Microelectrode Brain-Machine Interface for Individuals With Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Participants With Successful Implant
研究概览
简要总结
The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.
详细描述
Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of use of the arms and legs) have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural signals are generated even though they are not sent to the arms, hands and legs. By implanting electrodes in the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Limited or no ability to use both hands due to cervical spinal cord injury or brainstem or spinal stroke
- •At least 1 year post-injury
- •Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training
- •Additional inclusion criteria must also be reviewed
排除标准
- •Certain implanted devices
- •Presence of other serious disease or disorder that could affect ability to participate in this study
- •Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise
- •Additional exclusion criteria must also be reviewed
结局指标
主要结局
Number of Participants With Successful Implant
时间窗: One year following array implantation
Number of participants who were implanted for at least one year without having to explant the device for safety reasons.
次要结局
- 7 Degree-of-freedom Movement by Neural Control(One year following array implantation)
- 10 Degree-of-freedom Movement by Neural Control(One year following array implantation)
研究者
Michael Boninger
Vice Chair of Research
University of Pittsburgh