NCT01897818Unknown不适用
Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the full achievement of "copy spelling" and "free spelling" tests session 1
研究概览
简要总结
ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18
- •have a diagnosis of ALS suspected, possible, probable with EMG
- •be able to follow the study process and to comply with the schedule of visits upon entry into the study
- •understand the purpose of the study
- •expressing P300 wave in the conditions of the study
排除标准
- •have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study
- •have a significant history of photosensitive epilepsy
- •have a history of allergy to the gel used for the electrodes
- •Major protected by law (guardianship, curators)
- •have uncorrectable visual disorders
- •not being able to maintain a sitting position and focus on a computer screen for more than 30 min.
研究组 & 干预措施
ALS patients
Experimental
干预措施: communication system P300 Speller (Device)
结局指标
主要结局
the full achievement of "copy spelling" and "free spelling" tests session 1
时间窗: 14 days after inclusion
the full achievement of "copy spelling" and "free spelling" tests session 2
时间窗: 28 days after inclusion
次要结局
未报告次要终点
研究者
研究点 (1)
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