New York — Neuralink, the biotechnology startup founded by Elon Musk, is gearing up to initiate its first human clinical trial, as reported in a recent company blog post. Following approval from an independent review board, Neuralink is launching the PRIME Study, an acronym for “Precise Robotically Implanted Brain-Computer Interface,” to assess the safety and functionality of brain implants.
In this groundbreaking trial, patients with paralysis will undergo a surgical procedure to implant a chip into the region of their brain responsible for controlling movement intentions. Utilizing a robotic procedure, this chip will record and transmit brain signals to an accompanying app. The initial objective is to empower individuals to control a computer cursor or keyboard solely through their thoughts, a remarkable advancement.
Individuals afflicted with quadriplegia due to cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS) may qualify for this six-year-long study, which includes 18 months of at-home and clinic visits, followed by ongoing follow-up appointments over the subsequent five years. Interested individuals can enroll in the patient registry via Neuralink’s official website.
Elon Musk has been dedicated to Neuralink’s mission of establishing brain-computer connections for half a decade, but the company had only conducted animal testing until now. It gained notoriety after a monkey died during project testing in 2022, which aimed to enable the animal to play Pong, one of the earliest video games.
Walter Isaacson, an author who has delved into the life of Neuralink’s founder, revealed that Musk drew inspiration from science fiction writers like Iain Banks. These inspirations led Musk to pursue the concept of a “neural lace,” a human-machine interface technology that can be implanted into people to connect their thoughts directly to a computer.
In May, Neuralink announced on Twitter that it had obtained FDA clearance for human clinical trials, a milestone acknowledged by the regulatory agency in an official statement. The commencement of human trials follows just over a month after Neuralink raised an impressive $280 million in a fundraising round led by Founders Fund, a venture capital firm based in San Francisco, founded by the controversial billionaire and PayPal co-founder, Peter Thiel.
In a statement on X, a social media platform owned by Musk (formerly known as Twitter), Neuralink expressed immense enthusiasm for this new phase of development.
It’s worth noting that Musk had previously predicted human trials for Neuralink on at least four occasions since 2019, but the company only sought FDA approval in 2022. At that time, the FDA rejected the application, citing concerns about the safety of certain implant components migrating within the brain and potential brain tissue damage during device removal. Musk mentioned in a recruiting event in December that Neuralink had submitted most of its paperwork to the US Food and Drug Administration and could commence human testing within six months.
However, employees disclosed to Reuters in December that the company was rushing to market, resulting in unfortunate animal fatalities and a federal investigation.
As Neuralink’s brain implants move closer to wider availability, they will require regulatory approval. The FDA published a document in 2021 outlining its preliminary perspectives on brain-computer interface devices, recognizing the rapid progress in this field.