脑智卓越中心研制的植入体。 受访者供图 临床试验手术现场。 近期，我国首例侵入式脑机接口的前瞻性临床试验成功开展。这标志着中国在侵入式脑机接口技术上成 为继美国之后，全球第二个进入临床试验阶段的国家。 该项研究由中国科学院脑科学与智能技术卓越创新中心，联合复旦大学附属华山医院以及相关企业合作 开展。 实时的"脑语言翻译器" 据中国科学院脑科学与智能技术卓越创新中心研究员赵郑拓介绍，临床试验受试者的背景、选择标准和 术前准备经过了严格的科学和伦理考量。 "受试者是完全性脊髓损伤或双上肢截肢患者。在选择受试者时，我们会看他的运动功能障碍程度，优 先考虑能通过脑机接口显著改善生存质量的患者，还考量受试者有无其他严重疾病、大脑运动皮层是否 研发团队通过动物试验到人体试验的递进，确保了技术的成熟度、安全性和功能有效性，最终实现从实 验室到临床的突破。 一名因高压电事故失去四肢的男性，在一场手术后，用脑海中的意念下象棋、玩赛车游戏，和普通人操 作电脑触摸板的速度相差无几。 这不是科幻小说，而是近期真实发生在中国的医学突破。 时间拨回到3年前。2022年，中国科学院脑科学与智能技术卓越创新中心研究团队启动了脑机接口系统 的 ...

近日，我国首例侵入式脑机接口的前瞻性临床试验成功开展，标志着中国在侵入式脑机接口技术上，成 为继美国之后全球第二个进入临床试验阶段的国家。 赵郑拓说，他们研发的神经电极横截面积小、柔性大，降低了对脑组织的损伤。该超柔性神经电极具备 高密度、大范围、高通量、长时间稳定在体内采集神经信号的能力。 这项成果也实现了"手术友好"，该中心研制的植入体直径26毫米、厚度不到6毫米。路俊锋说，只需要 在大脑运动皮层上方的颅骨上"打薄"出一块硬币大小的凹槽用以镶嵌设备，再在凹槽中打一个5毫米的 穿刺孔，用钨针将两根像轻薄丝带一样的超柔性神经电极从穿刺孔"埋入"脑组织中，相当于神经外科的 微创手术，整个植入过程耗时20—30分钟。 精准定位和植入是整个手术成功的关键。在为受试者进行手术前，路俊锋团队采用了功能磁共振成像联 合CT影像技术，重构了受试者专属三维模型与人脑运动皮层的详细功能地图，以确保植入位置的精确 性。手术当天，路俊锋团队借助高精度导航系统，在唤醒手术下将超柔性神经电极植入受试者大脑的运 动皮层指定区域，整个手术过程精确到毫米级别，最大限度地保证了安全性和有效性。 该临床试验的受试者是一名因高压电事故导致四肢截肢 ...

受试者是一位因高压电事故导致四肢截肢的男性。今年3月，两根仅有头发丝百分之一粗细的柔性电极 通过微创手术埋入了他的大脑皮层，连接到一枚硬币大小、镶嵌于颅骨的植入体上。通过这个系统，采 集到的大脑信号会以无线的方式传输给外部设备，并解码成计算机能够理解的操作意图。 脑机接口这一曾经出现在科幻电影中的"意念控制术"，如今正从梦想照进现实。记者从中国科学院获 悉：近日，中国科学院脑科学与智能技术卓越创新中心联合复旦大学附属华山医院及相关企业，成功开 展了我国首例侵入式脑机接口的前瞻性临床试验。该成果标志着我国成为继美国之后，全球第二个将侵 入式脑机接口技术推进到临床试验阶段的国家。 不仅仅是"傻大粗"的问题，以往硬质材料的电极植入后，还可能对脑组织造成损伤。赵郑拓介绍，瞄准 这些痛点，团队研制及生产的神经电极，让脑细胞几乎"意识"不到旁边有异物，可有效降低对脑组织的 损伤。而且，它还具备高密度、大范围、高通量、长时间的信号采集能力。目前，该超柔性神经电极已 相继完成在啮齿类、非人灵长类和人脑中长期植入与稳定记录验证，这为植入式脑机接口前端电极组织 相容性差和信道带宽窄等问题提供了更好的解决方案。 精准定位和植入也是 ...

近日，中国科学院脑科学与智能技术卓越创新中心联合复旦大学附属华山医院，与相关企业合 作，成功开展了我国首例侵入式脑机接口的前瞻性临床试验。该成果标志着 我国在侵入式脑 机接口技术上成为全球第二个进入临床试验阶段的国家。 受试者是一位因高压电事故导致四肢截肢的男性。自2025年3月植入该脑机接口设备以来，系 统运行稳定， 仅用2—3周的训练，他便实现了下象棋、玩赛车游戏等功能，达到了跟普通人 控制电脑触摸板相近的水平。 未来，这一系统将有望为脊髓损伤、截肢等患者群体，通过运 动功能替代技术实现生存质量改善。 全球最小尺寸、柔性最强的神经电极 △超柔性电极尺寸极小，仅约头发丝的1/100 △植入体直径26mm、厚度不到6mm，是全球最小尺寸的脑控植入体，仅硬币大小 在手术友好程度方面，脑智卓越中心研制的植入体直径26mm、厚度不到6mm， 是全球最小 尺寸的脑控植入体， 仅硬币大小，为Neuralink产品1/2。因此不需要整体贯穿颅骨，只需要 在大脑运动皮层上方的颅骨上"打薄"出一块硬币大小的凹槽用以镶嵌设备，再在凹槽中打一个 在颅骨上开5毫米的穿刺孔。采用神经外科微创术式，在有效降低手术期风险的同时，显著缩 ...

Core Insights - The article highlights the successful initiation of China's first invasive brain-computer interface (BCI) clinical trial, marking a significant advancement in the field, making China the second country after the United States to enter this phase [1] Group 1: Clinical Trial Details - The clinical trial was conducted by the Chinese Academy of Sciences' Brain Science and Intelligent Technology Center in collaboration with Fudan University Huashan Hospital, focusing on a male subject who lost all four limbs due to an electrical accident [1] - The implanted BCI device has shown stable operation since its implantation in March 2025, with no infections or electrode failures reported over a month [1] - The subject achieved functionalities such as playing chess and racing games within 2-3 weeks of training, demonstrating control comparable to that of a typical user with a computer touchpad [1] Group 2: Technological Advancements - The BCI system developed by the Zhao Zhengtuo and Li Xue teams features the world's smallest and most flexible neural electrodes, with a cross-sectional area only 1/5 to 1/7 that of Neuralink's electrodes, and flexibility exceeding Neuralink's by a factor of 100 [2] - This ultra-flexible electrode allows for high-density, large-area, and long-term stable neural signal acquisition, addressing key challenges in tissue compatibility and bandwidth limitations for implanted BCIs [2] Group 3: Surgical and Operational Efficiency - The BCI system is the only one in China with a registered report that can stably capture single-neuron spike signals, providing a solid data foundation for applications [3] - The device's dimensions are 26mm in diameter and less than 6mm in thickness, making it the smallest brain-controlled implant globally, requiring only a small recess in the skull for implantation, thus reducing surgical risks and recovery time [3] - The standardized operational procedures based on mature surgical techniques facilitate scalable applications in various medical institutions [3] Group 4: Future Applications - The BCI system is designed to achieve similar control levels as Neuralink with fewer implanted electrodes, minimizing patient risk while maximizing benefits [5] - Prior to human trials, the system's safety and functionality were validated in non-human primates, where it successfully controlled computer cursor movement through neural activity [5] - Future plans include enabling the subject to control robotic arms for physical tasks, expanding the potential for interaction with complex devices like robotic dogs and intelligent agents [5]

近日，我国首例侵入式脑机接口的前瞻性临床试验成功开展，标志着中国在侵入式脑机接口技术上成为继美国之后，全球第二个进入临床试验阶段的国 家。 该项研究由中国科学院脑科学与智能技术卓越创新中心赵郑拓研究组、李雪研究组，联合复旦大学附属华山医院吴劲松、路俊锋团队，以及相关企业合作开展，是 上海市脑机接口临床试验与转化重点实验室2024年12月成立以来的首项重要成果。 据项目团队介绍，该临床试验的受试者是一位因高压电事故导致四肢截肢的37岁男性。自今年3月受试者的大脑植入该脑机接口设备以来，系统运行稳定，术后至 今一个多月未出现感染和电极失效的情况。仅用2—3周的适应性训练，受试者便可以通过意念控制触摸板在电脑上下象棋、玩赛车游戏等，达到了跟普通人控制电 脑触摸板相近的水平。"受试者可以像正常人一样打字、发短信、玩电脑游戏"。 "我们中心组建了脑结构技术与临床应用'十四五'攻关团队，成立了覆盖从运动感知、神经功能修复、解码算法、无线系统研发等多个方向的独立研究组。"赵郑拓 介绍，攻关团队以建制化方式在脑机接口方面的研究自2022年启动，在中国科学院脑科学与智能技术卓越创新中心长达十几年在脑科学研究的积累上，上海在跨科 ...

Core Insights - The article highlights the significant progress in brain-machine interface (BMI) technology, particularly focusing on China's first invasive BMI clinical trial, marking a milestone in the medical application of this technology [1][2][11] - The Chinese research team has developed the world's smallest and most flexible neural electrodes, which are now in clinical trials, positioning China as the second country after the United States to enter this phase [1][5] Group 1: Clinical Trial Details - The invasive BMI clinical trial was successfully conducted by a collaboration between the Chinese Academy of Sciences and Fudan University, with the first subject being a male patient who lost his limbs due to an electrical accident [2][11] - The system has shown stable operation since its implantation in March 2025, with no infections or electrode failures reported, allowing the patient to perform tasks like playing chess and racing games within 2 to 3 weeks of training [4][10] Group 2: Technological Advancements - The neural electrodes developed by the Chinese team have a cross-sectional area that is 1/5 to 1/7 of those used by Neuralink, with flexibility exceeding Neuralink's by over 100 times, minimizing damage to brain tissue [5][8] - The implanted BMI system is capable of long-term stable collection of single-neuron spike signals, providing a solid data foundation for applications in neuroprosthetics [5][7] Group 3: Surgical and Operational Innovations - The BMI system features a compact design with a diameter of 26mm and a thickness of less than 6mm, allowing for a minimally invasive surgical procedure that reduces risks and recovery time [7][11] - The surgical procedure utilized advanced imaging techniques to create a detailed 3D model of the patient's brain, ensuring precise electrode placement [11][13] Group 4: Future Applications and Research Directions - The research team aims to expand the functionality of the BMI system to enable patients to control robotic arms and other external devices, enhancing their quality of life [11][12] - Future developments may incorporate machine learning and artificial intelligence to interpret more complex signals, potentially allowing for communication through thought [11][12]