A Prospective Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Recording System (WRS) for General Control of External Devices in Paralyzed/Amputee Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Device-Related Adverse Events (AE)
研究概览
简要总结
The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.
WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.
详细描述
The investigators' technology is designed to assist paralyzed and amputee patients in regaining certain physical functions, thereby improving participants' overall quality of life and daily convenience.
The investigators hope to enable participants to achieve general control over external devices through neural signals in this clinical trial. This eliminates the need for manual manipulation to control devices such as a cursor or other assistive technologies, which can be operated solely through thought. Such advancements will facilitate enhanced communication with loved ones, support the acquisition of new skills, and provide more accessible opportunities for entertainment.
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 18-80 years (inclusive), any gender.
- •Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.
- •Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.
- •Willing to follow the study protocol and attend all visits, with or without caregiver assistance.
- •Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.
排除标准
- •Previous implantation of metal objects or devices (except dental implants or non-impacting implants).
- •Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
- •Unable to tolerate anesthesia or surgery.
- •Severe neurological disorders or brain injury leading to significant dysfunction.
- •Scalp conditions that may impair wound healing.
- •Acute or severe infections.
- •Cognitive impairment or psychiatric disorders.
- •Severe dysfunction of vital organs, malignancies, or autoimmune diseases.
- •Life expectancy under 1 year.
- •Drug or alcohol abuse.
- •Pregnant, breastfeeding, or planning pregnancy during the study.
- •Other conditions deemed unsuitable by the investigator.
结局指标
主要结局
Device-Related Adverse Events (AE)
时间窗: Through study completion, an average of 7 months
次要结局
- Adverse Events(Through study completion, an average of 7 months)
- Serious Adverse Event(Through study completion, an average of 7 months)
- BPS(At an average of 4 to 7 months after implantation, both before and during the follow-up phases.)
- Usage Time (hours/month)(At an average of 5 to 7 months after implantation, during the follow-up phases.)
- Accuracy(At an average of 5 to 7 months after implantation, during the follow-up phases.)
- Psychological State(At an average of 4 to 7 months after implantation, both before and during the follow-up phases.)
- Caregiver Burden(At an average of 4 to 7 months after implantation, both before and during the follow-up phases.)