Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Device Safety
研究概览
简要总结
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
详细描述
The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.
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.
- •Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
- •Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
- •Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
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)
研究组 & 干预措施
BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex
干预措施: BrainGate Neural Interface System (Device)
结局指标
主要结局
Device Safety
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
- Device Feasibility(At participant exit from study, or up to 5 years)
研究者
Leigh R. Hochberg, MD, PhD.
Neurologist
Massachusetts General Hospital