AI 中文总结
该研究对中国脑机接口转化生态系统进行定量分析，整合研究者发起试验、注册临床试验和监管批准产品三方面证据，发现临床注册自2020年迅速增加，非侵入性系统为主，已批准5种相关产品，不过仍有障碍，应对挑战对BCI临床应用至关重要。
AI 中文摘要
神经损伤影响全球数亿人，现有疗法难以逆转中风、脊髓损伤和神经退行性疾病导致的运动或沟通功能丧失。脑机接口（BCI）有望通过将神经活动解码为控制外部设备的命令来恢复这些功能。本文首次对中国BCI转化生态系统进行定量分析，整合了研究者发起试验、注册临床试验和监管批准产品三方面的证据。分析了中国临床试验注册中心的134项临床试验、26项研究者发起试验以及截至2026年6月国家药品监督管理局批准的5种BCI相关产品。结果表明，自2020年以来临床试验注册迅速增加，研究中心主要集中在广东、上海和江苏。非侵入性系统占主导，中风康复是主要适应症。截至2026年6月，5种BCI相关产品获得监管批准。这些发现表明中国BCI转化渠道迅速扩大，但长期植入稳定性、临床基础设施和工作流程的标准化以及解码算法的通用性仍是广泛临床应用的关键障碍。应对这些挑战对于将BCI技术整合到常规临床实践至关重要。
英文摘要
Neurological injury affects hundreds of millions of people worldwide, yet the loss of motor or communication functions resulting from stroke, spinal cord injury, and neurodegenerative disease remains largely irreversible with existing therapies. Brain-computer interfaces (BCIs) offer a promising pathway for restoring these functions by decoding neural activity into commands that control an external device. Here, we present the first quantitative analysis of China's BCI translational ecosystem, integrating evidence from three pillars: investigator-initiated trials (IITs), registered clinical trials, and regulatory-approved products. We analyzed 134 clinical trials from the Chinese Clinical Trial Registry (ChiCTR), 26 IITs, and five BCI-related products approved by the National Medical Products Administration as of June 2026. Results demonstrate that clinical trial registration has increased rapidly since 2020, with research centers concentrated primarily in Guangdong, Shanghai, and Jiangsu. Non-invasive systems predominated, accounting for 79.1% of registered studies, with stroke rehabilitation as the leading indication (65.0%). As of June 2026, five BCI-related products received regulatory approvals, including the world's first approved semi-invasive implantable BCI, an invasive closed-loop deep brain stimulation system with real-time local field potential recording, and three non-invasive EEG-based rehabilitation systems. Collectively, these findings characterize a rapidly expanding BCI translational pipeline in China, spanning from early clinical research to regulatory approval. However, long-term implant stability, standardization of clinical infrastructure and workflows, and generalizability of decoding algorithms remain critical barriers to widespread clinical adoption. Addressing these challenges will be essential for integrating BCI technologies into routine clinical practice.
Comments15 pages, 5 figures, 6 tables. 20260709 update: Added links to full supplementary tables deposited on Zenodo (https://doi.org/10.5281/zenodo.2127219)
