Musk's Neuralink can now start human trials of brain implant technology
Aims to let people control mice and keyboards with their thoughts
Elon Musk's controversial biotech startup Neuralink has obtained authorisation to start recruiting for its first human trials.
"We are happy to announce that we've received approval from the reviewing independent institutional review board and our first hospital site to begin recruitment for our first-in-human clinical trial," the company said in a blog post on Tuesday.
Founded in 2016, Neuralink is among the companies trying to develop a brain-computer interface (BCIs) that can collect and analyse brain signals.
The company's brain implant is intended to let people control a computer mouse or keyboard using their thoughts. It would be inserted in the brain region responsible for controlling the intent to initiate movement.
Musk has previously said these chips could ultimately help people dealing with conditions such as autism, depression, schizophrenia and obesity.
Following clearance from an independent review board, Neuralink is now gearing up to provide brain implants to patients grappling with quadriplegia, as part of the six-year long PRIME Study (P recise R obotically Im planted Brain-Computer Interfac e).
Individuals suffering quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) can take part in the study, which involves 18 months of at-home and clinic visits, followed by follow-up appointments over five years.
Patients in the trial will undergo surgery to implant a chip in their brain. The chip will be surgically placed by a robot and will subsequently record and transmit brain signals to a dedicated app.
The study will assess the safety and effectiveness of the technology.
In May, Neuralink announced it had obtained clearance from the Food and Drug Administration (FDA) to conduct its first clinical trial in humans.
Initially, the company had aimed to secure approval for implanting its device in 10 patients. However, it later engaged in negotiations with the FDA to reduce the number of patients, responding to the agency's heightened safety concerns.
The specific number of patients ultimately approved remains undisclosed.
Up until now Neuralink has conducted its tests on animals. Notably, there have been demonstrations involving a monkey equipped with Neuralink's brain-computer interface learning to type messages and another playing ping pong.
Additionally, a pig was shown running on a treadmill.
Although the demonstrations have been deemed successful, the animal trials have faced scrutiny and criticism, with allegations of unnecessary suffering inflicted during the experiments.
Former employees have described the tests as "hack jobs," with some revealing to Reuters that there was an instance where the device was incorrectly implanted in pigs, resulting in the need for euthanasia.
Even if the BCI device proves to be safe for human use, experts suggest that it could still take over a decade for the startup to obtain regulatory clearance for commercial use.