Elon Musk’s neurotechnology company Neuralink has announced that it has received approval to start recruiting humans for its brain-implant trial.
“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 announced in an official blogpost on September 19, 2023.
The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) – an investigational medical device trial for the Neuralink’s fully-implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of the company’s implant (N1) and surgical robot (R1) and assess the initial functionality of Neuralink’s BCI for enabling people with paralysis to control external devices with their thoughts.
During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a part of the brain that controls movement intention.
Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention.
The initial goal of the company’s BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.
“The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs,” Neuralink said.
The company further mentioned that those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.
According to a report by the Guardian, the company's announcement comes after months of receiving regulatory approval for a trial. Its prior animal testing is under scrutiny due to reports of trials causing unnecessary suffering.