Neuralink is moving to human trials for its brain-implant tech

20 Sep 2023

Image: © piter2121/Stock.adobe.com

The controversial company received FDA approval to conduct human trials earlier this year and recently raised $280m.

Neuralink, the brain-implant company founded by Elon Musk, is looking for candidates to take part in a human clinical study.

The company claims to have received approval from an ”independent institutional review board” to conduct its first human clinical trials. Nerualink is looking for people who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) to participate in the six-year study.

The initial goal is to give people the ability to control a computer cursor or keyboard using their thoughts, by surgically inserting a brain-computer interface. The trial is also being conducted to evaluate the safety of the implant – called N1 – and the company’s surgical robot, R1.

The company said this study represents an important step to create a generalised brain interface that can “restore autonomy to those with unmet medical needs”.

“During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention,” Neuralink said in a blogpost. “Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention.”

In May, Neuralink received approval from the US Food and Drug Administration (FDA) to run clinical trials on humans, in the form of an investigational device exemption. This allows devices to be used in a clinical study in order to collect “safety and effectiveness data”.

Last month, Neuralink raised $280m in a Series D funding round led by Founders Fund, the VC firm co-founded by billionaire tech investor and PayPal co-founder Peter Thiel.

A history of controversy

Neuralink was founded in 2016 by Musk along with experts in neuroscience and robotics. The San-Francisco-headquartered company is one of many working to advance the field of brain-computer interface technology.

The company has trialled the technology with pigs and monkeys over the years, with one monkey making headlines when it was shown playing the classic video game Pong with its mind via two N1 Link chips embedded in its brain.

But like many companies associated with Musk, Neuralink has been hit with controversy in the past. The company faced federal investigation in the US for potential animal welfare violations during its trials.

Reuters report last December based on records and sources with direct knowledge of the company’s animal-testing operations found that Neuralink had killed about 1,500 animals, including more than 280 sheep, pigs and monkeys.

The investigation followed internal staff complaints around how the company was allegedly rushing its animal testing, resulting in botched experiments. Neuralink denied these claims earlier this year.

In February, the US Department of Transportation said it was investigating Neuralink for potentially moving hazardous pathogens, Reuters reported. An animal welfare group claimed implants removed from the brains of monkeys were being moved in an unsafe way and that these implants could contain infectious diseases.

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Leigh Mc Gowran is a journalist with Silicon Republic

editorial@siliconrepublic.com