In a significant milestone, Neuralink, a leading player in neurotechnology, has received approval from an independent institutional review board and its first hospital site to commence recruitment for its groundbreaking first-in-human clinical trial. This pivotal trial, known as the PRIME Study (Precise Robotically Implanted Brain-Computer Interface), marks a revolutionary endeavor in the realm of medical devices, focusing on the evaluation of safety, functionality, and promise for individuals with paralysis.
FDA Approval and Fundraising Success
In May 2023, Neuralink announced that it received approval from the US Food and Drug Administration (FDA) to commence human clinical trials. This announcement was followed by a successful fundraising round in August, led by Peter Thiel’s Founders Fund, which raised $280 million.
The Core of the PRIME Study
The PRIME Study centers around Neuralink’s fully implantable, wireless brain-computer interface (BCI) designed to empower individuals with paralysis to control external devices using their thoughts. The study sets out to determine the safety of the N1 Implant and R1 Surgical Robot, along with assessing the initial functionality of the BCI.
The N1 Implant, a marvel of miniaturization, consists of ultra-fine and flexible threads that will be delicately placed in a specific brain region responsible for movement intention. Once in situ, this cosmetically imperceptible implant will record and wirelessly transmit brain signals to an accompanying app, which will decode users’ intentions. Initially, the BCI’s objective is to grant individuals the power to manipulate a computer cursor or keyboard solely through their thoughts.
A Pivotal Stride Towards Neuralink’s Mission
This groundbreaking trial is conducted under the auspices of an investigational device exemption (IDE) granted by the FDA in May 2023. It signifies a pivotal stride toward Neuralink’s overarching mission: to develop a universal brain interface aimed at restoring autonomy for those with unmet medical needs.
Notably, the PRIME Study is actively seeking participants who suffer from quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS). People who might be interested in learning whether they qualify for current and future Neuralink clinical trials are encouraged to join its Patient Registry.
To learn more about this revolutionary study and how it could potentially change the lives of individuals with paralysis, download the study brochure here.