Elon Musk's Neuralink Launches PRIME Study: First Human Clinical Trials for Brain-Computer Interface Starting Soon

Quincy Jon, Tech Times 20 September 2023, 12:09 pm

Neuralink, Elon Musk's neurotech startup, said on Tuesday that it would begin patient recruitment for its pioneering first-in-human clinical study, the PRIME Study.

The noteworthy announcement comes after Neuralink recently achieved the milestone of receiving permission from a hospital site and an independent institutional review board, as reported by CNBC. In May, the firm also received regulatory approval from the Food and Drug Administration (FDA), which was a significant step in the direction of commercializing neural interface technology.

Here's What Will Happen in Neuralink's PRIME Study

Participants in the PRIME Study will have to go through invasive brain surgery, which is an important step in Neuralink's path. Neuralink is developing a cutting-edge brain implant that will empower people with severe paralysis by allowing them to control external devices via neural impulses.

According to the firm's blog, the initial aim of Neuralink's brain-computer interface "is to grant people the ability to control a computer cursor or keyboard using their thoughts alone."

This groundbreaking experiment may involve cervical spinal cord injury and ALS patients, as per Firstpost. Although the company does not specify the number of participants, the trial is planned to continue for six years. Robots will assist in the implantation of brain-computer interface (BCI) devices throughout the course of the study.

Notably, Neuralink originally requested FDA clearance to implant its BCI in 10 patients, but according to current and former employees, discussions with the FDA led to a reduced, undisclosed number of permitted patients due to safety concerns, as per a Reuters report.

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Tech mogul Elon Musk has outlined grandiose plans for Neuralink, including quick surgical implantations of chip devices to cure disorders including obesity, autism, melancholy, and schizophrenia. However, despite the game-changing potential, experts predict that it may still take more than 10 years for Neuralink to get commercial certification, even if the BCI device is shown to be safe for human usage.

Neuralink Controversies

Neuralink's statement comes against the backdrop of persistent criticism of the firm's earlier use of animal experimentation. In one incident, the device was purportedly inserted wrongly in pigs, resulting in death, and reports surfaced claiming that animal studies caused unnecessary pain; former staff referred to these trials as "hack jobs," according to a report from The Guardian.

These accusations against Elon Musk's company have sparked several investigations, including examinations into animal welfare by the Department of Agriculture and the transfer of biohazardous chemicals over state boundaries by the Department of Transportation.

Neuralink has not yet revealed the precise location, start date, or total number of participants for the upcoming clinical study. If the BCI device is shown to be safe, it is predicted that the road to universal patient access will be long and take multiple decades.