Clinical Translation of Brain-Computer Interface in China: A Landscape Analysis of Investigator-Initiated Trials, Registered Clinical Trials, and Regulatory Approval
For stakeholders in BCI translation and regulation, this paper offers a comprehensive landscape analysis of China's BCI clinical pipeline, but it is primarily a descriptive survey without novel technical contributions.
This paper provides the first quantitative analysis of China's BCI translational ecosystem, analyzing 134 registered clinical trials, 26 investigator-initiated trials, and 5 regulatory-approved products as of June 2026. It finds rapid growth in clinical trials since 2020, with non-invasive systems dominating (79.1%) and stroke rehabilitation as the leading indication (65.0%), and highlights critical barriers to clinical adoption.
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.