This Neuralink marketing image shows its coin-sized brain-computer interface separated into parts.
Neuralink says its brain-computer interface is fully implantable, cosmetically invisible, and designed to let a person control a computer or mobile device anywhere they go. [Image courtesy of Neuralink]

Neuralink, the Elon Musk-backed brain-computer interface (BCI) maker, today announced that it opened recruitment for a clinical trial.

The first-in-human trial — the PRIME study — evaluates the company’s fully implantable, wireless BCI and delivering surgical robot. It assesses the initial functionality of the BCI for enabling people with paralysis to control external devices with their thoughts.

According to a blog post on Neuralink’s website, people who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.

Neuralink’s N1 brain implant comes in at about the size of a coin. Remotely rechargeable, the implant goes along with electrode-laced threads that go further into the brain. Neuralink also has an R1 robot meant to be programmed to implant the BCI system while avoiding vasculature. The company designed its system to enable the user to control a computer or mobile device anywhere they go.

During the study, R1 will surgically place the N1’s threads in a region of the brain that controls motion intention. Once placed, N1 remains cosmetically invisible while recording and transmitting brain signals wirelessly to an app. The app decodes movement intention to give people the ability to control a computer cursor or keyboard using their thoughts.

More about Neuralink’s road to this study

Neuralink is conducting its PRIME study under FDA investigational device exemption, garnered in May of this year.

Musk previously tipped Neuralink to file for FDA approval for human trials in 2020, but the company failed to meet that initial goal. In 2022, Neuralink and the University of California, Davis, faced accusations of “egregious violations of the Animal Welfare Act” by the Physicians Committee for Responsible Medicine (PCRM). They cited documents obtained through a public records lawsuit. The allegations claimed that Neuralink caused extreme suffering in monkeys.

Earlier this month, Musk posted on X (formerly Twitter) that no monkey died of a Neuralink implant. He said to minimize risk, the company “chose terminal monkeys (close to death already).”

Musk said near the end of last year that the company planned for a first-in-human implant within the next six months. Shortly after a “show-and-tell” event, Neuarlink reportedly faced a U.S. Department of Agriculture Inspector General animal welfare investigation.

However, the company finally got the FDA’s go-ahead for a first-in-human implant in May. It achieved another milestone last month when it raised $280 million in a Series D funding round.

Keeping up-to-date with BCIs

Neuralink continues to make headway in the BCI space while a number of companies also bring innovative technologies to the table.

Synchron develops the catheter-delivered Stentrode BCI implant, another innovative BCI offering. Company officials say they represent the only BCI company tapping into blood vessels to capture signals from the brain. The company has the backing of Bill Gates and Jeff Bezos. Earlier this month, it completed enrollment in its own FDA IDE trial, potentially establishing the upper-hand on Neuralink.

Blackrock Neurotech, another competitor, develops the Utah Array. They’ve implanted it in patients since 2004 through research studies, with zero FDA-reported serious adverse events. It also unveiled a next-gen BCI that comes in thinner than an eyelash, almost in the form of a thin piece of lace.

Precision Neuro, co-created by a founding member of Elon Musk’s Neuralink BCI venture, has been developing its BCI since 2021. Benjamin Rapoport, a former part of the Neuralink effort, started the company with private equity investor Michael Mager. The company completed the first-in-human procedures for a pilot clinical study of its neural implant system.

Just today, InBrain announced that it received FDA breakthrough device designation for its intelligent network modulation system. The semiconductor-derived brain-computer interface (BCI) technology could decode and modulate brain activity. It uses AI to trigger adaptive responses for personalized neurological treatment. In addition to Parkinson’s InBrain notes epilepsy and speech impairment as potential target areas for treatment.

Here is a list of seven BCI developers you need to know.