BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 11
- 主要终点
- The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.
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
- •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
- •(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)
研究组 & 干预措施
BrainGate
BrainGate Neural Interface System
干预措施: Placement of the BrainGate2 sensor(s) into the motor-related cortex (Device)
结局指标
主要结局
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.
时间窗: One year post-implant evaluation period
次要结局
- To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.(Course of the study)
研究者
Leigh R. Hochberg, MD, PhD.
Sponsor-Investigator
Massachusetts General Hospital