Three years ago, Musk's brain-computer interface company Neuralink showed the world the real-time neuron activity of three pigs with brain-implanted devices through a live webcast, setting off a "brain-computer craze." At that time, Musk expressed optimism that human trials of brain-computer interfaces would soon begin. But the path to approval for the trial was more complicated than Musk expected.
Image source: Neuralink official website
This week, Neuralink finally received approval for human trials, taking Musk’s science fiction dream of “human-computer symbiosis” a step forward.
Cristin Welle, a former official of the U.S. Food and Drug Administration (FDA) in charge of pharmaceutical supervision and a neurological researcher, told the "Daily Economic News" reporter that this license shows that Neuralink has provided data that meets the FDA's safety requirements.
So after this trial, will the brain-computer interface device be available on the market immediately? "Larger trials are also needed, followed by pivotal trials before applying for premarket authorization (PMA)," Weil explained.
Musk’s dream of “human-machine symbiosis” takes an important step
On September 19, local time, Neuralink announced on its official website that it would recruit participants for the first human clinical trial of its brain-computer interface device to evaluate the safety and preliminary effectiveness of its device, that is, whether paralyzed patients can control external devices with their thoughts.
It is reported that this trial called PRIME (the English abbreviation of Precision Robotic Implantation Brain-Computer Interface) will use the surgical robot R1 to place the implant N1 into the area of the brain that controls movement ideas. The N1 is an ultra-thin flexible wire that records brain signals and transmits them wirelessly to an app that decodes movement intentions.
Neuralink said it is looking for trial participants who have suffered quadriplegia due to spinal cord injury or amyotrophic lateral sclerosis (ALS) and have not improved for at least a year after the injury. The main trial will take approximately 18 months, and including long-term follow-up consultations, the entire clinical trial will take approximately six years.
Four years have passed since Neuralink’s first clinical trial application, during which it was rejected twice by the FDA. At the beginning of 2022, the FDA made it clear that Neuralink needs to solve dozens of issues before conducting human trials. Its safety concerns include the safety of lithium batteries, whether the implant's wires will move to other areas, and safety removal issues, etc. In May 2023, the FDA finally granted Neuralink a conditional trial license.
“The FDA does not disclose review information for clinical trial applications,” Kristen Weil, a former FDA official and current associate professor of neuroscience at the University of Colorado, said in an interview with the Daily Economic News, “But
The initial purpose of this trial is to enable paralyzed people to operate a computer cursor or keyboard using only their thoughts. According to Musk’s statements on many occasions in recent years, Neuralink’s short-term goal is to restore the vision of blind people and allow paralyzed people to restore full-body movement functions.
Just like Musk's dream of immigrating to Mars, brain-computer interfaces also have their science fiction origins. According to the "Elon Musk Biography" just published in September, Neuralink's idea was inspired by Iain Banks's space travel novel "Civilization" series, which mentioned a kind of "neural lace" that, when implanted in the human body, can connect all human thought activities with computers. Musk said: “When I first read Banksy’s work, I suddenly felt that this idea might become our shield in the face of artificial intelligence.”
It may take 5 to 10 years to commercialize
After stumbles, Neuralink has fallen behind its competitors in the progress of human trials.
Synchron, another brain-computer interface company in the United States, has received FDA approval for trials in 2021. In July 2022, it announced the first implantation of a brain-computer interface in the United States and published preliminary trial results. In May 2023, a group of Swiss researchers published an article in Nature magazine, stating that as early as July 2021, a paralyzed man had been implanted with a brain device, allowing him to regain his ability to walk with the help of a walker.
Of course, Neuralink still has its own technical advantages. Traditional implantable brain-computer interfaces use a hard electrode called the "Utaharray", while Neuralink uses flexible electrodes, which can reduce the brain's rejection reaction and the quality of the neural information it collects is also relatively high. In addition, Neuralink has developed a robot for brain-computer interface surgery, which will minimize the trauma when implanting and removing the device.
To realize Musk's grand vision, this human trial is just a small step forward. "
Kristen Weil further explained to reporters that after this small-scale human trial, Neuralink will apply for a larger-scale feasibility trial based on the experimental data; since brain implant devices are likely to be classified as equipment with the highest risk level (Class III), Neuralink must also apply for a pre-market license before being launched on the market. This means that Neuralink also needs to conduct a large-scale pivotal trial (pivotal trial), that is, to prove that its equipment can indeed treat a specific symptom and is safe and reliable.
This process requires a lot of money and time. Kristen Weil previously told the media,
On the other hand, Neuralink also faces challenges from multiple technologies and application prospects. Kristen Weil pointed out in every reporter’s analysis,
"Even if Neuralink can meet all these conditions, the device will definitely be expensive and require surgery on the brain, so the number of patients willing to accept the implant may be relatively small." Kristen Weil said.