EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 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 Phase 2 of the project will comprise of an EEG-registration with the different types of electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations, for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP measurement with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-registration will take between 5 and 10 minutes.
Minimum 2 - maximum 10 healthy volunteers 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
- 是
入选标准
- •Healthy volunteers
排除标准
- 未提供
研究组 & 干预措施
conventional EEG-registration type 1
conventional EEG-registration with wet bridge electrodes and conductive gel
干预措施: EEG (Device)
conventional EEG-registration type 2
conventional EEG-registration with wet cup electrodes and collodion
干预措施: EEG (Device)
EEG-registration with dry electrodes
EEG-registration with dry electrodes
干预措施: EEG (Device)
结局指标
主要结局
EEG signal quality (visual and clinical) (scale)
时间窗: 10 minutes
EEG signal quality (technical) (signal to noise ratio)
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
Neurologie
Prof. dr. Kristl Vonck
University Hospital, Ghent
