A Study of the Higher Cognitive Functions of the Human Brain Based on the Use of Hyperflexible Neural Electrode-cortex for Single-neuron Activity Recording
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- recording single neural spikes
研究概览
简要总结
This study aims to investigate that neural activity of higher cognitve function of human brain with hyperflexible neural electrode-cortex
详细描述
In this study, patients who need intracerebral puncture and indwelling drainage tube, such as intracerebral hemorrhage and hydrocephalus, will be recruited. Before implanting electrodes, patients will be trained to do higher cognitive function tasks.During operation, electrode will be implanted accompanied by placing drainage tube. After operation, patients will perform tasks, while electrophysiological signals will be collected. At the end of study, electrode will be removed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years old.
- •have selective or confine operation indications:spontaneous basal ganglia hemorrhage or lobar hemorrhage that need catheter aspiration and drainage;hydrocephalus that need V-P shunt; need placing ommaya.
- •GCS score 12-15; must be able to communicate with investigators in Mandarin and comply with study requirements.
- •volunteered to participate in this study and sign informed consent.
排除标准
- •have severe cognitive dysfunction.
- •have psychiatric disorders, such as depression, anxiety disorders and schizophrenia.
- •long-term use of special medications, such as hormones, immunosuppressant, and anticoagulants.
- •be allergic to surgery instruments or medications.
- •have general anesthesia, surgery contraindications.
- •have acute cardiac infarction or heart arrest within 6 months.
- •have other neurosurgery contraindications assessed by investigators.
- •lactation or pregnancy.
- •have serious systemic disease or organ dysfunctions that affects study outcome or visits.
- •participate in other ongoing clinical trials.
结局指标
主要结局
recording single neural spikes
时间窗: through study completion, an average of 2 year
The mechanism of higher cognitive functions will be investigated by analysing characteristics of single neural spikes which is correlated with higher cognitive functions tasks, such as firing frequency, events related potential, information coding, etc.
recording local field potentiation
时间窗: through study completion, an average of 2 year
The mechanism of higher cognitive functions will be investigated by analysing characteristics of local field potentiation which is correlated with higher cognitive functions tasks, such as events related potential, information coding, etc.
次要结局
未报告次要终点
研究者
Xuehai Wu
Professor, Huashan Hospital
Huashan Hospital