This week, Neuralink’s Elon Musk announced that human clinical trials have begun on his research into the Precision Robotically Implanted Brain-Computer Interface (PRIME), a medical device trail that uses a wireless, brain-computer interface to enable people with paralysis to control external devices. Designed for. their thinking.
According to Bradley Greger of Arizona State University, an associate professor of neural engineering who first talked about the potential of NeuraLink’s technology in late 2022, “this technology is going to be such a gamechanger.”
Greger has worked on vision and speech restoration using brain-computer interfaces and is currently investigating how deep brain stimulation (DBS) affects behavior in patients with movement and pain disorders.
“We’re using DBS technology to record signals from the human brain, but we only have a few channels,” says Greger. “Neuralink is using different technologies to record from the equivalent of thousands of channels.”
As a neural engineer, Professor Greger offers insights into what could come from Neuralink’s prime study.
Q: How accessible will this technology be to other researchers?
A: It’s going to be up to Neuralink. All the researchers I spoke to about Neuralink asked the same question: “When will we be able to get our hands on it?”
Q: Is Neuralink currently partnering with a research hospital?
A: They must have partnered with a major neuro-surgical center somewhere in America with this first patient study. No one knows which – they don’t want the media victimizing the hospital, the family and most importantly the patient.
Q: Do you think Neuralink will soon partner with additional neurological research institutions?
Answer: Oh, absolutely – with multiple treatment centers. I suspect that conversations and visits have been going on for a while. But potential partners are completely locked down by nondisclosure agreements as precursors to research relationships.
The partnership criteria will be to find eligible patients, but also institutions with surgical expertise and support infrastructure. There aren’t many places that meet this criteria.
If I were making the rounds for Neuralink, I’d talk to people at Stanford, UC San Francisco and Massachusetts General—places that have neurosurgical expertise and a proven track record of performing well in this kind of research.
Q: Does each of the partner organizations have to go through the FDA approval process?
Answer: Probably not. The technology and method are already FDA approved. Partners will go through an Institutional Review Board (IRB) process at their institution – each major hospital has its own IRB.
Q: Will the initial study focus only on paralyzed patients?
A. Yes. I think the first research partnership they will take on will focus on restoring movement for patients with paralysis – those with amyotrophic lateral sclerosis (ALS) or severe spinal cord injury.
Movement control is one of the things we understand most 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 usually want to work with about 10 or more patients.
Q: How long do you think before they extend the trial?
Answer: This phase of study may take one or two years.
If all goes well and the devices work as expected, and patients are healthy beyond their paralysis issues, Neuralink can move beyond feasibility trials to test safety and efficacy. For example, they could have a patient try to control a robotic arm with their mind. With Neuralink’s technology, I think you’ll see it a year from now or two or three years from now.
In the FDA’s approval process, they must specify the type of patients they will work with.
Q: If and when Neuralink moves out of the paralysis study, will they have to go through the FDA approval process again for a speech restoration study?
Answer: They must require additional IRB approval. FDA approval revolves around the device. If they move into a speech recovery study, for example, researchers may need to obtain an investigative device exemption (IDE), but this is a much simpler process than establishing device safety.
For a vision restoration trial, they will likely have to go back to the FDA for another approval because it involves brain stimulation, 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 the electricity will go into the brain instead of out of the brain. That’s what makes it stand out from the FDA’s perspective.
Q: How long do you think it will take for Neuralink’s technology to become available to the general public?
A: The technology will usually be available with a prescription from a physician or surgeon within a few years. Therefore, most of the initial users will be patients with neurological diseases. I am somewhat skeptical that healthy people would undergo neurosurgery to receive the device or be allowed surgery without some medical condition to be treated by the device.