Elon Musk's Brain Implant Startup Takes Stride Towards Human Trials


Elon Musk’s pioneering biotechnology venture, Neuralink, has announced the commencement of recruitment for its inaugural human clinical trial. Following the green light from an independent review board, Neuralink is poised to offer brain implants to individuals affected by paralysis as part of the PRIME Study. PRIME, which stands for Precise Robotically Implanted Brain-Computer Interface, aims to assess both the safety and efficacy of the implant.

Participants in the trial will undergo a surgical procedure in which a chip is placed in the brain region responsible for movement intention. This chip, implanted by a robot, will then record and transmit brain signals to an application. The initial objective is to enable individuals to control a computer cursor or keyboard solely through their thoughts, as detailed by the company.

Individuals suffering from quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may be eligible for this extensive six-year study, which includes 18 months of at-home and clinic visits followed by five years of follow-up assessments. Those interested can register in the patient registry on Neuralink’s official website.

Elon Musk has dedicated five years to Neuralink's mission of establishing a connection between the human brain and a computer using implants, although the company has hitherto focused solely on animal testing. The venture faced scrutiny after a monkey passed away during a project test in 2022, which aimed to train the animal to play Pong, one of the earliest video games.

Walter Isaacson, in his recently published book on Neuralink's founder, revealed that Musk drew inspiration from science fiction writers like Iain Banks to pursue a "human-machine interface technology called 'neural lace'" capable of implantation and connecting all of an individual's thoughts to a computer.

In May, Neuralink announced on Twitter that it had obtained FDA clearance for human clinical trials, with the approval officially acknowledged by the agency. The launch of human trials comes a little over a month after the brain chip startup secured $280 million in funding, led by Founders Fund, a venture capital firm based in San Francisco established by Peter Thiel, the controversial billionaire and co-founder of PayPal.

"We're extremely excited about this next chapter at Neuralink," the company shared at the time on X, Musk's social media platform.

Although Musk had projected human trials at Neuralink on multiple occasions since 2019, the company did not seek FDA approval until 2022. The agency initially rejected the application, expressing concerns about certain parts of the implant potentially shifting within the brain and potential brain tissue damage upon removal, as per a Reuters report from March. Musk stated at a recruiting event in December that Neuralink had submitted "most" of its paperwork to the FDA and could commence human testing within six months.

However, employees informed Reuters in December that the company was rushing to market, resulting in negligent animal fatalities and triggering a federal investigation.

As Neuralink's brain implants move towards wider accessibility, regulatory approval will be a crucial milestone. The FDA released a document in 2021 outlining its initial considerations on brain-computer interface devices, acknowledging the swift progress in the field.