China Conducts First Prospective Clinical Trial of Invasive Bci

China Pioneers Clinical Trial of Advanced Brain-Computer Interface

The Chinese mainland has successfully conducted its first prospective clinical trial of an invasive brain-computer interface (BCI), marking a significant leap in neurotechnology. This groundbreaking trial is a collaborative effort by the Center for Excellence in Brain Science and Intelligence Technology (CEBSIT) under the Chinese Academy of Sciences, Fudan University’s Huashan Hospital, and industry partners.

With this achievement, China becomes the second country globally to enter the clinical trial phase for invasive BCI technology. The trial centers on a man who lost all four limbs in a high-voltage accident. Since the implantation of the BCI system in March 2025, the device has operated steadily. Remarkably, after just two to three weeks of training, the patient was able to play chess and racing games using his brain signals, controlling them as adeptly as a healthy person using a computer touchpad.

The success of this trial offers promising future applications for individuals with spinal cord injuries, amputations, and other motor impairments. The technology could significantly improve their quality of life by restoring their ability to interact with the world.

The neural electrode developed by CEBSIT is currently the world’s smallest and most flexible of its kind. Its ultra-flexible design allows it to interface with brain tissue with minimal disruption, reducing potential damage and immune response. The electrode is capable of long-term, high-density, and high-throughput recording of neural signals across large brain areas. Prior to this human trial, it was successfully tested in rodents and non-human primates.

This innovation addresses key limitations of earlier implantable BCIs, such as poor biocompatibility and limited signal bandwidth. In terms of surgical design, CEBSIT’s implant is also the smallest BCI device globally, measuring just 26mm in diameter and less than 6mm in thickness—roughly the size of a coin. Unlike traditional implants that require full penetration of the skull, this system is embedded into a coin-sized recess on the surface of the skull above the motor cortex, requiring only a 5mm puncture hole through the bone.

Using a minimally invasive neurosurgical approach, the procedure significantly reduces surgical risks and shortens recovery time. Precision in mapping and implantation is critical to the system’s success. Before surgery, Huashan Hospital employed a combination of functional MRI, human brain atlases, and individualized 3D brain modeling to create a detailed map of the patient’s motor cortex. This enabled millimeter-level accuracy in electrode placement, ensuring both safety and signal fidelity.

The next phase of the project will explore enabling the patient to use a robotic arm to perform tasks such as grasping and lifting objects in real life. Future developments aim to extend control to more complex physical devices like quadruped robots and embodied intelligent agents, expanding the boundaries of physical independence and interaction.

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