Elon Musk’s brain-machine interface company Neuralink intends to put its first implant in a human subject in the next six months, he said last week, having thus far only tested the technology on animals.
Musk said the company has been “working hard to be ready for our first human”, and has submitted most of the required paperwork to the US Food and Drug Administration to launch a study in humans, reports STAT News.
The company, which is designing a device to translate the brain’s signals into actions, also announced it will first focus specifically on two applications: restoring human vision, and helping people who can’t move their muscles to control devices like smartphones or even return the ability to move to people with severed spinal cords, Musk said.
Though it’s starting with certain parts of the brain, Musk said Neuralink’s long-term goal is to create a system that can translate impulses from the entire brain into actions.
“As miraculous as it may sound, we’re confident it is possible to restore full body functionality to someone who has a severed spinal cord,” he said.
Human trials would be a significant milestone for Neuralink, which was incorporated in 2016 and has so far only tested its technology in animals. Still, it’s not clear if they’ll be able to hit the six-month timeline to begin human studies.
And even if the company’s trial is given a green light, there would still be a long and uncertain path to achieve the company’s first two primary goals.
Musk has called on people from a diverse set of industries to consider joining Neuralink to make that possible.
“When you break down the skills needed to make Neuralink work, it’s actually many of the same skills that are required to make a smartwatch or modern phone work,” he said, such as software, batteries, and radios technology.
“Prototypes are easy, production is hard,” he said.
DJ Seo, the vice-president of implant at Neuralink, said the company has been working closely with the FDA as it develops its approach, which involves using a surgical robot developed by the company that implants the device in a short procedure.
In 2020, Musk announced that the agency had granted Neuralink a breakthrough device designation, and the billionaire expressed confidence that its brain implant would soon be tested in a clinical trial for people with severe spinal cord injuries.
But that goal keeps getting pushed back. Early this year, the company posted a job listing for a clinical trial director who would work with “Neuralink’s first clinical trial participants”, and the company currently has a job opening for a clinical research coordinator – but the trial has not yet been approved by the FDA.
In the meantime, other companies developing brain-computer interfaces are surging ahead with their work.
One, Blackrock Neurotech, was propelling research in the field long before Neuralink had even launched, and is now awaiting the FDA’s approval of its commercial BCI.
Another company, Synchron, also has a breakthrough device designation, and it has started implanting electrodes into patients for its early feasibility study. And two more companies are aiming for their first human tests in 2023: Paradromics and Precision Neuroscience, which was co-founded by one of Neuralink’s founding members, Benjamin Rapoport.
Neuralink’s slow progress toward human trials hasn’t kept it from growing, though. In July 2021, the company raised another $205m in funding, far exceeding the money flowing into other BCI firms. It currently has more than 60 open positions listed on its website, from neural engineering to software and research services to surgery and robotics.
A high-profile company like Neuralink could bring more attention to brain-computer interface research more broadly, some experts say. And while brain-to-text technology isn’t new, and has been demonstrated among people with paralysis over the past several years, noted Sam Nason-Tomaszewski, a postdoctoral researcher at Emory who studies brain-computer interfaces, he said Neuralink could be the first to wirelessly conduct the process using an implantable device.
In the company’s last demonstration, in April 2021, it showed a macaque playing the computer game Pong using two Neuralink implants. By reading the signals picked up from more than 2 000 electrodes while the monkey used a joystick to play the game, a software “decoder” learned to convert its brain activity into intended movements without the use of his hands – the same feat accomplished by BCI pioneer Matt Nagle in the early 2000s. Since then, the company has faced scrutiny for its treatment of the macaques used in its studies.
At last week’s event, the company emphasised the precautions it takes in testing its technology in animals. Neuralink also offered updates on a range of other features and technical challenges, including updated charging systems for the implantable devices, internal software and hardware testing processes, and efforts to build a synthetic model in which to test implants and the procedure to place them.
Musk said the company planned to make some of its tools, including surgical robots and implantable devices, available to neuroscience researchers at universities and hospitals.
Asked whether the company would make the data it has collected publicly available, Musk said he’d “have no problem with just publishing it on our website – you can use it if you want”.
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