New York - Elon Musk's controversial biotechnology startup, Neuralink, has announced the commencement of recruitment for its inaugural human clinical trial, as reported in a company blog.
Following the approval from an independent review board, Neuralink is poised to initiate brain implant procedures for patients with paralysis as part of the PRIME Study (Precise Robotically Implanted Brain-Computer Interface). The study aims to assess both the safety and functionality of the brain implant.
Trial participants will undergo surgical placement of a chip within the region of the brain controlling voluntary movements. The chip, administered by a robot, will record and transmit brain signals to a dedicated app, with the initial objective being "to empower individuals to control a computer cursor or keyboard solely through their thoughts," according to the company's statement.
Individuals suffering from quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify for the six-year-long study, comprising 18 months of at-home and clinic visits, followed by additional follow-up visits spanning five years. Interested candidates can register through the patient registry on Neuralink's website.
Elon Musk has been pursuing Neuralink's objective of connecting the human brain to a computer via implants for five years, primarily testing on animals until now. The company faced scrutiny when a monkey died during project testing in 2022 while attempting to play Pong, one of the earliest video games.
Author Walter Isaacson, in a book about Neuralink's founder, revealed that Musk drew inspiration from science fiction authors like Iain Banks to pursue a "neural lace" technology, a human-machine interface implant that can link all thoughts to a computer.
In May, Neuralink announced FDA clearance for human clinical trials, with the FDA confirming this approval in an official statement. The launch of human trials occurred more than a month after Neuralink secured $280 million in a fundraising round led by Founders Fund, a San Francisco-based VC firm established by Peter Thiel, the controversial billionaire and co-founder of PayPal.
"We're incredibly excited about this next phase at Neuralink," the company shared on X, the social media platform formerly known as Twitter, which is owned by Musk.
Musk had previously predicted human trials at Neuralink on at least four occasions since 2019, but the company did not seek FDA approval until 2022. The FDA rejected the application at that time, citing concerns about the implant's migration within the brain and potential brain tissue damage upon removal, as reported by Reuters in March. Musk indicated at a December 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.
However, employees disclosed to Reuters in December that the company was rushing to market, leading to negligent animal deaths and a federal investigation.
Before Neuralink's brain implants can reach the broader market, they must obtain regulatory approval. In 2021, the FDA released a document outlining its preliminary thoughts on brain-computer interface devices, acknowledging the rapid advancements in the field.