Elon Musk recently announced that a third individual has received an implant from Neuralink, his brain-computer interface company, which is among several groups aiming to bridge the nervous system with technology. Musk emphasized that all three human recipients of the Neuralink implants are functioning well, during an extensive interview streamed on his social media platform, X, at a Las Vegas event.
Since initiating the first brain implant approximately a year ago, Neuralink has made advancements by increasing the number of electrodes, improving bandwidth, and extending battery duration. Musk expressed the company’s aspirations to have the experimental devices implanted into an additional 20 to 30 individuals within the year. While specifics about the latest recipient remained undisclosed, updates were shared regarding the earlier patients.
The second recipient, who suffered from a spinal cord injury, received the implant last summer and has begun to play video games using the technology, alongside learning to utilize computer-aided design software for creating three-dimensional objects. The first patient, also paralyzed due to spinal cord injury, shared how the device enabled him to engage in video games and play chess.
Despite Neuralink’s notable headlines, many other firms and research groups are exploring similar innovations. Two separate studies published in the New England Journal of Medicine in the past year highlighted how brain-computer interfaces (BCIs) have improved communication for individuals grappling with ALS.
Currently, over 45 studies involving BCIs are in progress, as reported by a U.S. study database. These efforts are dedicated to addressing brain disorders, repairing brain injuries, and exploring other potential applications. Rajesh Rao, co-director of the Center for Neurotechnology at the University of Washington, mentioned that various research labs have successfully demonstrated that individuals can effectively manage computer cursors through BCIs.
Rao pointed out that Neuralink might stand out in two significant aspects: the surgical implementation of its device, which is the first instance of employing a robot to insert flexible electrode threads within the human brain for recording neural activities and interfacing with devices. Moreover, these threads may have the capability to capture activity from a greater number of neurons compared to alternative interfaces.
Nonetheless, Rao conveyed that the advantages of Neuralink’s methodology have yet to be substantiated, and some competitors have surpassed the company in certain respects. He noted that firms like Synchron, Blackrock Neurotech, and Onward Medical are currently conducting BCI trials using less invasive methods or more adaptable techniques that merge neural recording with stimulation.
Marco Baptista, the chief scientific officer of the Christopher & Dana Reeve Foundation, described the potential advantages that BCI technology could offer to individuals with paralysis as “very exciting.” He expressed that through clinical trials, it should become evident which approach proves to be the most effective, but acknowledged that it remains too early for definitive conclusions.
Baptista’s foundation typically supports research endeavors financially and with expertise; however, he confirmed they have not provided any funding to Neuralink. “It’s essential to back high-risk, high-reward projects such as this,” he noted. “We can’t predict how safe or feasible this will be.”
Neuralink revealed in 2023 that it had received approval from U.S. regulators to start testing its devices on human subjects. Unlike many medical devices that can enter the market without extensive clinical trials, high-risk devices must undergo a rigorous pre-market approval process, known as an “investigational device exemption,” from the Food and Drug Administration (FDA), as explained by Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who focuses on high-risk devices.
Though Neuralink asserts that it possesses this exemption, the FDA is unable to confirm or disclose particulars about the study in question. Redberg noted that the FDA is actively involved in all stages, from patient recruitment to the trials and data evaluation, emphasizing that this regulatory procedure prioritizes safety.
Moreover, Redberg underscored an additional layer of protection: all human research requires approval from an institutional review board (IRB), which can also be referred to as an ethical review board or an independent ethics committee. Members of such boards must include at minimum one non-scientist, as well as an individual not affiliated with the institution establishing the board.
These panels are tasked with evaluating risk versus potential benefits while ensuring that patients are adequately informed before they consent to participate, according to Redberg.
