Neuralink, founded by billionaire Elon Musk, received permission for the first clinical trials with a brain implant in humans in May and is now recruiting the first volunteers. The study, which will last approximately six years, involves implanting a brain-computer interface (BCI) into the region of the human brain responsible for movement using the surgical robot R1. The original goal of the project is to give people the ability to control the cursor or computer keyboard using the power of their thoughts.
Image source: Neuralink
Yesterday, Neuralink announced that it had received approval from an independent ethics review board to begin enrolling participants in the first clinical trial of its brain implant for paraplegic patients. The study, called PRIME (Precise Robotically Implanted Brain-Computer Interface), aims to evaluate the safety of the N1 implant and the R1 surgical robot as well as the functionality of the BCI.
The N1 implant records neuronal activity using 1024 electrodes distributed across 64 filaments. These ultra-flexible and ultra-thin threads minimize damage during implantation and subsequent use.
In May of this year, Neuralink received the green light from the US Food and Drug Administration (FDA) to begin its first human clinical trials. It is noteworthy that at this point the company was already under strict regulatory supervision in connection with animal testing.
Candidates include people suffering from paralysis due to cervical spine injury or amyotrophic lateral sclerosis. However, the company did not disclose how many people will be recruited to take part in the study, which will last approximately six years. The company had previously planned to enroll 10 patients, but the FDA proposed reducing that number due to concerns about the study’s safety.
The head of the R1 surgical robot integrates optical systems and sensors, including 5 cameras, as well as optical coherence tomography (OCT) devices.
The study will use the surgical robot R1 to surgically implant a BCI into the region of the brain responsible for generating movement intention. The N1 implant, which is cosmetically undetectable once installed, is designed to wirelessly transmit brain signals to an app that demonstrates movement intentions. Neuralink’s original goal is to be able to control a computer cursor or keyboard using only the power of human thought.
A needle thinner than a human hair captures, inserts, and releases nerve fibers
Musk sees big opportunities for Neuralink, including rapid surgical interventions using the chips to treat obesity, autism, depression and schizophrenia.
Despite recent advances, experts warn that even if a BCI device is proven safe for human use, approval for commercial use could take more than a decade. This is due to the need to strictly adhere to the safety standards set by the FDA.
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