In an announcement that has sent proverbial shockwaves dashing across the neurotechnology landscape, Elon Musk’s fairly nascent startup Neuralink has blown the recruitment bugle for its first-in-human clinical trial. This trial seeks to implement a wireless brain-computer interface implant. Invented by minds pushing the boundaries of our understanding of the human brain, this groundbreaking technology termed PRIME Study (Precise Robotically Implanted Brain-Computer Interface) could be the lifeline for those grappling with severe degenerative diseases like amyotrophic lateral sclerosis (ALS).
💥 BREAKING: Neuralink’s First-in-Human Clinical Trial is Open for Recruitment
Neuralink received approval from the reviewing independent institutional review board and first hospital site to begin recruitment for the first-in-human clinical trial.https://t.co/nRdIRgNxfA
— Tesla Hype (@TeslaHype) September 19, 2023
The PRIME Study aims to prove the safety and check the functionality of the robotic implant. The goal, as ambitious as it is transformational, is to grant people the power to manipulate computers using nothing but their thoughts. The robustly fine and flexible threads of “N1 Implant” will be surgically situated by an “R1 Robot” in the brain area governing movement intention. This implantation process, according to the company’s statement, would render the N1 cosmetically invisible and capable of recording and transmitting brain signals wirelessly to an app that deciphers movement intention.
Key considerations for potential applicants are quadriplegia and a history of cervical spinal cord injury or ALS. The visionary behind the Neuralink route-map, Musk, has on various occasions propagated this medical marvel’s capacity to treat neurological disorders, from paralysis to blindness. Given its ability to bridge signals among existing neurons and even facilitate the saving and replay of memories, Musk states, “the future is going to be weird.”
Interestingly, Musk—always one to put his own skin in the game—proclaimed at a recruitment event in 2021 that he himself would likely be implanted with the neurotechnology. He declared, with his trademark audacity, “You could have a Neuralink device implanted right now, and you wouldn’t even know.”
Despite Neuralink’s initial FDA approval received in May and a breakthrough designation three years ago, the road to human trials had been a rocky one due to safety concerns raised by the FDA. Seven anonymous FDA insiders revealed that the device’s lithium battery, the potential for the tiny wires to migrate critically, and questions around safe removal of the device were among the agency’s concerns.
As expected, Musk and Neuralink are leaving no stone unturned in their pursuit of this medical miracle. Their commitment to safety and ethical practices is evident from their assurance to the public: “We want to be extremely careful and certain that it will work well before putting a device into a human.” Their mission, while seemingly sluggish, is working on parallel developments to expedite the progress exponentially.
However, not all sun shines brightly on Neuralink. Investigations into accusations of hurrying animal testing and breaches in animal welfare, alongside probes concerning the movement of hazardous pathogens—this clinical triumph comes shadowed by a plethora of concerns, particularly surrounding its operations and trial methods.
As an epoch-making steppingstone in the field of neurotechnology, Neuralink’s foray into human clinical trials is undeniably monumental. Yet, the journey is flecked with multifaceted challenges encapsulating ethics, regulatory compliance, and universal scientific acceptance. As we inevitably progress into the tantalizing era of neurotechnological influence on human functionalities, Neuralink sessions continue to bid citizen and scientific community alike to partake in and witness what could potentially redefine the bounds of human capability. Regardless of the eventual outcome, the pursuit of pushing boundaries, disrupting evolutionary norms, and championing the extraordinary remains undeterred, proving that the annals of human ambition are far from filled.