Neuralink, the brain-implant venture spearheaded by tech mogul Elon Musk, has achieved a significant milestone. It has garnered the nod from an independent review board to commence the recruitment of participants for its inaugural human trial. This groundbreaking initiative seeks individuals grappling with paralysis to partake in a six-year-long exploration of its experimental neurotechnology.
While Neuralink stands amongst a cohort of companies delving into the realm of brain-computer interfaces (BCI) for the aggregation and interpretation of cerebral signals, it is Musk’s grandiloquent proclamations about the venture that have garnered both skepticism and ethical scrutiny from the neuroscience and expert communities. Musk’s extravagant promises, including the creation of a comprehensive brain-computer system to complement human intelligence vis-à-vis artificial intelligence, have been a subject of debate.
Notably, last year, the Food and Drug Administration (FDA) declined Neuralink’s request for an expedited human trial, but later, in May, it accorded Neuralink an investigational device exemption (IDE), which permits device usage in clinical investigations. The specifics of how the FDA resolved its initial reservations remain undisclosed.
Neuralink is actively searching for individuals afflicted by quadriplegia stemming from vertical spinal cord injuries or Amyotrophic lateral sclerosis (ALS) to be the protagonists of this transformative journey. These participants will undergo a surgical implantation of the BCI, facilitated by a proprietary robotic system, in a region of the brain responsible for motor control. The ultimate goal? Empowering these individuals to command a computer cursor or keyboard through sheer mental intent. The study’s primary focus lies in evaluating the technology’s safety and functionality, as elucidated in a company statement.
This revelation arrives on the heels of prior regulatory endorsements for Neuralink’s trial. However, the organization’s past animal testing initiatives have come under intense scrutiny following allegations of undue suffering inflicted during trials. Former employees have characterized these procedures as suboptimal, even referring to them as “hack jobs.” Reports surfaced regarding erroneous device placements in pigs, leading to their euthanasia.
These allegations have catalyzed a string of investigations, encompassing a probe by the Department of Agriculture into animal welfare concerns and the Department of Transportation’s inquiry into the mismanagement of biohazardous materials across state boundaries.
As of now, Neuralink has not divulged specifics regarding the trial’s commencement date, location, or the number of participants involved. Should the device prove safe for human use, it remains conceivable that substantial time may elapse before it attains clearance for utilization beyond the confines of this trial.
With contributions from Reuters