A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Adverse Events
研究概览
简要总结
Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.
详细描述
To evaluate the safety and efficacy of an implantable neural acquisitor & stimulator system in patients with motor disability（Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders).
Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.
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
- •Aged between 18 and 80 years of age;
- •Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;
- •After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；
- •The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；
- •The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.
排除标准
- •Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；
- •Combined with progressive neurological disease；
- •Combined with surgical contraindications identified by surgeons and anesthesiologists;
- •Participating in other clinical trials;
- •Other conditions deemed inappropriate by investigators and medical staff.
结局指标
主要结局
Adverse Events
时间窗: 12 months after implantation
Number of Participants With the device-Related Adverse Events
次要结局
- BCI performance by bit rate(3, 6, 12 months after implantation)
- Hours use of the implantable neural acquisitor & stimulator (NEO) per month(3, 6, 12 months after implantation)
- BCI performance classification accuracy(3, 6, 12 months after implantation)
- Patient/caregiver satisfaction(3, 6, 12 months after implantation)