BCI devices are on display at the 2nd China Brain-Computer Interfaces Conference held in Wuhan, Central China’s Hubei Province on November 16, 2024. (Zhang Weilan/GT)
“Our brain-computer interface (BCI) device NEO will begin large-scale clinical trials next year, with plans to recruit 30 to 50 patients for implantation across approximately 10 centers nationwide,” Hong Bo, a professor from the School of Medicine at Tsinghua University, told the Global Times on Monday.
This means that China’s domestically developed BCI products are now one step closer to obtaining regulatory approval for market release. According to Hong, the selected participants for next year’s trials will be spinal cord injury patients. Upon completing these implantations, clinical data will be submitted to regulatory authorities to seek approval for the commercialization of the BCI products.
According to domestic news outlet Yicai, NEO was independently developed by Shanghai Neuracle Medical Technology Co, Ltd. This year, three human implantation surgeries have been completed, including one conducted by Huashan Hospital affiliated with Fudan University. NEO completed its development and type testing in Shanghai. In August, it became the first BCI product in China to enter a Special Review Procedure for Innovative Medical Devices of the National Medical Products Administration.
A month ago, the hospital performed surgery on a patient who had been paralyzed for four years following a car accident. By the third day after the operation, the patient was able to get out of bed and sit in a wheelchair. The patient can now use mind control to move their arms and perform simple actions, such as picking up a cup to drink water, according to Mao Ying, president of Huashan Hospital.
Notably, the surgery performed by Mao on this patient took just over an hour, approximately half the time required for the previous two patients. During the procedure, a coin-sized BCI device was precisely implanted into the motor-sensory region of the brain, successfully capturing neural signals.
“Our surgery demonstrates that BCI implantation is highly efficient and has a high degree of standardization. I believe many centers will be able to perform such implantation procedures in the future,” he told Yicai.
Based on the characteristics of the target population, doctors believe that the further development of BCI technology will help many patients with neurological impairments, including those with stroke, regain some basic life abilities. For patients of different age groups, BCIs can be personalized and optimized according to their physical condition. Especially for younger patients, early intervention and rehabilitation training are expected to restore a higher quality of life and improve social abilities.
China has unveiled guidelines to support the technological innovation, industrial cultivation, and safety governance of future industries, including the BCI industry, according to the Xinhua News Agency.
According to the China Academy of Information and Communications Technology’s report on the development and application of BCI 2023, medical treatment stands as the predominant application domain for BCI technology in China.
“Achieving efficient information transfer through the remodeling of neural networks is not only key to understanding brain function but also an important approach for developing new therapeutic methods,” Poo Muming, an academician of the Chinese Academy of Sciences, said at the BCI Society & Chen Institute Joint BCI Meeting.