Stable and Independent Non-invasive Communication Brain-computer Interfaces Based on Error-adaptive Decoding Algorithms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Brain-computer interface stability
研究概览
简要总结
People with locked-in syndrome cannot move their limbs or talk because of a motor impairment, but remain conscious and intellectually awake. Restoring the ability to communicate to people with locked-in syndrome will have a positive effect on their quality of life, will enable them to reintegrate into society and increase their capacity to lead productive and fulfilling lives. This study sims to develop a new assisted communication device based on a brain-computer interface, a system that allows the user to control a computer with his brain activity. The investigators will develop this brain-computer system for long-term stability and independent use by using adaptive decoders. The investigators will test the long-term stability and independence of this system with healthy volunteers, people with tetraplegia and people with locked-in syndrome over time periods of several months.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- 是
入选标准
- •for healthy persons:
- •Older than 18
- •Fluent in French, English, German or Italian
- •Good visual acuity
- •Inclusion criteria for people with tetraplegia:
- •Older than 18
- •Fluent in French, English, German or Italian
- •Good visual acuity
- •Diagnosed with spinal cord injury, brainstem stroke, spinal stroke, muscular dystrophy or other non-degenerative motor neuron disorders
- •Limited or no ability to use both hands - less than grade 4 muscle strength in elbow extension and wrist extension and less than grade 2 strength in finger flexor and abduction on both sides
- •Inclusion criteria for people with locked-in syndrome:
- •Were fluent in French, English, German or Italian before losing the ability to speak
- •Enough visual capability to see large letters from a distance of around 50cm according to caretaker's or guardian's opinion
排除标准
- •for healthy persons:
- •Substance or alcohol abuse
- •Neurological or psychiatric illness
- •History of cranio-facial surgery
- •Metallic implants that would prohibit the subject from having a MRI scan
- •Medications that may retard motor coordination and cognitive ability (such as sedatives)
- •Seizure disorders
- •Treated with anti-epileptic medications
- •Exclusion criteria for people with tetraplegia and locked-in syndrome:
- •Disabling neurological illness other than tetraplegia or locked-in syndrome
- •Disabling psychiatric illness
- •History of cranio-facial surgery
结局指标
主要结局
Brain-computer interface stability
时间窗: 3 years
The investigators will measure the text-entry rate achieved using the brain-computer interface in each session by the number of correct characters per minute (CCPM). At the end of the study, the investigators will calculate the average brain-computer interface performance, and the correlation between the performance and the duration of brain-computer interface use (performance-use correlation). Brain-computer interface stability will be established if the performance-use correlation is greater than -0.5 CCPM/year. Primary objective of the study will be met if the brain-computer interface performance is stable for 75% of participants or more in each of three study populations, and if the average brain-computer interface performance for participants that show stable performance is greater than 5 CCPM.
次要结局
- Brain-computer interface performance comparison(3 years)
研究者
Tomislav Milekovic
Principal Investigator
University of Geneva, Switzerland