Neuralink, the brain-computer interface company founded by Elon Musk, has announced the commencement of its first human clinical trials. The trials, named the PRIME Study (Precise Robotically Implanted Brain-Computer Interface), will span six years and are aimed at testing the company's technology designed to assist individuals with paralysis in controlling devices.
Specifically, the company is seeking participants with quadriplegia resulting from vertical spinal cord injuries or ALS, who are above 22 years of age and have a consistent caregiver. I reported in May that Neuralink had been approved for its first human trials.
The PRIME Study Explained
The PRIME Study will focus on three primary components: the N1 implant, the R1 robot, and the N1 User App. The N1 implant is Neuralink's brain-computer device, the R1 robot is responsible for the surgical implantation of the device, and the N1 User App connects to the N1 implant, translating brain signals into computer actions. The study aims to test the safety and efficacy of all three components.
We're excited to announce that recruitment is open for our first-in-human clinical trial!
If you have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS), you may qualify. Learn more about our trial by visiting our recent blog post.…
— Neuralink (@neuralink) September 19, 2023
The N1 implant will be surgically placed in the brain region controlling movement intention by the R1 Robot. Once installed, the implant will be invisible and will wirelessly transmit brain signals to an app that decodes movement intentions. The primary goal is to enable participants to control a computer cursor or keyboard solely with their thoughts.
The Road to Human Trials
Neuralink's journey to this point has been marked by both advancements and controversies. The company received FDA approval for its trials in May 2023, following a rejection in early 2022. Concerns have been raised over the company's treatment of animals during testing, with allegations of mistreatment of monkeys.
Elon Musk has refuted some of these claims, stating that testing was conducted on terminally ill monkeys and that no monkey fatalities resulted from Neuralink implants. However, the company has faced scrutiny for its treatment of animals and is currently under investigation for transporting pathogen-laced devices removed from monkeys.
Neuralink is not the only company working on brain-computer interfaces. Several other firms, such as Blackrock Microsystems and Kernel, have already conducted human trials with similar devices and reported positive results. However, Neuralink claims that its device is more advanced and less invasive than its competitors.
What's Next for Participants?
Individuals participating in the PRIME Study will first undergo an 18-month study involving nine visits with researchers. Subsequently, they will dedicate at least two hours weekly to brain-computer interface research sessions and participate in 20 more visits over the subsequent five years. While the exact number of subjects Neuralink is seeking remains undisclosed, the company has stated that it will compensate participants for study-related expenses, such as travel.