新突破！我国侵入式脑机接口进入临床试验阶段

Core Viewpoint - The article highlights the successful initiation of China's first invasive brain-computer interface (BCI) clinical trial, marking a significant advancement in the field and positioning China as the second country globally to enter this phase after the United States [1]. Group 1: Clinical Trial and Patient Outcomes - The clinical trial involves a male subject who lost all four limbs due to an electric shock accident. Since the implantation of the BCI device in March 2025, the system has operated stably without infections or electrode failures for over a month. 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]. - The BCI system is expected to significantly improve the quality of life for patients with complete spinal cord injuries, double upper limb amputations, and amyotrophic lateral sclerosis once it receives approval for registration and market launch [1]. Group 2: Technological Advancements - The BCI system developed by the research teams is noted for having the smallest and most flexible neural electrodes globally, with a cross-sectional area only 1/5 to 1/7 that of Neuralink's electrodes. This design minimizes damage to brain tissue and enhances compatibility with neural interfaces [2]. - The system is the only one in China to have received a registration-type inspection report and can stably collect single-neuron spike signals, providing a solid data foundation for applications [3]. Group 3: Surgical and Operational Efficiency - The implanted device has a diameter of 26mm and a thickness of less than 6mm, making it the smallest brain-controlled implant globally, only half the size of Neuralink's product. This allows for a less invasive surgical procedure, reducing risks and recovery time [3]. - The design of the BCI system is based on principles of neuroscience, allowing for similar control levels to Neuralink with fewer implanted electrodes, thus minimizing patient risk [4]. Group 4: Future Applications - Following successful trials in non-human primates, the project team aims to enable the subject to control a robotic arm for physical tasks such as grasping and holding objects. Future developments may include controlling complex physical devices like robotic dogs and intelligent agents, thereby expanding the subject's capabilities in daily life [4].