脑机接口技术正加速从实验室进入临床阶段，国内已开发出非侵入式、半侵入式和侵入式三种技术路径的产品1。其中，半侵入式脑机接口"北脑一号"已取得突破进展，植入一年后使脊髓损伤患者从完全瘫痪恢复至不完全性损伤，实现支具辅助下独立行走1。北京脑科学与类脑研究所所长罗敏敏表示，"2025年3月，'北脑一号'启动了多中心注册临床试验"1，并"计划2027年申报医疗器械注册证"1。
侵入式脑机接口的临床推进步伐同样快速1。北京智冉医疗今年5月启动国内首个超百通道侵入式脑机接口系统注册临床试验，采用128通道脑机接口系统，临床试验预计2027年完成1。与此同时，采用512通道无线全植入柔性皮层内电极阵列的"北脑二号"正计划年内启动人体临床验证1。
在产业化方面，"脑机海河实验室"已开发出30多项"神工"医疗器械谱系产品，造福患者数千人1。为培养该领域人才，天津大学在国内率先设立了"脑机科学与技术"本科专业1。专家认为脑机接口未来5至10年内有望实现更多功能重建和神经调控应用，但其有效性、安全性仍需时间验证1。
Brain-computer interface technology is rapidly transitioning from laboratory research to clinical practice in China, with developers advancing three distinct technological pathways including non-invasive, semi-invasive, and invasive systems 1. Among these, the semi-invasive "Brain One" interface has enabled a spinal cord injury patient to regain the ability to walk independently with orthotic support after one year of implantation, progressing from complete paralysis to incomplete spinal cord injury status 1.
The trajectory of clinical advancement is becoming increasingly clear. In March 2025, "Brain One" initiated multi-center registration clinical trials, with plans to apply for medical device registration certification by 2027, according to Min Luo, director of the Beijing Institute of Brain Science and Brain-like Intelligence 1. Meanwhile, Beijing Zhiran Medical launched China's first super-hundred-channel invasive brain-computer interface system registration clinical trial in May this year, utilizing a 128-channel system expected to complete by 2027 1. The "Brain One" successor, "Brain Two," employs a 512-channel wireless fully implanted flexible cortical electrode array and is scheduled to initiate human clinical validation within the year 1.
The broader ecosystem is developing rapidly to support these advances. The "Brain-Computer Integrated Harbor Laboratory" has already developed over 30 medical device products in its "Divine Craft" product line, benefiting thousands of patients 1. Additionally, Tianjin University has established China's first undergraduate major in "Brain-Computer Science and Technology" 1. Experts indicate that brain-computer interfaces may achieve additional functional reconstruction and neuromodulation applications within the next 5 to 10 years, though validation of efficacy and safety remains essential 1.
评论
还没有评论，欢迎留下第一条。