Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Wilcoxon statistic (Area Under the Curve)
研究概览
简要总结
The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).
详细描述
Brain Computer Interface (BCI) are used to restore control and communication in patient with severe disabilities such as Locked In Syndrome (LIS) patients.
The aim of this study is to identify the most relevant recording technique for extraction of P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by principal investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers male or female aging over 18
- •Signed informed consent
- •Passed the preliminary exam
- •Registered in the national database for persons willing to participate in Biomedical research
排除标准
- •Visual or hearing problems
- •Cognitive problems
- •Illiterate persons
- •Persons under Guardianship or Trusteeship
- •Having Epilepsy
- •Pregnant women Not covered by the social security system
结局指标
主要结局
Wilcoxon statistic (Area Under the Curve)
时间窗: T0+2h (end of each technique)
An Linear Discriminant Analysis (LDA) will be used to discriminate target and Algorithm performance (Wilcoxon statistic) for discrimination between occurrent and non-occurrent stimuli. Signals will adequately be pre-processed: denoised and spatialy filtered (xDAWN). The Area Under the Receiver Operator Characteristic Curve (AUC) also called wilcoxon statistic will be used to identify the signals of best quality.
次要结局
未报告次要终点