Elon Musk’s brain implant company Neuralink has announced it is one step closer to putting brain implants in people.
Today, the company stated that it will begin recruiting patients with paralysis to test its experimental brain implant and that it has received approval from a hospital institutional review board. Such boards are independent committees assembled to monitor biomedical research involving human subjects and flag any concerns to investigators. Neuralink is dubbing this “the Prime Study,” for Precise Robotically Implanted Brain-Computer Interface.
Neuralink did not specify where the trial will take place, and company representatives did not immediately respond to WIRED’s emailed request for an interview.
Neuralink is one of a handful of companies developing a brain-computer interface, or BCI, a system that collects brain signals, analyzes them, and translates them into commands to control an external device. In May, the company said on X, formerly Twitter, that it had received approval from the US Food and Drug Administration to conduct its first in-human clinical study, but it didn’t provide further details at the time.
In a post on its website today, Neuralink states that the initial goal of its BCI will be to “grant people the ability to control a computer cursor or keyboard using their thoughts alone.” The clinical trial will test the safety of the company’s implant and surgical robot and assess the BCI’s functionality.
Neuralink has created a patient registry for people who are interested in learning whether they may qualify for the study. In a brochure on its website, Neuralink says it is looking for participants who have quadriplegia, or paralysis in all four limbs, due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS), and are at least 22 years old. For those chosen to participate, the study will involve a combination of nine at-home and in-person clinic visits over 18 months. Neuralink anticipates the study will take six years to complete.
Neuralink’s coin-sized implant is not visible when implanted, according to the company. It records neural activity using 1,024 electrodes, distributed across 64 threads, each thinner than a human hair.
During the study, the robot will surgically place the implant into a part of the brain that controls movement intention. Once in place, the implant is designed to record and transmit brain signals wirelessly to an app that decodes movement intention.
The company has not revealed the exact region of the brain its device will be embedded in, which hospital has given the institutional review board approval, nor how many participants it will ultimately enroll in the study.
At a Neuralink “show and tell” last November, Musk spoke about two possible use cases for the implant: to help people with paralysis control tech devices and to restore vision. But there was no mention of a vision prosthetic in today’s release.
Neuralink is one of a handful of companies racing to bring a BCI to market. Although such devices have been used experimentally since the 1960s, none is available commercially. Other research efforts have allowed paralyzed people to control computers and prosthetic limbs with their thoughts, or to use a computer to speak, mostly in lab settings.
Synchron, one of Neuralink’s competitors, has shown that its implant can be used at home to allow paralyzed patients to do online banking, shopping, and emailing. The company’s implant resembles a flexible mesh stent and is threaded up through the jugular vein to sit against the brain, rather than inserted into the brain directly.
Two former Neuralink employees have started their own BCI ventures. Past Neuralink president Max Hodax established Science Corp. in 2021 to develop a prosthesis to provide artificial vision to blind people. And Benjamin Rapoport, an original member of Musk’s team, founded Precision Neuroscience in 2020. Earlier this year, the company temporarily placed its implant on the brains of three patients to test the device’s ability to read and record electrical activity.
Jacob Robinson, a professor of electrical and computer engineering at Rice University, says 18 months is longer than some previous clinical trials of brain implants. (The devices are typically taken out once a study ends.) “I think this is good news for people who will be looking to benefit from this procedure,” says Robinson, who is also CEO and co-founder of Motif Neurotech, which is developing a brain implant for treating depression. “Ideally these technologies will be functional for several years, but this is a great step in the right direction.”
Update 9-19-2023 6:25 pm ET: This story was updated to add comments from Jacob Robinson.
