According to news on February 4, Neuralink, created by Elon Musk, aims to change our understanding of brain-computer interfaces and turn science fiction into reality. In a news release on January 29, Musk announced that Neuralink had successfully implanted its "brain-reading" device into the human body for the first time.

Brain-computer interface (BCI) is a bridge between the brain and external devices. This technology captures and decodes brain activity, allowing people who have lost mobility due to severe paralysis to control computers, robotic arms, wheelchairs and other devices with just their thoughts. In addition to Neuralink, other scientific research teams are also competing to develop similar technologies, and some have even entered the human trial stage.

Neurotechnology researchers are cautious yet excited about Neuralink’s human trials. Mariska Vansteensel, a neuroscientist at the University Medical Center in Utrecht, the Netherlands, and president of the International Association for Brain-Computer Interfaces, said: "I look forward to seeing them prove the safety of the technology. From now on, this technology performs well in measuring brain signals, at least in the short term. But the long-term effect is still a key question."

However, public knowledge of the trial was rather limited. Apart from Musk's post, there is no way to confirm whether the trial has actually begun. Furthermore, detailed information about the trial comes primarily from a study brochure for recruiting participants. In this regard, Tim Denison, a neuroengineer at the University of Oxford in the United Kingdom, said: "We need to know more details, such as where the implant surgery will be performed, and what specific results the trial will evaluate."

Even more puzzling is that the trial was not registered on the ClinicalTrials.gov website. The site, run by the National Institutes of Health, is a public repository of scientific research information that requires researchers to publish trial details and protocols before recruiting participants. Many medical journals also regard this as a prerequisite for publishing research results to protect the rights of subjects participating in clinical trials. However, Fremont, California-based Neuralink did not respond to a request for comment on why the trial was not registered on the website.

"Nature" magazine also conducted a comparative analysis of Neuralink's implants and other brain-computer interface technologies. The article pointed out that this trial is not only related to technological progress, but may also raise ethical and privacy concerns.

How is Neuralink's chip different from other BCIs?

Like Salt Lake City, Utah-based Blackrock Neurotech, Neuralink targets the activity of individual neurons, recording with electrodes that penetrate the brain. In contrast, other companies prefer to place electrodes on the surface of the brain and interpret brain activity by recording average signals from groups of neurons.

However, new research suggests that it may be possible to decode more complex cognitive processes, such as inner speech, by averaging signals. New York-based Synchron has successfully demonstrated how low-bandwidth brain surface BCIs can enable basic smartphone control.

The innovation of Neuralink is that it is a fully implantable wireless system, which is the first of its kind in the field of brain-computer interface. Previous implantable systems required a physical connection to a computer through a port in the skull, which not only increased the risk of infection but also limited practical applications.

According to Neuralink's research brochure, its chip contains 64 flexible polymer threads, providing 1,024 sites for recording brain activity. This number far exceeds Blackrock Neurotech’s brain-computer interface device, which is currently the only single-neuron recording system permanently implanted in the human body. Therefore, Neuralink devices are expected to significantly increase the bandwidth of brain-computer communication. In addition, Neuralink specifically emphasized the flexibility of its yarns and said it is developing a robot to implant yarns into the brain.

Tim Denison, a neuroengineer at the University of Oxford in the United Kingdom, appreciates this: "All methods are exciting." But he also emphasized that the question now is which method performs best from the perspectives of safety, signal quality, durability and user experience. "We need sustained technological exploration for the benefit of patients," he said.

What will scientists learn from Neuralink human trials?

Although Neuralink has not released much specific information about the goals of the trial, experts speculate that the main focus of the trial will be on the safety of the device. Dennison noted that at this stage, scientists will pay close attention to the immediate effects of the implanted device, such as whether there are strokes, bleeding, blood vessel damage, etc., while not ignoring the possibility of infection. Long-term follow-up will be key to the evaluation to ensure that the implanted device does not raise any potential safety issues.

Neuralink's research brochure mentions that volunteers will be followed for five years. This time is not only used to evaluate the functionality of the device, but also requires volunteers to use the device at least twice a week to control the computer and provide feedback on the experience.

Mariska van Stinsel, a neuroscientist at the University Medical Center Utrecht in the Netherlands and president of the International Association for Brain-Computer Interfaces, is concerned about the stability of the quality of neural signals. She says it will be critical to understand whether the quality of neuronal signals declines over time after implantation. After all, replacing electrodes is not easy with existing technology, so the maintenance of long-term signal quality is critical to the effectiveness of the device.

Denison is curious about the performance of Neuralink's wireless system. How will this wireless system perform in a non-lab environment?

What concerns do scientists have about NeuralinkBCI?

Human trials of Neuralink have begun, which means the safety and well-being of volunteers has become a top concern. The trial has been approved by the U.S. Food and Drug Administration (FDA), although the agency had previously rejected Neuralink's application. However, some researchers have expressed concern that the trial was not registered on the ClinicalTrials.gov website, which has also raised public concerns about trial transparency and ethical issues.

Dennison expressed concerns about this, saying: "My assumption is that the FDA and Neuralink are complying with the regulations to a certain extent. But the key is that we have not seen the specific protocol, so we cannot understand the specific content and standards of the trial."

Disclosure and transparency of information are particularly important for patients who hope that BCI technology will improve their lives. Ian Burkhart, co-founder of the BCI Pioneer Alliance in Columbus, Ohio, had a Blackrock chip implanted in his brain after being left paralyzed in a diving accident.

Burkhardt is excited about Neuralink's achievements, but he also stresses the importance of disclosure. He believes: "If Neuralink can release more information about the trial, their work will be better understood and supported. Especially for patients who desperately hope that this technology can improve their lives, they have the right to know more details."