脑机接口技术已进入“临床价值验证与早期产业化”的关键期

Core Viewpoint - Brain-computer interface (BCI) technology is a critical area at the intersection of life sciences and information technology, with significant global competition and potential applications in medical fields, particularly in disease prevention, diagnosis, treatment, and management [1] Group 1: Current Applications and Progress - BCI technology is primarily applied in clinical settings for the rehabilitation of motor and speech functions, with motor function recovery being the most advanced area [2] - Notable examples include Neuralink's successful implantation in over ten patients and the clinical validation of products like Synchron's Stentrode and Onward Medical's ARC-BCI [2] - In speech function, the "Beijing Brain No. 1" system has made significant progress in decoding speech for patients with severe speech disorders due to conditions like ALS [2] Group 2: Technology Maturity and Challenges - The current stage of BCI technology is characterized as a critical period for clinical value verification and early industrialization, facing both unprecedented policy support and intense international competition [3] - Key evaluation metrics include safety and reliability, effectiveness and stability, and usability, with ongoing challenges in long-term safety, performance stability in real-life scenarios, and maintenance issues [4] Group 3: Technical Challenges and Breakthrough Directions - Major technical challenges include balancing high-resolution signal acquisition with low invasiveness, and developing systems that ensure low power consumption while maintaining real-time performance [5][6] - The need for "plug-and-play" capabilities in decoding algorithms and addressing individual variability and time drift are also critical areas for future breakthroughs [6] Group 4: Barriers to Large-Scale Clinical Application - Key barriers to large-scale clinical application include the need for rigorous clinical trials to establish safety and efficacy, the development of reliable manufacturing processes, and the establishment of ethical and legal frameworks [7] - Predictions suggest that semi-invasive BCIs may take 1-2 years for approval in rehabilitation applications, while invasive BCIs may require around 5 years [7] Group 5: Future Development Possibilities - Future applications of BCI technology are expected to extend beyond motor rehabilitation to include speech function restoration and treatment for severe neurological disorders, with aspirations for merging biological intelligence with artificial intelligence to enhance human capabilities [8]