Neuralink, Elon Musk’s company developing brain chips, has started recruiting for human trials, after being granted approval by the US Food and Drug Administration (FDA) in May 2023.
1. Human trials
In an announcement form 19 September, Neuralink has revealed its “first-in-human” clinical trial is open for recruitment, specifying that those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.
The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) – an investigational medical device trial for an implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of Neuralinks’s implant (N1) and surgical robot (R1) and assess the initial functionality of the BCI for enabling people with paralysis to control external devices with their thoughts, the company explained.
“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. 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 BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone”, the company said.
The ultimate goal of the new technology is, according to its developers, to eradicate problems such as autism, depression and schizophrenia, as well as helping people with amputated limbs or spinal injuries to control prostheses or computers with their thoughts and volition.
2. Safety concerns
A 2022 report by the Physicians Committee for Responsible Medicine (PCRM) in the US accused Musk’s company of subjecting its test animals to “extreme suffering.” According to the organization, 15 of the 23 monkeys in the tests either died or had to be euthanised during the testing of the implants. The FDA approval went ahead despite these concerns, Musk recently replying to an X user that the monkey they used for the animal trials were “close to death already”.
Since the approval for human trials however, the PCRM has submitted a complaint to the US Securities Exchange Commission (SEC) for securities fraud. According to the Committee’s letter to the SEC, Neuralink is lying to investors about the safety, and thus marketability, of the implant.
“Musk knows that [no monkey has died as a result of the implant] to be false. Public records obtained by the Physicians Committee reveal that at least 12 young, previously healthy monkeys were euthanized by Neuralink as a direct result of problems with the company’s implant. The animals’ deaths and the reasons for their deaths relate directly to the safety and marketability of the brain-computer interface Neuralink is developing, and thus it is critical that the company provide investors with factually accurate information.”
A former Neuralink employee confirmed for Wired that the monkeys used in the trial were indeed young and healthy. Moreover, they had to go through a one year of behavioural training specifically to ensure the primates were not close to death. The former employee called Musk’s allegations about the monkeys being terminal “ridiculous”, if not a “straight fabrication”.
Moreover, Wired has obtained veterinary reports describing the effects of the implants on the animals. “The complications include bloody diarrhoea, partial paralysis, and cerebral edema, a condition colloquially known as brain swelling”, Wired cites the vet records.
One of the subjects, “Animal 20“, scratched at the site of the implant until it bled and ultimately dislodging the device. “Animal 15” was observed picking at the implant until it bled, as well as pressing its head against the floor, a sign of pain or infection. The monkey had got so fearful of the staff that it started shaking “only when doors open and new personnel walk in the room – thought to be a stress response”. To try and comfort itself, the female monkey was noticed laying on the cage’s floor, holding hands and grooming its roommate.
