Neuralink, the biotechnology startup founded by Elon Musk, has initiated the recruitment process for its inaugural human clinical trial, as reported in a company blog post. Following the green light from an independent review board, Neuralink is embarking on the PRIME Study (Precise Robotically Implanted Brain-Computer Interface). This study aims to assess both the safety and functionality of brain implants, which will be offered to individuals suffering from paralysis.
In the trial, patients will undergo surgery to implant a chip in the region of the brain responsible for controlling movement intentions. Utilizing a robot, this chip will record and transmit brain signals to a dedicated app. Initially, the objective is to empower individuals to manipulate a computer cursor or keyboard solely through their thoughts.
The trial is open to individuals with quadriplegia resulting from cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS). This extensive study spans six years, including 18 months of at-home and clinic visits, followed by ongoing follow-up appointments over five years. Interested candidates can register in the patient registry on Neuralink’s official website.
Notably, Elon Musk has been pursuing the goal of connecting the human brain to computers through implants for the past five years, albeit with animal testing as the primary focus until now. The company faced criticism following the death of a monkey during a project test in 2022, where the aim was to enable the primate to play Pong, one of the earliest video games.
According to author Walter Isaacson, Musk drew inspiration from science fiction authors like Iain Banks for Neuralink’s mission, envisioning a “neural lace” human-machine interface technology that could be implanted to link all thoughts directly to a computer.
In May, Neuralink announced FDA clearance for human clinical trials, with the agency officially acknowledging the approval in a statement. The launch of human trials comes just over a month after Neuralink raised $280 million in a fundraising round led by Founders Fund, a San Francisco-based venture capital firm co-founded by Peter Thiel, a controversial billionaire who was also a co-founder of PayPal.
In light of these developments, Neuralink expressed its enthusiasm for the future on X, Elon Musk’s social media platform (formerly Twitter), stating, “We’re extremely excited about this next chapter at Neuralink.”
It’s worth noting that while Musk had projected human trials at Neuralink on at least four occasions since 2019, the company did not seek FDA approval until 2022. Initially, the FDA rejected the application, citing concerns about the implant’s potential migration within the brain and the risk of 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 anticipated commencing human testing within six months. However, Reuters reported in March that employees claimed the company was rushing to market, resulting in unintended animal fatalities and a federal investigation.
As Neuralink progresses toward bringing its brain implants to a wider audience, it will need to secure regulatory approval. In 2021, the FDA released a document outlining its initial thoughts on brain-computer interface devices, acknowledging the rapid advancement in this field.
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