China to Initiate 30–50 Implant Surgeries in Multicenter Clinical Trial of Domestic NEO Brain-Computer Interface Next Year

What is the current level of brain-computer interface technology in China? How has the patient progressed since the first clinical trial implantation surgery of the brain-computer interface product NEO in Shanghai?

On December 6th-7th, the top academic conference in the global brain-computer interface field, "BCI Society & Chen Institute Joint Meeting," was held in Shanghai. The conference was jointly organized by the TCCI (Tianqiao and Chrissy Chen Institute) and the BCI Society, the most influential academic institution in the brain-computer interface field globally, with special support from Huashan Hospital Affiliated to Fudan University (National Center for Neurological Diseases).

At the opening ceremony of the conference, Professor Mao Ying, Dean of Huashan Hospital Affiliated to Fudan University and Director of the National Center for Neurological Diseases, played a video showing the recent condition of the third patient in China and the first in Shanghai who received the implantation of a clinical brain-computer interface device. Currently, the patient is able to pick up and put down a cup, and can also unscrew bottle caps to drink water. Remarkably, this progress has been achieved in less than a month after the completion of his implant surgery.

According to a message published on the WeChat Official Account "Shanghai Science and Technology" on November 13, 2024, on November 6, the brain-computer interface product NEO, co-developed by Neuracle Medical Technology (Shanghai) Co., Ltd. and Professor Hong Bo's team from Tsinghua University's Biomedical Engineering Department, successfully completed the third clinical trial implant surgery in China and the first in Shanghai at Huashan Hospital. The product was developed and underwent type inspection 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 WeChat Official Account "Shanghai Technology" also reported that the aforementioned product is still in the clinical trial stage and is expected to obtain a Class III medical device registration certificate after completing multi-center clinical trials. The patient in the first clinical trial implant surgery in Shanghai was 38 years old, with cervical spinal cord injury caused by a car accident, unable to grip with hands or stand, and showed no improvement after four years of rehabilitation. The patient recovered well after the surgery and was able to get out of bed and sit in a wheelchair on the third day.

According to Mao Ying's introduction, during the entire surgical procedure, this brain-computer interface product adopts a semi-invasive design, with a size as small as a coin. It is implanted just above the patient’s skull and beneath the scalp. The device features a wireless minimally invasive design that does not damage brain cells. Additionally, this semi-invasive brain-computer interface product comes with an external setup. The external equipment is responsible for power supply, signal transmission, and real-time algorithm updates. There is also a pneumatic glove that patients can control through EEG signals to perform actions such as grasping.

"The entire operation took only 1 hour and 40 minutes, the shortest among the three clinical trial cases. This is mainly because we used our self-developed electrode implantation precision positioning system, which accurately located the functional areas of the brain surface in just 3.3 minutes, significantly reducing the operation time for similar surgeries," said Mao Ying. He further introduced that after the implantation of this brain-computer interface product, the patient underwent extensive rehabilitation training, and the entire recovery process went very smoothly, beyond everyone's expectations, with significant improvement in symptoms. "From this case, we can see that the direction of our current brain-computer interface research is entirely correct, and the brain-computer interface product NEO used is also completely feasible in clinical practice. We have truly applied a nearly sci-fi brain-computer interface product to patients."

Previously, data showed that on October 24, 2023, Professor Hong Bo led a team in designing and developing a wireless minimally invasive implantable brain-computer interface, which successfully conducted the first clinical implantation trial in China at Xuanwu Hospital, Capital Medical University. The patient had suffered a complete spinal cord injury at the cervical spine due to a car accident and had been quadriplegic for 14 years. Subsequently, on December 19, 2023, Professor Hong Bo's team collaborated with Beijing Tiantan Hospital to carry out the second clinical implantation trial in China. This patient had been rendered a high-level paraplegic at the C3-C4 cervical vertebrae segment following an accident five years prior, completely losing self-care ability. In 2024, the aforementioned joint research team announced that through their independently developed semi-invasive brain-computer interface, they had helped two high-level paraplegic patients respectively achieve autonomous brain-controlled drinking and control of a computer cursor movement using brain electrical activity.

In the future, will this clinical research be open to more patients?

Hong Bo revealed in an interview with The Paper that the NEO brain-computer interface device will be applied in 30 to 50 brain-computer interface clinical trial implant surgeries across approximately 10 centers in China next year. "This brain-computer interface device has entered the National Medical Products Administration's innovative medical device approval channel. In the future, we will collaborate with more medical institutions, including those in western China, allowing more patients to participate in clinical trials. We will also closely monitor the results of the clinical research, promptly summarize relevant data, and submit it to the National Medical Products Administration," said Hong Bo.

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