Neuralink’s First-in-Human Clinical Trial is Open for Recruitment
Neuralink 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 PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) – a groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of their implant (N1) and surgical robot (R1) and assess the initial functionality of our BCI for empowering people with paralysis to control external peripherals with their thoughts.
During the trial, the R1 Robot was used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention. Once in place, the N1 Implant was cosmetically invisible and was intended to record and transmit brain signals wirelessly to an app that was intended to decodes movement intention. The initial goal of BCI was to grant people the ability to control a computer cursor or keyboard using their thoughts alone.
The PRIME Study was conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represented an important step in mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.
Those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.
If you’re interested in learning whether you may qualify for current and future Neuralink clinical trials, consider visit neuralink.com
