Daniella Hernandez and Heather Mack report in the Wall Street Journal:
Neuralink is one of several companies trying to build neural interfaces for clinical and nonclinical applications. In recent years, neurotechnology development has been spurred by public and private investment. The goal of many of these projects is to access as many neurons as possible because that would give scientists more precise reads on activity that underpins walking, speech and mood, among other brain functions. They can then turn neural recordings into electrical signals that can be fed into a robotic device or back into the nervous system to produce movement or vision
Elon Musk and top-level scientists from his neuroscience startup Neuralink Corp., who are developing a next-generation brain-computer interface, unveiled what they billed as a significant advance toward a therapeutic device Tuesday night.
The device would connect human brains and machines with more precision than other available devices, according to the company, which has been developing the technology for roughly two years. Neuralink is putting together a submission to the U.S. Food and Drug Administration to start testing the technology in humans. The goal is to use the platform to treat neurological conditions like movement disorders, spinal-cord injury and blindness.
“It’s not like suddenly Neuralink will have this neural lace and take over people’s brain,” said Mr. Musk. He also mentioned the announcement was meant to recruit talent to the company, which has about 100 employees.
The company said it is first focusing on patients with severe neurological conditions, but wants to make it safe enough to turn the implantation surgery into an elective procedure, like Lasik.
“We hope we’re less than a year from the first safety study on the order of five patients,” said Neuralink President Max Hodak in an interview. He emphasized that it could take years before the device could help a range of patients. “The road is long,” he said.
Among the most important tests: showing they can monitor brain activity and then decode it, meaning they can correlate certain patterns of activity to actions, such as movement, vision or speech. The company didn’t specify what behavioral experiments were performed or how reliably they were able to translate brain activity into smooth, well-controlled movement.
The device has been tested on monkeys, according to Mr. Musk. The primate was able to control a computer with its brain, he said in a surprise announcement during a question and answer session. He didn’t provide any other details. A company spokeswoman confirmed the experiment had been done.
Neuralink is one of several companies, including Facebook Inc., Kernel, CTRL-Labs and Paradromics Inc., trying to build neural interfaces for clinical and nonclinical applications. In recent years, neurotechnology development has been spurred by public and private investment, including the U.S. Brain Initiative, which was started by the Obama administration in 2013.
The goal of many of these projects is to access as many neurons as possible because that would give scientists more precise reads on activity that underpins walking, speech and mood, among other brain functions. They can then turn neural recordings into electrical signals that can be fed into a robotic device or back into the nervous system to produce movement or vision to help patients, according to experts.
At the event Tuesday in San Francisco, Neuralink described a tiny probe with nearly 3,100 electrodes laid out across about 100 flexible wires, or threads, each individually inserted into rat brains by a custom-made surgical robot. The device can monitor the activity of upward of 1,000 neurons at a time, according to the company.
The sewing-machine-like robot can target very specific brain areas, helping surgeons avoid major blood vessels—an important consideration for minimizing inflammation and long-term damage, according to a paper from the company. Data were processed and analyzed by proprietary chips and software.
Neuroscientists and neurotechnologists said that a platform that can insert tiny electrodes robotically throughout the brain and then analyze activity with custom software is exciting, but cautioned it is too early to tell how quickly Neuralink’s device could safely be used in patients.
If you’re trying to walk yourself toward human prosthetics, this is a more promising direction than currently available technology,” said Tim Harris, a senior fellow at the Howard Hughes Medical Institute’s Janelia Research Campus and a developer of research-grade neural interfaces. Among the questions that are left unanswered by the company’s paper, he said, is how long it lasts in the brain.
“If you’re going to do this for people, you should be aiming for at least five years, minimum,” he said. “To do an implantation surgery of this level of intricacy, a year or two is not enough.”
The paper, which wasn’t peer-reviewed, didn’t include data on the long-term stability of recorded neural signals nor the brain’s inflammatory response.
“That is utterly critical” before any device can advance to human trials, said Loren Frank, a University of California, San Francisco neuroscientist developing brain-computer interfaces.
Neuralink has said it is doing those experiments but isn’t ready to make the data public.
The device, in theory, was designed to also stimulate brain cells, but “we have not demonstrated these capabilities here,” according to the paper. Direct brain stimulation with implanted electrodes is a longstanding approach to treating movement disorders and epilepsy. Most brain-computer interfaces are so-called open-looped systems that don’t adapt to a patient’s needs and experience. Neurosurgeons and technologists have pointed to that drawback as reason why brain stimulation hasn’t worked for treating mood disorders.
The advantage of a system like Neuralink envisions would be its ability to analyze recordings using machine learning and to adapt the type of stimulation it delivers to a patient’s brain, according to the company and other experts.
Because of Mr. Musk, Neuralink has perhaps the highest profile among startups developing brain-computer interface technology.
But in the past couple of years, nearly all startups in the sector have seen a considerable boost in investor and regulator interest. Since 2016, startups including Paradromics and CTRL Labs have collectively raised around $260 million from a mix of venture capital, grants and corporate investors. In February, the FDA released guidelines for regulating brain-computer interface technology, in hopes of spurring faster development of devices.
Dolby Family Ventures managing director David Dolby, whose firm has backed Paradromics, said as regulators are involved and more startups emerge, the time is right for the private sector to push brain-computer interface technology into the next stages of commercialization.
“There are a multitude of applications for this technology. Through open market competition, I think we will learn a lot and benefit as a society,” said Mr. Dolby.
Not all neurotech investors are convinced implantable devices are the way forward. Lux Capital co-founder and managing partner Joshua Wolfe is in investor in CTRL Labs, which is developing sensor-based technology to decode nerve signals, but said he isn’t yet comfortable with invasive devices such as those developed by Neuralink and Paradromics.
“There is no way I’m thinking about technology that involves drilling holes behind ears right now,” said Mr. Wolfe. Enke Bashllari, a neuroscientist by training who now heads venture-capital firm Arkitekt Ventures, agreed there are considerable safety measures that must be ensured with implantable technology and said she believes that noninvasive devices also have a valuable role to play in augmenting human movement or cognitive performance. But she said the highest unmet medical needs will require technology that goes inside.
“It has to allow for two main things—high spatial resolution and high bandwidth. It has to interface with millions of neurons at the same time and you need to know exactly which neuron is firing,” she said. “That can currently only be done invasively.”
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