Elon Musk’s controversial biotech venture, Neuralink, has commenced recruitment for its inaugural human clinical trial, as reported in the company’s recent blog post. Following approval from an independent review board, Neuralink is preparing to offer brain implants to patients with paralysis as part of the PRIME Study, officially known as the “Precise Robotically Implanted Brain-Computer Interface.” The study’s primary objective is to assess both the safety and functionality of the brain implant.
Participants in the trial will undergo a surgical procedure to implant a chip into the brain region responsible for motor intention. This chip, inserted by a robot, will record and transmit brain signals to a dedicated app. The initial aim is to enable individuals to control a computer cursor or keyboard solely through their thoughts. Eligibility for the six-year study is extended to individuals with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS). The study comprises 18 months of at-home and clinic visits, followed by five years of follow-up appointments. Interested individuals can register in the patient registry on Neuralink’s website.
Elon Musk has been actively pursuing Neuralink’s goal of connecting the human brain to a computer through implants for five years. However, the company has thus far conducted tests only on animals. Neuralink also faced scrutiny when a monkey died during a project test in 2022, which aimed to teach the animal to play Pong, one of the first video games.
In Walter Isaacson’s recent book about Neuralink’s founder, it was revealed that Musk drew inspiration from science fiction authors like Iain Banks in his quest to develop a “neural lace,” a human-machine interface technology implanted into people to connect all their thoughts to a computer. In May, Neuralink announced on Twitter that it had obtained FDA clearance for human clinical trials, with the approval later confirmed by the agency in an official statement. The commencement of human trials comes over a month after the brain chip startup raised $280 million in a funding round led by Founders Fund, a San Francisco-based VC firm co-founded by Peter Thiel, the controversial billionaire who was also a co-founder of PayPal.
In response to these developments, Neuralink expressed its excitement, stating, “We’re extremely excited about this next chapter at Neuralink” on X, the social media platform owned by Musk, formerly known as Twitter.
Musk had previously projected human trials at Neuralink on at least four occasions since 2019, but the company did not seek FDA approval until 2022. During that application process, the FDA reportedly rejected the bid due to safety concerns, including potential implant migration within the brain and the possibility of brain tissue damage during device removal. In December, Musk mentioned at a recruitment event that Neuralink had submitted most of its paperwork to the US Food and Drug Administration and could commence human testing within six months. Nevertheless, employees disclosed to Reuters in December that the company’s rush to market had resulted in unfortunate animal deaths and triggered a federal investigation.
