Elon Musk’s Neuralink company, known for its experimental N1 brain-computer interface (BCI), has recently opened enrolment for its first human trial, titled Precise Robotically Implanted Brain-Computer Interface, or PRIME. This announcement comes nearly a year after the company’s latest public demonstration, slightly missing Elon Musk’s projected timeline by four months and following competitor Synchron’s entry into the market by nearly a month.
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The primary objective of the PRIME study is to evaluate the safety of Neuralink’s N1 implant and its robotic surgical system (R1). Simultaneously, it aims to assess the initial functionality of the BCI in enabling people with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) to control external devices using their thoughts. Despite Musk’s ambitious claims about transhumanistic applications, like learning skills via brain-computer interfaces, the technology indeed aspires to practical applications.
BCIs serve as a vital bridge between the human mind and machines, translating the brain’s electrical signals into digital commands. Neuralink’s N1 system employs a high-fidelity Utah Array composed of hair-thin probes. Unlike Synchron’s Stentrode, the N1 probes require installation through robotic keyhole surgery performed by Neuralink’s R1 surgical robot. Positioned on the patient’s motor cortex, these probes record and wirelessly transmit electrical impulses to a connected app, which then interprets them into actionable computer commands. Initially, the goal is to empower individuals to control computer cursors or keyboards solely through their thoughts.
Neuralink embarked on N1 system development in 2017, emerging as one of the industry’s early pioneers in the public development of commercial BCIs. However, their progress faced significant setbacks last year when the company was accused of causing suffering and death among numerous animal test subjects. These allegations led to a USDA investigation on charges of animal cruelty and the FDA’s denial of the company’s request to expedite human trials. The PRIME study operates under the FDA’s investigational device exemption (IDE), which was granted to Neuralink in May of this year.
