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临床试验/NCT02408627
NCT02408627已完成不适用

EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
1
主要终点
EEG signal quality (technical) (signal to noise ratio)

研究概览

简要总结

The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.

Phase 3a of the project will comprise of an EEG-registration with the different types of electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-recording will take approximately 10 minutes.

Minimum 2 - maximum 10 epilepsy patients will be included.

There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience will also be collected.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG

排除标准

  • •Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG

研究组 & 干预措施

conventional EEG-registration type 1

Active Comparator

conventional EEG-registration with wet bridge electrodes and conductive gel

干预措施: EEG (Device)

conventional EEG-registration type 2

Active Comparator

conventional EEG-registration with wet cup electrodes and collodion

干预措施: EEG (Device)

EEG-registration with dry electrodes

Experimental

EEG-registration with dry electrodes

干预措施: EEG (Device)

结局指标

主要结局

EEG signal quality (technical) (signal to noise ratio)

时间窗: 10 minutes

EEG signal quality (visual and clinical) (scale)

时间窗: 10 minutes

User experience (questionnaire)

时间窗: 10 minutes

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

Neurologie

Prof. dr. Kristl Vonck

University Hospital, Ghent

研究点 (1)

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