Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
研究概览
简要总结
The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.
详细描述
The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Between 18 and 80 years of age
- •Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
- •Complete or incomplete tetraplegia (quadriplegia)
- •Must live within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
- •(There are additional inclusion criteria)
排除标准
- •Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
- •Chronic oral or intravenous steroids or immunosuppressive therapy
- •Other serious disease or disorder that could seriously affect ability to participate in the study
- •(There are additional exclusion criteria)
结局指标
主要结局
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
时间窗: 1 year
To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.
次要结局
- Decoded speech output accuracy(At participant exit from study, or up to 5 years)
研究者
Leigh R. Hochberg, MD, PhD.
Neurologist
Massachusetts General Hospital