Neuralink is currently recruiting the first group of human volunteers to participate in the experimental implantation of their devices into the brain. The company has announced that the Human Research and Hospital Ethics Committee (name undisclosed) has approved the recruitment of volunteers.
The company aims to recruit volunteers with half a spinal cord injury or amyotrophic lateral sclerosis (ALS), who will undergo the surgical implantation of the wireless brain-computer interface device called N1. This device, implanted robotically through the R1 company’s surgical robot, consists of 1,024 electrodes distributed along 64 fibers, thinner than human hair. The electrical terminals will record neural activity related to movement and will decode these signals.
Neuralink states that the goal of implanting the N1 device is to allow participants to control a cursor using their thoughts. The experiment prioritizes safety and will also assess efficacy. According to Ars Technica, this clinical trial does not yet appear in the government’s central clinical trial database (clinicaltrails.gov), and it remains unclear how many volunteers Neuralink will accept.
Previously, Neuralink encountered issues with obtaining permission from the U.S. Food and Drug Administration (FDA). The request was initially denied due to concerns regarding the safety of the lithium battery device, the feasibility of device migration, and the uncertainty surrounding the removal of the device without damaging brain tissue.
However, in May, Neuralink announced that they received the go-ahead from the FDA to proceed with human trials. This study, called the PRIME study, will take over six years to complete, with participants undergoing evaluation up to nine times within 18 months. Subsequent long-term follow-ups, including 20 additional check-ups, will extend over five years.
TLDR: Neuralink, a company founded by Elon Musk, is recruiting its first group of human volunteers to undergo experimental brain implantation procedures. The volunteers, who have spinal cord injuries or ALS, will receive the N1 brain-computer interface device. The goal is to enable participants to control a cursor using their thoughts. The study will prioritize safety, evaluate efficacy, and may take over six years to complete.