What do scientists think about the first human experiment?

Neuralink, the company that entrepreneur Elon Musk hopes to revolutionize in brain-computer interfaces (BCI), has implanted the first “brain-reading” device in a human, according to reports. Tweet posted by Musk on January 29th.

BCIs record and decipher brain activity with the goal of allowing people with severe paralysis to control computers, robotic arms, wheelchairs, and other devices using just their thoughts. Apart from Neuralink’s device, other devices are in development, and some have already been tested on humans.

Neurotechnology researchers are cautiously excited about Neuralink’s human trials. “My hope is that they can prove it’s safe. And it’s effective in measuring brain signals in the short term, but most importantly in the long term.” says Mariska Vansteensel, a neuroscientist at Utrecht University Medical Center in the Netherlands and president of the International BCI Association.

However, I am frustrated by the lack of detailed information. Other than Musk’s tweets, there is no confirmation that a trial has begun. The main public source of information about this trial is a study brochure inviting people to participate in the trial. However, this lacks details such as where the implant will be performed and the exact results the trial will assess, says Tim Dennison, a neuroengineer at the University of Oxford in the UK.

This trial is not registered with ClinicalTrials.gov, an online repository maintained by the National Institutes of Health. Many universities require researchers to register their trials and their protocols in this type of public repository before study participants are enrolled. Furthermore, many medical journals make such registration a condition for publication of results, in line with ethical principles aimed at protecting people who volunteer in clinical trials. Neuralink, headquartered in Fremont, California, did not respond to questions. Natureis seeking comment on why the trial was not registered on the site.

Nature We examine how Neuralink’s implant compares to other BCI technologies, how this trial advances BCI, and researchers’ concerns.

How is this chip different from other BCIs?

Like BlackRock Neurotech in Salt Lake City, Utah, Neuralink targets the activity of individual neurons, an approach that requires electrodes that penetrate the brain. Other companies are developing electrodes (some easily removable) that sit on the surface of the brain to record the average signal produced by populations of neurons. Neuroscientists have long argued that deciphering higher-level thinking requires data from individual neurons. However, recent research has shown that the averaged signal allows us to decipher complex cognitive processes, such as our inner speech.¹. And New York City-based company Synchron has shown that low-bandwidth surface BCIs can provide basic and reliable smartphone control.².

Like the Synchron system, Neuralink is fully embedded and wireless. This is the first BCI to record from individual neurons. Previous such systems required a physical connection to the computer through a port in the skull. This poses an infection risk and limits practical use.

According to the company’s research brochure, the Neuralink chip contains 64 flexible polymer threads, providing 1,024 sites for recording brain activity. This is considerably more than BlackRock Neurotech’s BCI, the only single-neuron recording system implanted long-term in humans. Therefore, while Neuralink devices have the potential to increase the bandwidth of brain-machine communication, some users have multiple Blackrock devices implanted. Neuralink touts the flexibility of threads and says it is developing a robot that inserts threads into the brain.

Dennison says the different approaches are interesting. Now you need to figure out which one will perform best in terms of safety, signal quality and durability, and user experience. “We all need to play the long game in the interest of patients,” he says.

What will scientists learn from Neuralink’s human trials?

Neuralink has released little information about the purpose of the exam and has not responded. NatureInterview request from. But experts expect safety to be the top priority at this stage. Dennison said this includes looking at the immediate effects of the device — “no strokes, no bleeding, no damage to the vascular system, etc.” It says it will include long-term follow-up to ensure it is safe. Embedded device.

Neuralink’s study brochure states that volunteers will be followed for five years. The trial will also assess the functionality of the device, with volunteers using it at least twice a week to control a computer and provide feedback on their experience.

Vansteensel wants to know whether the quality of the detected neuron signals degrades over time, which is common with existing devices. “The electrodes cannot be easily replaced after implantation,” she says. “If she shows beautiful decoding results a month from now, that would be great. But I would like to see long-term results.”

Dennison also wants to learn how wireless systems work that can be used in environments outside of the lab.

What concerns do scientists have about Neuralink BCI?

Now that human trials have begun, the safety and well-being of volunteers is a pressing issue. The trial was approved by the U.S. Food and Drug Administration (FDA), which rejected an earlier application from Neuralink. But some researchers are unhappy that the trial is not listed on ClinicalTrials.gov. “My guess is that the FDA and he think Neuralink is following this strategy to some extent,” Dennison says. “But we don’t have a protocol. So we don’t know that.”

Transparency is also important to the people BCI serves. Ian Burkhart, co-founder of the Columbus, Ohio-based BCI Pioneer Coalition, was paralyzed after a diving accident broke his neck and spent seven and a half years with a BlackRock array implanted in his brain. He is excited about what Neuralink will accomplish. But he says: “We could have done a better job instead of leaving everyone guessing about how much information to release, especially for patients whose lives are looking forward to being improved by this type of technology.”