Elon Musk's brain Implant Firm sets to start trials on humans

Elon Musk’s brain implant firm sets to start trials on humans

Elon Musk’s contentious biotech venture, Neuralink, has initiated the recruitment process for its inaugural human clinical trial, according to a recent company blog post.

Following approval from an independent review board, Neuralink is now prepared to offer brain implants to individuals with paralysis as part of the PRIME Study, short for “Precise Robotically Implanted Brain-Computer Interface.”

This study aims to assess the safety and functionality of the brain implant.

Trial participants will undergo a surgical procedure in which a chip is implanted into the region of the brain responsible for controlling movement intentions.

This chip, installed by a robot, will record and transmit brain signals to an app, with the initial objective being to enable individuals to control a computer cursor or keyboard solely through their thoughts, as stated by the company.

Individuals with quadriplegia resulting from cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS) may be eligible to participate in this six-year-long study, which involves 18 months of at-home and clinic visits, followed by additional follow-up appointments over five years. Interested individuals can register in the patient registry on Neuralink’s website.

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Elon Musk has been pursuing Neuralink’s vision of connecting the human brain to a computer through implants for five years, primarily focusing on animal testing during this time.

The company faced criticism after a monkey died during a project test in 2022, part of an experiment aiming to enable the primate to play Pong, one of the earliest video games.

In May, Neuralink announced on social media that it had received FDA clearance for human clinical trials, with the approval subsequently acknowledged by the agency in an official statement.

The commencement of human trials comes approximately one month after the brain chip startup secured $280 million in funding through a round led by Founders Fund, a venture capital firm based in San Francisco, established by Peter Thiel, a controversial billionaire who also co-founded PayPal.

Neuralink expressed excitement about this significant milestone, emphasizing its commitment to advancing the field.

Elon Musk had previously projected human trials at Neuralink on at least four occasions since 2019, although the company did not seek FDA approval until 2022.

At that time, the agency rejected the application, citing concerns about the implant’s potential migration within the brain and potential brain tissue damage during removal.

Musk mentioned in 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.

Reports in December from employees raised concerns about the company’s rush to market, leading to careless animal deaths and a federal investigation.

As Neuralink moves toward bringing its brain implants to a broader audience, regulatory approvals will be essential. In 2021, the FDA released a document outlining its initial thoughts on brain-computer interface devices, acknowledging the rapid progress in the field.