Neuralink, Elon Musk's startup focused on developing implantable, wireless brain-computer interfaces, has recently commenced recruitment for its first human trial. The trial, known as the PRIME study, has received approval from an independent institutional review board and the trial's first hospital site.
The objective of the PRIME study is to assess both the safety and functionality of the Neuralink implant and its surgical robot. The brain-computer interface being developed by Neuralink has the potential to restore vision and provide individuals with severe disabilities the ability to move and communicate by decoding brain activity.
According to a study brochure published by Neuralink, brain-computer interfaces are systems that interpret brain activity to control external devices like computers. The study aims to evaluate the interface's effectiveness in enabling individuals with paralysis to control devices.
Neuralink's implant technology has undergone extensive testing on primates over the years. In a video released by the company in April 2021, a monkey implanted with two Neuralink devices successfully played a videogame called Pong using only its brain.
The recruitment for the human trial is focused on individuals with quadriplegia caused by spinal cord injury or amyotrophic lateral sclerosis (ALS). Participants must have at least one year since their injury without any signs of improvement. Additionally, candidates must be at least 22 years old and have a reliable caregiver.
The primary study is expected to last approximately 18 months, with long-term follow-up sessions extending the total trial duration to around six years.
Neuralink received approval from the Food and Drug Administration for its first in-human clinical study in May. The company's groundbreaking work in the field of brain-computer interfaces has the potential to revolutionize how individuals with disabilities interact with and control technology.