"North Brain No. 1" multicenter clinical trial begins; the first participant is expected to regain hand motor function

Taking approximately 4 hours, the first GCP (Good Clinical Practice) multi-center clinical trial implantation surgery of the “North Brain One” intelligent brain-machine system was completed yesterday at Xuanwu Hospital of Capital Medical University. The subject is expected to gradually regain hand motor functions. As a result, the “North Brain One” system, which once attracted global attention, will enter a new stage of standardized, large-scale confirmatory clinical trials. The first batch of 36 patients is planned to be enrolled. The surgery was led and performed by Zhao Guoguang’s team from the Neurosurgery Department of Xuanwu Hospital. In the past year, “North Brain One” has completed 7 patient implantation surgeries, with the device safely operating in the human body for a total of over 45k hours. No serious adverse events occurred throughout the process, and its safety and efficacy have been preliminarily verified. With the successful completion of this surgery, a new phase for “North Brain One” has arrived. Zhao Guoguang explained that GCP multi-center clinical trials are a core step before the system’s market launch. They fill an important gap in transitioning related technology from laboratory research to practical application, marking a new stage for China’s brain-computer interface technology from early exploratory research to standardized, large-scale confirmatory clinical trials. (Beijing Daily)