Neuralink — Elon Musk’s neurotechnology startup company — announced on Tuesday that recruitment is open to implant a wireless brain-computer interface in its first in-human clinical trial.
Company officials describe the PRIME Study — short for Precise Robotically Implanted Brain-Computer Interface — as a groundbreaking investigational medical device trial designed to evaluate the safety and assess the functionality of an implant and surgical robot for people with severe degenerative diseases, such as amyotrophic lateral sclerosis (ALS), to control external devices with their thoughts.
“During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention,” the company announced. “Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention.”
“The initial goal of our [Brain-Computer Interface] is to grant people the ability to control a computer cursor or keyboard using their thoughts alone,” the company added.
Applicants with quadriplegia due to cervical spinal cord injury or ALS may qualify for the trial, officials said.
Musk has touted that over the years, the experimental brain-chip implant could treat neurological disorders such as paralysis and blindness by bridging signals between existing neurons and allowing humans to save and replay memories, saying that “the future is going to be weird.”
Musk reportedly said at a “show and tell” recruitment event late last year that he would likely implant himself with the neurotechnology.
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“You could have a Neuralink device implanted right now, and you wouldn’t even know,” Musk said at the time. “In fact, in one of these demos, I will.”
The company received approval from the U.S. Food and Drug Administration (FDA) in May to launch its first-in-human clinical study.
Neuralink received FDA breakthrough designation for its technology three years ago, and Musk repeatedly claimed that human trials would begin immediately. However, the company had its application rejected in early 2022 by the FDA over safety concerns.
Seven current and former FDA employees told Reuters earlier this year that the agency’s major safety concerns involved “the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.”
“We want to be extremely careful and certain that it will work well before putting a device into a human,” Musk said, according to Reuters. “The progress at first, particularly as it applies to humans, will seem perhaps agonizingly slow, but we are doing all of the things to bring it to scale in parallel. So, in theory, progress should be exponential.”
The approval comes as U.S. lawmakers requested that regulators investigate how the company has conducted animal testing and if those trials were rushed or resulted in failed experiments.
Neuralink has also faced other federal investigations, including from the USDA’s Inspector General over concerns of violating the Animal Welfare Act and the U.S. Department of Transportation over accusations over the movement of hazardous pathogens.