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Neuralink Brain Implant Now at Human Trials

• By John K. Waters
• 01/31/2024

Neuralink, the neurotechnology company owned by billioniare enfant terrible Elon Musk, has reached a milestone.

The company this week successfully implanted a coin-sized wireless device into a human, marking Neuralink's first clinical trial of a brain-computer interface (BCI).

"The first human received an implant from @Neuralink yesterday and is recovering well," Musk announced on X this week. "Initial results show promising neuron spike detection."

The "Neuralink chip," which was designed to enable communication between the human brain and computers or machines, was actually implanted in the subject's skull. From the cosmetically invisible implant, wires roughly 20 times thinner than a human hair spread out into the brain. During a 2020 Neuralink progress update presentation, Musk described it as "a Fitbit in your skull with tiny wires."

Neuralink has said the wires would be surgically placed in a region of the brain that controls movement intention. According to the National Institute of Health, the "spikes" Musk mentioned in his post refers to activity by neurons, which are cells that use electrical and chemical signals to send information throughout the brain and to the body. "Neuron spikes detection" means the probes are picking up electrical impulses from the brain.

The initial goal of the so-called brain computer interface is to give people the ability to control a computer cursor or keyboard using their thoughts alone. The company's long-range goal is to create devices that can help treat such neurological conditions as epilepsy, Parkinson's disease, and spinal cord injuries.

The implant was a very big step in Neuralink's PRIME study (Precise Robotically Implanted Brain-Computer Interface), which the company calls "a groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface...[which] aims to evaluate the safety of our implant and surgical robot, and assess the initial functionality of our BCI for enabling people with quadriplegia to control external devices with their thoughts."

Neuralink is not the first to announce a BCI implant. Synchron, a New York City-based implantable neural interface technology company, announced in September 2023 that six people participating in its COMMAND trial received the Synchron Switch. The device was implanted via the blood vessel on the surface of the motor cortex of the brain through the jugular vein. Like the Neuralink device, the Switch was designed to detect and wirelessly transmit motor "intent" from the brain. The goal is to restore the capability of severely paralyzed patients to control personal devices with hands-free point-and-click.

Neuralink received U.S. Food and Drug Administration (FDA) clearance for its first in-human clinical trial in May 2023. The FDA approved an "investigational device exemption" that allowed the trial. This exemption "allows a sponsor to begin a clinical study in patients who fit the inclusion criteria," according to the FDA.

The FDA acknowledged in a statement that the agency cleared Neuralink to use its brain implant and surgical robot for trials on patients.

Neuralink has been criticized for conducting its initial trials of its chip on live monkeys, which led to the deaths of roughly 1,500 of the animals between 2018 and 2022, Reuters reported. 

Neuralink announced in September 2023 in a post on X that it is seeking patients with paralysis to test the brain-computer interface.