Intuitive, Complete Neural Control of Tablet Computers for Communication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 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
People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.
详细描述
The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).
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 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
- •Prior enrollment in BrainGate2 clinical trial (NCT00912041)
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: BrainGate Neural Interface System
干预措施: BrainGate Neural Interface System (Device)
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
未报告次要终点
研究者
Leigh R. Hochberg, MD, PhD.
Neurologist
Massachusetts General Hospital