Zhiran Medical Launches China's First Prospective, Multicenter Clinical Trial of a High-Channel (>100) Invasive Brain-Computer Interface System

On May 18, the first prospective, multi-center clinical trial of an over 100-channel invasive brain-computer interface system in China (LEAP study) was launched at Beijing Tiantan Hospital, Capital Medical University. This trial is led by Beijing Tiantan Hospital, Capital Medical University, and initiated by Beijing Bciflex Medical Technology Co., Ltd., marking that China's independently developed high-throughput invasive brain-computer interface technology has entered the fast lane of clinical transformation.

Zhang Long, Director of the Pharmaceutical and Device Department of the Beijing Municipal Health Commission; Zhao Na, Deputy Director of the Device Registration Department of the Beijing Municipal Drug Administration; Yue Xiaolin, Party Secretary of Beijing Tiantan Hospital; Wang Yongjun, Academician of the Chinese Academy of Sciences and President of Beijing Tiantan Hospital; as well as relevant officials from the Beijing Municipal Science and Technology Commission and research team members attended the launch meeting.

The invasive brain-computer interface system used in this research consists of two major modules: intracortical implantable flexible electrodes and a highly integrated fully implantable signal acquisition device. The flexible electrodes, made from ultra-thin biocompatible materials, significantly reduce immune responses post-implantation while precisely capturing single-neuron action potentials with high spatiotemporal resolution. This not only enables the system to decode fine-grained brain electrical information in real time with high accuracy but also achieves an order-of-magnitude increase in the information transmission rate for human-machine interaction. The accompanying fully implantable signal acquisition device features a wireless, fully embedded design, with a built-in medical-grade rechargeable battery that supports wireless charging, allowing for the simultaneous acquisition and transmission of high-channel neural signals. Patients can receive treatment and rehabilitation training in a more natural and comfortable environment, truly meeting the convenience and safety requirements for clinical applications.

Jia Wang, the coordinating investigator of the LEAP study, Deputy Secretary of the Party Committee of Beijing Tiantan Hospital, and a neurosurgery expert, introduced that quadriplegia caused by spinal cord injury is one of the most challenging clinical problems in the field of neurology, with limited effectiveness of existing rehabilitation methods in restoring motor function for this group of patients. This study evaluates the safety and efficacy of an implantable wireless brain-computer interface system for patients with quadriplegia through prospective, multi-center clinical trials. Currently, 11 medical institutions across China have joined the study. The research team will strictly adhere to high-standard clinical protocols to steadily advance the LEAP study, striving to bring hope of clinical intervention to patients while demonstrating the strong independent innovation capabilities of China's cutting-edge technology.