bioinnovel Chapter 197 Clinical Trials
Chapter 197 Clinical Trials
The day the ethics approval document arrived, Han Lu sent it to Zuo Cheng immediately.
The approval document attached to the document contained only one sentence: "Approval is granted to conduct a clinical trial of brain-computer interface neural signal decoding, with a sample size of no more than three cases, and a phase I safety assessment."
Three cases.
The number is small, but Zuo Cheng knows the significance of this step. In the history of brain-computer interface clinical trials in China, 402 is the first private company to be approved to conduct human trials. Brain-computer teams from several top universities in China have been working on it for more than a decade, but are still stuck in the animal testing stage.
Han Lu sent a message: Congratulations, it's a historic moment.
Zuo Cheng returned. It's not time to celebrate yet; let's get the surgery done first.
Professor Zheng was responsible for selecting volunteers. There were twenty-seven eligible candidates, all of whom were patients with spinal cord injuries leading to motor dysfunction, with the condition having persisted for more than a year and conventional rehabilitation methods proving ineffective. Professor Zheng screened each candidate according to the inclusion criteria and ultimately selected three volunteers.
The first person was Zhang Wei, 35 years old. Two years ago, he suffered a cervical spine fracture and complete C4 segment spinal cord injury in a traffic accident, resulting in the complete loss of motor function in his hands and legs. He spent two years in the hospital and underwent three rehabilitation courses, but without any progress. He heard about the 402 clinical trial and contacted Professor Zheng that same day. When signing the informed consent form, he wrote a line by hand: "I am willing, I believe in you."
The surgery is scheduled for the morning of three weeks from now.
The operating room was located on the second basement floor of the Neurosurgery Center at Huaxia University Hospital, equipped with the most advanced equipment available at the hospital. Professor Zheng personally performed the surgery, assisted by the chief director of neurosurgery, with the 402 technical team providing full support from the monitoring room outside the operating room.
The day before the surgery, Zuo Cheng brought Shen Yiming and Chen Minghui to the hospital to finalize the technical details with Professor Zheng. The NX-30 chip would be implanted semi-invasively, attached to the outer surface of the dura mater without penetrating brain tissue, resulting in minimal surgical trauma. However, the choice of location was crucial for the chip to collect sufficient quality neural signals. Based on Zhang Wei's MRI images, Professor Zheng determined the optimal implantation location and marked it on the surgical planning diagram. Zuo Cheng and Chen Minghui checked the planning diagram three times, and every parameter perfectly matched the previous plan.
Chen Minghui checked the spare chip and confirmed that the communication module was working properly and the signal transmission was stable. Shen Yiming deployed the latest version of the decoding model to the monitoring system in the operating room, allowing for real-time monitoring of signal quality throughout the process.
In the afternoon, Zuo Cheng went to see Zhang Wei alone. Zhang Wei was leaning against the hospital bed, looking quite well. He asked if the surgery tomorrow would be painful. Zuo Cheng said that his upper body would remain conscious, but the surgical area would be under local anesthesia, so there wouldn't be significant pain. Zhang Wei nodded and said, "That's good." After a pause, he added, "Mr. Zuo, my son is nine years old this year. He was seven when I was injured. He hasn't seen me stand up in the past two years." Zuo Cheng didn't answer, only saying, "See you tomorrow."
Everything is ready.
On the morning of the surgery, Zuo Cheng and Shen Yiming sat in the monitoring room. The room wasn't large; a row of monitors at the front displayed live footage from the operating room. Zhang Wei's family waited in the waiting area outside the operating room—Zhang Wei's wife and his elementary school-aged son. The child, unaware of what today meant, sat quietly with a picture book in his hand.
At 7:40, Zhang Wei was wheeled into the operating room.
Zuo Cheng watched the monitor. Zhang Wei was lying on the operating table, his eyes open, half of his body under anesthesia, his upper body still conscious. His expression was calm, showing no fear.
Professor Zheng picked up a scalpel and made a small incision. The surgery went smoothly; the NX-30 chip was attached and positioned along the predetermined path, the electrode array unfolded, and the contact area between the 1024 contacts and the nerve tissue met the design requirements. Chen Minghui stared at the signal curve on the monitoring screen and said, "Signal acquisition has started, and the quality is normal."
Shen Yiming whispered from the side, "The signal-to-noise ratio is 24.1 decibels, which is even better than the laboratory test data."
Suturing, applying pressure, bandaging. The entire surgery took less than two hours.
When Zhang Wei was wheeled back to the recovery room, he was conscious. Professor Zheng stood by his bedside and said, "The surgery went smoothly, the implantation was in the correct position, there was no bleeding, and no damage. You should rest well; we'll do the first signal test tomorrow."
Zhang Wei said, "Thank you." His voice wasn't loud, but it was steady.
Zuo Cheng stood at the door of the recovery room, not going in. He looked at Zhang Wei's profile. Two years of paralysis, yet this man could still calmly say thank you—that required immense endurance. Zhang Wei's wife walked in, took Zhang Wei's hand, and remained silent, her eyes red-rimmed.
Shen Yiming stood next to Zuo Cheng and said in a low voice, "The next step is signal calibration, which will probably take one to two weeks."
Zuo Cheng nodded without saying a word.
Signal calibration, then individualized training of the decoding model, and finally, mind control testing. Each step is a door, and you don't know what's behind it, but you can only move forward. Zuo Cheng mentally created a timeline: two weeks for calibration, four weeks for training, and the mind control testing would begin in the sixth week. If everything went smoothly, the first real test would be in six weeks.
The signal test results on the second day were excellent. The quality of the neural signals collected by the implanted chip was stable, and the signal-to-noise ratio met the laboratory standards. Professor Zheng sent the test report to Zuo Cheng, adding a note: "The equipment is working perfectly and we can proceed to the next stage."
Zuo Cheng forwarded the report to Yu Ying. Yu Ying replied with two words, "That's good." Then she added, "Zhang Wei is very brave."
Zuo Cheng returned, yes.
On the third day, Zhang Wei's wife messaged Tang Ning, saying that Zhang Wei was in good spirits, but his hands seemed to feel a little different; sometimes he would feel a slight numbness, and she asked if this was normal.
Tang Ning sent this message to Zuo Cheng, saying that nerve signals were being collected, corresponding feedback pathways were being established, and it was normal for the patient to feel numbness, indicating that a benign signal exchange had occurred between the implantation site and the nerve tissue. This was a good sign.
As Zuo Cheng read the message, something stirred within him.
After two years of paralysis, this is the first time I've felt a signal from that area. Even if it's just numbness, even if I can't control anything yet, at least the signal is there.
Once the signal calibration is complete and the model is in position, Zhang Wei will be able to issue his first command using his mind. Zuo Cheng doesn't know what he'll feel at that moment, but he knows it will be the most worthwhile thing he's ever done. The nine-year-old child might see his father controlling a mechanical hand for the first time, slowly squeezing and then releasing it.
That's the sound of a door opening.