Next year, China will conduct 30 to 50 clinical trial implantation surgeries for domestic brain-computer interface technology.
How advanced is China’s brain-computer interface technology? Since the first clinical trial implantation of the brain-computer interface product NEO in Shanghai, what progress has been made by the patients?
On December 6-7, the top academic conference in the global brain-computer interface field, the “BCI Society & Chen Institute Joint Meeting,” was held in Shanghai. The conference was co-hosted by the Tianqiao Brain Science Research Institute and the BCI Association, the most influential academic organization in the field, with special support from Huashan Hospital affiliated with Fudan University (National Center for Neurological Diseases).
During the opening ceremony, Professor Mao Ying, the director of Huashan Hospital and the National Center for Neurological Diseases, presented the current status of the third clinical brain-computer interface device implantation in the country and the first in Shanghai. Currently, the patient is able to pick up and put down a cup and can also open a bottle cap to drink water, just less than a month after the implantation surgery.
According to a report published on November 13, 2024, by the WeChat public account “Shanghai Science and Technology,” on November 6, the brain-computer interface product NEO, developed in collaboration between Boruikang Medical Technology (Shanghai) Co., Ltd. and Professor Hong Bo’s team from Tsinghua University’s School of Biomedical Engineering, successfully completed the third clinical trial implantation surgery in Huashan Hospital. This product was developed and underwent type testing in Shanghai, and in August 2024, it became the first brain-computer interface product in China to enter the special review process for innovative medical devices.
The “Shanghai Science and Technology” WeChat account also stated that the product is still in the clinical trial phase and is expected to obtain a Class III medical device registration certificate after multi-center clinical trials. The patient who underwent the first clinical trial implantation surgery in Shanghai is 38 years old and suffered cervical spinal cord injury due to a car accident, resulting in an inability to grasp objects and stand, with no improvement after four years of rehabilitation. The patient’s recovery has been good, and he was able to get out of bed and sit in a wheelchair three days post-surgery.
According to Mao Ying, the brain-computer interface product features a semi-invasive design, about the size of a coin, implanted just above the patient’s skull and below the scalp. The device uses a wireless minimally invasive design that does not damage brain cells. Additionally, this semi-invasive brain-computer interface product is equipped with an external device responsible for power supply, signal transmission, and real-time algorithm updates, along with a pneumatic glove that the patient can control using brain signals to perform grasping actions.
“Our entire surgery took only 1 hour and 40 minutes, the shortest among the three clinical trial cases, mainly because we used a self-developed electrode implantation precision positioning system, which accurately located the functional area of the brain surface in just 3.3 minutes, significantly reducing the time required for similar surgeries,” Mao Ying further explained. After the implantation of this brain-computer interface product, the patient underwent extensive rehabilitation training, and the entire recovery process was smooth and surprisingly effective, with significant symptom improvement. “From this case, we can see that our current direction in brain-computer interface research is entirely correct, and the brain-computer interface product NEO is completely feasible in clinical applications. We have truly applied a nearly sci-fi brain-computer interface product to patients.”
Previous data indicated that on October 24, 2023, Professor Hong Bo led his team to successfully conduct the first clinical implantation trial of a wireless minimally invasive brain-computer interface at Xuanwu Hospital of Capital Medical University. This patient had suffered complete spinal cord injury in the cervical region due to a car accident and had been in a state of quadriplegia for 14 years. Subsequently, on December 19, 2023, Professor Hong’s team collaborated with Beijing Tiantan Hospital to conduct the second clinical implantation trial, involving a patient who had lost all self-care abilities due to high-level cervical spinal cord injury five years ago. In 2024, the joint research team announced that they had helped two high-level paraplegic patients achieve independent brain-controlled drinking and control of a computer cursor using brain activity through their self-developed semi-invasive brain-computer interface.
Will this clinical research be opened to more patients in the future?
In an interview with The Paper, Hong Bo revealed that the NEO brain-computer interface device will be applied in approximately 30-50 clinical trial implantation surgeries across about 10 centers nationwide next year. “This brain-computer interface device has entered the approval channel for innovative medical devices by the National Medical Products Administration, and we will collaborate with more medical institutions, including those in the western regions, to allow more patients to join the clinical trials. We will also closely monitor the results of the clinical research, summarize the relevant data in a timely manner, and submit it to the National Medical Products Administration,” Hong Bo stated.
