Clinical Translation of Brain-Computer Interface in China: A Landscape Analysis of Investigator-Initiated Trials, Registered Clinical Trials, and Regulatory Approval

This study provides the first comprehensive quantitative analysis of the brain-computer interface (BCI) translational ecosystem in China. By integrating data from investigator-initiated trials (IITs), registered clinical trials, and regulatory-approved products, the authors map the evolution of the field from 2013 to 2026. The research highlights a significant acceleration in clinical activity, particularly since 2020, driven by national policy initiatives and the establishment of expedited regulatory pathways.

The authors systematically reviewed 134 registered clinical trials, 26 investigator-initiated trials, and five regulatory-approved products. The findings reveal a three-tier translational hierarchy: IITs for early proof-of-concept, registered trials for protocolized evidence, and NMPA-approved products for clinical use. Non-invasive EEG-based systems currently dominate the landscape, accounting for nearly 80% of registered studies, primarily targeting stroke rehabilitation. Geographically, research is concentrated in Guangdong, Shanghai, and Jiangsu, reflecting a multipolar distribution of clinical and engineering expertise.

A major highlight of the study is the maturation of the regulatory environment. As of June 2026, China has approved five BCI-related products, including the world's first Class III regulatory approval for a semi-invasive BCI system. These approvals signify a transition from isolated academic feasibility demonstrations to a structured, multi-route clinical pipeline. The study notes that while non-invasive systems are the most prevalent, there is a clear trend toward more sophisticated, implantable, and closed-loop neuromodulation technologies.