Neuralink, an American neurotechnology developer, is now enrolling participants for a human clinical trial of its Precise Robotically Implanted Brain Computer Interface (PRIME).
In a September news announcement, the company said its R1 surgical robot would place Neuralink’s N1 implant into trial participants with the goal of “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 region of the brain that controls movement intention,” the announcement added. “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 our BCI [brain-computer interface] is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.”
Neuralink said the PRIME study is being conducted thanks to an investigational device exemption provided by the U.S. Food & Drug Administration in May. People diagnosed with amyotrophic lateral sclerosis (ALS) or spinal cord injuries resulting in quadriplegia can join Neuralink’s patient registry to see if they qualify for the trial.
Trial participants must be at least one year post-injury (in the case of spinal cord injury) without improvement in function; must be 22 years old or older; and must have a consistent, reliable caregiver.
People with an active implanted device (such as a pacemaker), with a seizure history, or who require MRIs for medical conditions don’t qualify.