2024-02-03 05:30:00
This week, Elon Musk of the Neuralink company announced that clinical trials on humans have begun in the Precise Robotically Implanted Brain-Computer Interface (PRIME) study, a medical device track that uses a wireless brain-computer interface designed to allow people with paralysis to control external devices with their thoughts.
According to Arizona State University’s Bradley Greger, an associate professor of neural engineering who first commented on the feasibility of Neuralink technology in late 2022, “this technology is going to be such a game changer.”
Greger has worked on restoring vision and speech through brain-computer interfaces, and is currently researching how deep brain stimulation (DBS) treats patients with movement disorders and pain.
“We use DBS technology to record signals from the human brain, but we only have a few channels,” Greger said. “Neuralink uses a different technology to record than the equivalent of thousands of channels.”
As a neuroengineer, Professor Greger offers his insights into what may come from Neuralink’s PRIME research.
Question: How accessible will this technology be to other researchers?
Answer: It will depend on Neuralink. Every researcher I’ve ever talked to about Neuralink has asked the same question: “When can we get our hands on it?”
Q: Does Neuralink collaborate with a research hospital?
A: They definitely partnered with a major neurosurgical center somewhere in America with this first patient study. No one knows which one – they don’t want the media to haunt the hospital, the family and most importantly, the patient.
Q: Do you think Neuralink will soon partner with other neurological research institutions?
A: Oh, definitely – with several medical centers. I suspect talks and visits have been going on for some time. But potential partners are completely locked out by confidentiality agreements as a precursor to a research relationship.
The criteria for partnership will be finding suitable patients, but also institutions with surgical skill and support infrastructure. There are not many places that meet these criteria.
If I were doing the rounds for Neuralink, I would talk to the people at Stanford, the University of San Francisco, and Massachusetts General—the places that have neurosurgical expertise and have a proven track record of doing well in this kind of research.
Q: Will each of the partner institutions have to go through the FDA approval process?
A: Probably not. The technology and procedures are already approved by the FDA. The partners will go through an institutional review process (IRB) at their institutions – each large hospital has its own IRB.
Q: Will the initial study focus exclusively on paralyzed patients?
A: Yes. I think the research partnerships that will be taken first will focus on restoring movement for those with paralysis—patients who have amyotrophic lateral sclerosis (ALS) or severe spinal cord lesions.
Controlling movement is one of the things we understand best about the brain, so I’d say it’s the easiest goal to start with.
I haven’t seen the actual protocol, but for this type of study you’ll typically want to work with about 10 or so patients.
Q: How long do you think it will take until they expand the trial?
A: This phase of the research will probably last about one or two years.
If all goes well and the devices work as expected, and the patients are healthy beyond their paralysis issues, Neuralink may move beyond feasibility trials to testing safety and efficacy. For example, a patient might try to control robotic arms with their minds. With Neuralink’s technology, I think you can see it a year from now, or from the outside, two or three years.
In the FDA approval process, they must specify the type of patients they will work with.
Q: If and when Neuralink moves beyond paralysis studies, will they have to go through the FDA approval process again for speech restoration research?
A: They will definitely need additional IRB approvals. FDA approvals revolve around the device. If they’re moving into speech reconstruction research, for example, researchers may need to get an investigational device exemption (IDE), but that’s a much simpler process than establishing the safety of the device itself.
For the vision restoration trial, they will likely have to go back to the FDA for further approval because it involves stimulating the brain, which is quite different from this study. They’ve probably been working on a vision protocol in the background for years.
Although the vision restoration will use the same technology, the same wiring and the same device, it will be implanted in a different location and will involve electricity going into the brain and not out of the brain. That’s what might make it different from the FDA’s perspective.
Q: How long do you think it will take for Neuralink’s technology to actually be available to the general public?
A: The technology may be generally available with a doctor’s or surgeon’s prescription in a few years. Therefore, most initial users will be patients with neurological disorders. I’m a little skeptical that healthy people would undergo neurosurgery to get the device or that the surgery would be possible without some medical condition being treated by the device.
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