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  ARM Give a man a fire and he's warm for a day, but set fire to him and he's warm for the rest of his life (Terry Pratchett, Jingo)

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

(2023/09/20)


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 [1]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, [2]for years . Given Musk's repeated promises, and [3]prior failure to earn FDA approval, the company had plenty of time to get their testing infrastructure in place before finally earning FDA [4]approval for human trials earlier this year.

Now, however, a visit to the [5]Neuralink website shows off a new look including a link to a [6]patient registry where those with enough faith in Musk's company to not seriously [7]maim or injure them in the implantation process or afterward can sign up.

[8]

Per a study [9]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.

[10]

[11]

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 [12]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.

[13]Neuralink says US OK's human experiments with Elon's brain chips

[14]Is Neuralink ready for human brain implants? Allegedly so

[15]Funnily enough, FDA forbids Elon Musk's Neuralink human experiments

[16]Elon Musk's Neuralink probed over pathogen transport

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."

[17]

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 [18]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.

[19]

"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 [20]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 [21]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 [22]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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[1] https://www.theregister.com/2023/03/27/neuralink_human_brain_trial/

[2] https://www.theregister.com/2022/12/02/neuralink_ai_brain_chip/

[3] https://www.theregister.com/2023/03/02/neuralink_fda_rejection/

[4] https://www.theregister.com/2023/05/26/neuralink_brain_implant_fda/

[5] https://neuralink.com/

[6] https://neuralink.com/patient-registry/

[7] https://www.theregister.com/2022/12/07/neuralink_investigation_animals/

[8] https://pubads.g.doubleclick.net/gampad/jump?co=1&iu=/6978/reg_offbeat/science&sz=300x50%7C300x100%7C300x250%7C300x251%7C300x252%7C300x600%7C300x601&tile=2&c=2ZQtrhElE8pEjAHplsiCXBgAAA5c&t=ct%3Dns%26unitnum%3D2%26raptor%3Dcondor%26pos%3Dtop%26test%3D0

[9] https://neuralink.com/pdfs/PRIME-Study-Brochure.pdf

[10] https://pubads.g.doubleclick.net/gampad/jump?co=1&iu=/6978/reg_offbeat/science&sz=300x50%7C300x100%7C300x250%7C300x251%7C300x252%7C300x600%7C300x601&tile=4&c=44ZQtrhElE8pEjAHplsiCXBgAAA5c&t=ct%3Dns%26unitnum%3D4%26raptor%3Dfalcon%26pos%3Dmid%26test%3D0

[11] https://pubads.g.doubleclick.net/gampad/jump?co=1&iu=/6978/reg_offbeat/science&sz=300x50%7C300x100%7C300x250%7C300x251%7C300x252%7C300x600%7C300x601&tile=3&c=33ZQtrhElE8pEjAHplsiCXBgAAA5c&t=ct%3Dns%26unitnum%3D3%26raptor%3Deagle%26pos%3Dmid%26test%3D0

[12] https://www.theregister.com/2023/03/27/neuralink_human_brain_trial/

[13] https://www.theregister.com/2023/05/26/neuralink_brain_implant_fda/

[14] https://www.theregister.com/2023/03/27/neuralink_human_brain_trial/

[15] https://www.theregister.com/2023/03/02/neuralink_fda_rejection/

[16] https://www.theregister.com/2023/02/10/dot_investigating_neuralink/

[17] https://pubads.g.doubleclick.net/gampad/jump?co=1&iu=/6978/reg_offbeat/science&sz=300x50%7C300x100%7C300x250%7C300x251%7C300x252%7C300x600%7C300x601&tile=4&c=44ZQtrhElE8pEjAHplsiCXBgAAA5c&t=ct%3Dns%26unitnum%3D4%26raptor%3Dfalcon%26pos%3Dmid%26test%3D0

[18] https://www.theregister.com/2022/12/07/neuralink_investigation_animals/

[19] https://pubads.g.doubleclick.net/gampad/jump?co=1&iu=/6978/reg_offbeat/science&sz=300x50%7C300x100%7C300x250%7C300x251%7C300x252%7C300x600%7C300x601&tile=3&c=33ZQtrhElE8pEjAHplsiCXBgAAA5c&t=ct%3Dns%26unitnum%3D3%26raptor%3Deagle%26pos%3Dmid%26test%3D0

[20] https://www.pcrm.org/news/news-releases/physicians-committees-statement-neuralink-reportedly-receiving-approval-human

[21] https://www.theregister.com/2023/05/26/experimental_brain_spine_interface/

[22] https://www.theregister.com/2023/08/28/ai_in_brief/

[23] https://whitepapers.theregister.com/



Doctor Syntax

If self-experimentation was good enough for Neil Noakes it should be good enough for Elon Musk.

I can't believe I am going to type this

Lis

But cut the fucking snark!

I remember the snark about Space X when it started up. But thanks to Melon Suk putting someone else in charge look where it is now.

So it is easy to take piss out of neurolink turning people into cabbages. But...

If Melon puts someone else in charge, is it just possible that some good could come out of this?

I am about to go for treatment for cancer for the 4th time. This time the treatment is experimental. I don't give a fuck. Just do it to me.

Maybe people who are desperate, like me, will be happy to give Neurolink a go?

All medical science that we now take for granted was developed from awful happenings.

Re: I can't believe I am going to type this

IGotOut

So you skipped over all the parts where they cut corners, side stepped regulations, killing and maiming animals in the process.

The rules are there for a reason. If a medical company ignore these, then I sure as hell wouldn't trust them.

Re: I can't believe I am going to type this

aerogems

He didn't really have a choice but to put Shotwell in charge at SpaceX. Moron decided it'd be a good idea to let himself be filmed smoking a blunt. We can talk about the stupidity of marijuana being a Schedule 1 drug in the US among the ranks of heroin and cocaine, but it doesn't change the fact that it is so classified, and that possessing and smoking it is a federal crime. A federal crime Twitler decided to have himself filmed committing while holding a US Security Clearance.

Condolences on your cancer. Since you read El Reg you can't be THAT bad a person. If there are people in a similar position who are willing to sign up for Twitler's program, I salute their willingness to sacrifice for the potential benefit for the rest of us. However, when it comes to Neurolink, I suspect their sacrifice would be wasted. There are others who have been at this game a lot longer than Twitler and they haven't managed devices that are orders of magnitude less complex than what Twitler's attempting. I'd much rather see volunteers sign up for clinical trials with those outfits. It has nothing to do with Twitler being a raging arsehole, and more to do with the fact that a lot of really smart people have been working on this a long time and they haven't managed to crack it yet, so the idea that Twitler can just throw a bunch of money around and magically achieve the equivalent of cold fusion in his garage, is rather bonkers.

Maybe Musk already had this done

DS999

And that's why he's gone off the deep end in the last couple years?

Re: Maybe Musk already had this done

Anonymous Coward

Beat me to it, but yeah, when was the last time you saw a 360 degree of his head?

I don't expect this one to end well, let alone in success. But since SpaceX is killing it, it will take it's place on his late phase Howard Huges dumpster fire reel.

This era will be hard to explain 20 years from now.

I'd fancy that implant

Andy Non

about as much as a hole in the head. Folks having it must want their heads examining.

Re: I'd fancy that implant

Clausewitz4.0

They are already doing it illegally and destroying people's lives.

If you were the subject of such an illegal experiment, I suggest you grab your purse and demand your BILLION.

darkrookie28

This is like a scam to take advantage of the disabled.

Go to the site. Nothing on how the thing interfaces with the computer on the main page. Nothing on price. Just some picture of a phone on what looks to be a wireless charger. And a whole bunch of how this will help the less fortunate.

Seems fishy to me.

*Hard* Pass

aerogems

I cannot stress just how hard of a pass that would be for me. After reading about how many research animals they had to put down as a result of massive infections because of the abattoir conditions of their lab, and how they were transporting biohazardous waste around without proper safeguards.. even if Twitler offered me his entire fortune, I'd tell him where he can stuff it. What good is all that money if I'm a drooling vegetable the rest of my life? Or worse, being completely lucid, but trapped in my meat sack body.

genius, n.:
Person clever enough to be born in the right place at the right
time of the right sex and to follow up this advantage by saying
all the right things to all the right people.