Video EEG with verbal suggestion (Diagnostic Test)

Video EEG with verbal suggestion

Experimental

干预措施: Video EEG with verbal suggestion (Diagnostic Test)

video EEG with verbal suggestion and tuning fork

Experimental

干预措施: Video EEG with verbal suggestion (Diagnostic Test)

结局指标

主要结局

Percentage of children in each group, in whom the paroxysmal event could be reproduced by suggestion

时间窗: 30 minutes

Percentage of children in each group, in whom the paroxysmal event could be induced by suggestion

次要结局

未报告次要终点

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheffali Gulati

Professor and Chief, Child Neurology Division, Department of Pediatrics, AIIMS, New Delhi

All India Institute of Medical Sciences, New Delhi

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