EEG@HOME (Phase 4 of the Project)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- EEG signal quality (visual and clinical) (scale)
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.
In this stage of the project video-EEG recording with the prototype will be compared to the conventional way (cup-electrodes and collodion) of recording in the EMU.
Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional recording is completed, the patient will undergo a recording of maximum 5 hours with the prototype.
There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience and experience of the EEG-technologists 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
- 4 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epilepsy with on EEG prominent IEDs
排除标准
- 未提供
研究组 & 干预措施
conventional video-EEG monitoring
conventional video-EEG monitoring with cup-electrodes and collodion
干预措施: video-EEG monitoring (Other)
video-EEG monitoring with prototype
video-EEG monitoring of 5 hours with EEG-cap with dry electrodes
干预措施: video-EEG monitoring (Other)
结局指标
主要结局
EEG signal quality (visual and clinical) (scale)
时间窗: 5 hours
EEG signal quality (technical) (signal to noise ratio)
时间窗: 5 hours
User experience (questionnaire)
时间窗: 5 hours
次要结局
- EEG-technologist experience (questionnaire)(5 hours)
研究者
Neurologie
Prof. dr. Kristl Vonck
University Hospital, Ghent