BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- 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 aphasia to generate text on a computer screen and audible, computer-generated speech by attempting to speak.
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 or aphasia, 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
- Device Feasibility
- 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 expressive aphasia due to ischemic or hemorrhagic stroke (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 Neural Interface System
Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex. Up to six 4x4 mm NeuroPort or MultiPort sensor(s) are placed into the speech or language areas of cortex, connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
干预措施: BrainGate Neural Interface System (Device)
结局指标
主要结局
Safety of the BrainGate2 Neural Interface System
时间窗: One year post-implant evaluation period
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System
次要结局
- Feasibility of speech decoding(One-year post implant evaluation period)
研究者
Leigh R. Hochberg, MD, PhD.
Sponsor-Investigator
Massachusetts General Hospital