Elon Musk’s Neuralink has announced the initiation of its first-in-human clinical trial, known as the PRIME Study (Precise Robotically Implanted Brain-Computer Interface), following approval from an independent institutional review board and the first hospital site.
The study aims to assess the safety and initial functionality of Neuralink’s fully implantable, wireless brain-computer interface (BCI) for enabling individuals with paralysis to control external devices through thought.
The trial will utilize Neuralink’s R1 Robot to surgically implant the N1 Implant’s ultra-fine threads into the brain region responsible for movement intention. Once implanted, the N1 device is designed to be cosmetically invisible and will wirelessly transmit brain signals to an app that decodes the user’s intended movements. The initial focus of the BCI is to allow individuals to control a computer cursor or keyboard solely through thought.
The PRIME Study received an investigational device exemption (IDE) from the FDA in May 2023 and aims to serve those with unmet medical needs by restoring autonomy through a generalized brain interface. The study is open to individuals who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS).
Neuralink has also established a Patient Registry for those interested in participating in current and future clinical trials. The FDA approved Neuralink for human clinical trials back in May of this year.