Brain-Computer Interface Technology Holds Extraordinary Social Significance:ParalysisPatients can regain motor function with the aid of this technology,Parkinson's Disease、Alzheimer's DiseaseBrain diseases, among others, can be treated.Blind PatientsIt is even possible to restore vision through brain-computer interfaces.
Brain-Computer InterfaceThis controversial technology may soon achieve a milestone breakthrough. However, there is still a long and arduous journey ahead to transform it from science fiction into reality.
First Human Trial Approved, but Commercialization May Still Take 10 Years
On Friday local time, Musk was in Paris, FranceVivaTechIt was stated at the event,NeuralinkImplant surgery for paralyzed patients will be performed this year.
Musk did not specify the details of the experiment, only stating that the first human trials might be conducted later this year.
Last month, Neuralink Corp. stated that its first-in-human clinical trialApproved by the U.S. Food and Drug Administration (FDA), a key milestone for the brain-computer interface field and Neuralink.
However, according to experts cited by Reuters, even if the first human trial is successful and Neuralink can prove that its device is safe in humans, obtaining commercial approval for brain-computer interfaces remains a challenge.Neuralink will still need several years, or even more than a decade.
A Dangerous and Great Technology
Brain-computer interface (BCI) refers to the implantation into the human brainElectrode、Chipdevices, establish a direct communication and control channel between the human brain and computers or other electronic devices, thereby achieving the goal of directly controlling external devices using bioelectrical signals from the brain or modulating brain activity through external stimulation. The signals for brain-computer interfaces come fromHuman Central Nervous System, but does not rely on peripheral during transmissionNervous and Muscular Systems。
Therefore, brain-computer interface (BCI) technology holds profound social significance: patients with paralysis can regain motor function through this technology; neurological disorders such as Parkinson’s disease and Alzheimer’s disease can be treated; and even individuals with blindness may restore their vision via brain-computer interfaces.
Based on "invasiveness," brain-computer interfaces can be classified into three categories:Invasive, Non-Invasive, and Semi-Invasive Brain-Computer Interfaces。
Among these, invasive brain-computer interface technology presents the greatest technical challenges. It involves surgically implanting signal acquisition devices (electrodes) directly into the patient’s cerebral cortex. Although this approach yields high-quality, stable signals, it carries a significant risk of triggering immune responses and inflammatory reactions such as glial scarring. Consequently, both the economic costs and safety risks are substantially higher.
Currently, three invasive brain-computer interface companies—Synchron, Onward, and Neuralink—have begun entering the human clinical trial phase.
Synchron, backed by Bill Gates and Jeff Bezos, received FDA approval as early as 2021 and performed the first brain-computer interface implantation in the United States in July 2022. However,The company primarily implants stents into human cerebral blood vessels, rather than directly inserting them to contact brain tissue; therefore, the quality of the signals recorded is relatively moderate.
Neuralink’s invasive approach falls under the “cortical penetration” route, which involves directly implanting flexible electrode threads into the cerebral cortex. Generally, the deeper and closer to the brain tissue itself, the clearer and more accurate the electroencephalographic (EEG) signals become. However, since foreign objects are being implanted into the brain, it is easy to trigger an immune response; the body may form scar tissue between the electrodes and neural tissue, leading to a decline in signal transmission or even complete loss of signal.
But if Neuralink’s first human trial succeeds, it will undoubtedly represent a milestone breakthrough for the entire industry.
Neuralink Faces Numerous Safety Issues, Accidentally Causing Death of Experimental Animals
Since 2019, Musk has stated at least four times that Neuralink would soon begin human trials, but due to ongoing safety concerns failing to pass regulatory review, Neuralink’s human trials have been repeatedly delayed.
According to Reuters, Neuralink, founded in 2016, first applied to the FDA for permission to conduct human trials in early 2022, but the agency rejected the application citing dozens of safety concerns.
Some of these issues concern the success rate of implanting lithium batteries and cables from brain-computer interface devices into the brain, as well as how to safely extract the devices without damaging brain tissue.
Furthermore, due to the diet used in animal experiments, Neuralink is also facing an investigation by U.S. regulators. The data generated from these animal studies are primarily intended to support the company’s application for human clinical trials.
Last year, Reuters reported that due to Musk pressuring employees to seek rapid FDA approval, Neuralink rushed into performing surgeries on pigs, cattle, and sheep without adequate preparation, resulting in the deaths of a large number of animals.
For example, in 2021,NeuralinkImplants of incorrect size were placed in 25 of the 60 pigs. All of the experimental pigs subsequently died. Some employees believed that this error could have been easily avoided with more thorough preparation.
In May, the U.S. Congress urged regulators to investigate Neuralink’s personnel structure; the U.S. Department of Transportation is separately investigating whether Neuralink illegally transported hazardous pathogens extracted from monkey brains without appropriate safety measures; additionally, Neuralink Corp is under investigation by the Office of Inspector General of the U.S. Department of Agriculture for potential violations of animal welfare regulations.
