Neuralink's looking for participants willing to be part of human trials

Musk company gets FDA's OK for six-year assessment of its brain implants

That was fast: Neuralink, Elon Musk's brain-computer interface implant company, only received Food and Drug Administration (FDA) approval for human tests in late May, but it's already looking for participants in its first six-year trial program.

Then again, Neuralink has been promising human trials of its implant, which is designed to relay brain signals to a computer or smartphone to allow a person to control a device with their thoughts, for years. Given Musk's repeated promises, and prior failure to earn FDA approval, the company had plenty of time to get their testing infrastructure in place before finally earning FDA approval for human trials earlier this year.

Now, however, a visit to the Neuralink website shows off a new look including a link to a patient registry where those with enough faith in Musk's company to not seriously maim or injure them in the implantation process or afterward can sign up.

Per a study brochure [PDF], Neuralink is seeking an unspecified number of participants for its Precise Robotically Implanted Brain-Computer Interface (PRIME) study. The company is specifically looking for quadriplegics "interested in exploring new ways of controlling [their] computer" who are at least 22 years old and have a consistent and reliable caregiver.

The study itself will be pretty intense, with nine at-home and in-person clinic visits over 18 months, followed by five years of follow-ups. Participants will also have to do a minimum of two weekly brain-computer interface research sessions for one hour.

Participants shouldn't expect much in the way of compensation either – only study-related costs like travel expenses to and from test sites are being covered by Neuralink.

Do you want this thing in your head, Elon?

Those chosen for the PRIME study will be implanted with a coin-sized N1 chip, with its inductive rechargeable battery and network of 1,024 electrodes distributed across 64 threads that are embedded directly into the brain's gray matter.

But it's not clear from Neuralink's website how much the N1 has changed since the FDA raised its initial complaints in early 2022, when the company first sought approval for human tests. We asked Neuralink about the N1's evolution, but didn't immediately hear back.

What the FDA told Musk's brain chip company it was worried about is concerning. The feds weren't sure the implants could be removed without causing permanent brain damage; they weren't sure they wanted to allow a lithium-ion battery to be implanted in a human skull; there were fears the wires could "migrate" to different areas of the brain; and the chips had reportedly been overheating too – which would make for an unpleasant headache.

While the FDA told us it won't comment on questions related to human trial approval, it did tell us that Neuralink "provided sufficient information to support the approval of its [initial design exemption] application to begin human trials under the criteria and requirements of the [exemption] approval."

As we've reported previously, around two-thirds of human trial devices pass the FDA's approval process on their first go, while around 85 percent pass on their second attempt.

In addition to questions of human suitability, Neuralink has also faced accusations of animal cruelty when chip implant surgeries caused infections and death in monkeys. The company has also been accused of mishandling implants removed from dead animals that were infected with dangerous pathogens.

Both the animal welfare concerns and pathogen transportation issues were raised by the Physicians Committee of Responsible Medicine (PCRM), which has been voicing concerns about Neuralink for some time.

"It is important to remember that such FDA approval is not an acquittal of Neuralink's well-documented track record of animal cruelty and sloppy scientific studies," the PCRM said. "The public should continue to be skeptical of the safety and functionality of any device produced by Neuralink."

While Neuralink is only now seeking human trials, other brain-computer interface research has breezed past Musk's company. In May, a paper revealed how researchers in Switzerland developed a system that allowed a paraplegic man to regain the use of his legs, enabling him to walk and even climb stairs.

Last month, boffins at UC San Francisco used neural implants in a woman paralyzed by a brain stem stroke to allow her to speak through a digital avatar trained to translate her brain waves into speech.

Neuralink, meanwhile, will be presumably beginning its tests soon, but exactly when is anyone's guess – this is an Elon Musk operation after all. Speaking of the world's sometimes richest man, we've also inquired with Neuralink whether Elon is willing to put himself under the robotic knife for science, and will let you know if it decides to respond. ®

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