Elon Musk's brain-computer interface company, Neuralink, has initiated recruiting its first test subjects for human trials aimed at assisting individuals with paralysis in controlling devices.
Neuralink announced that it has obtained approval from an independent institutional review board and the initial hospital site, enabling the commencement of recruitment for its first-in-human clinical trial known as "The PRIME Study" (Precise Robotically Implanted Brain-Computer Interface).
The investigational medical device trial for a fully implantable, wireless brain-computer interface (BCI) - aims to evaluate the safety of the implant (N1) and surgical robot (R1) and assess the initial functionality of the implant for enabling people with paralysis to control external devices with their thoughts.
The company is looking for people with quadriplegia due to vertical spinal cord injury or ALS who are over the age of 22 and have a "consistent and reliable caregiver" to be part of the study.
The exact number of participants slated for enrollment remains undisclosed. The trial is anticipated to span approximately six years.
Previously, the company had aspired to secure approval for implanting its device in ten patients, Reuters noted.
However, following safety concerns raised by the FDA, negotiations reduced the number of patients.
In May, Neuralink disclosed that it had received clearance from the FDA for its inaugural human clinical trial, even amid federal scrutiny of its handling of animal testing.
Nevertheless, experts caution that even if the BCI device proves safe for human use, obtaining commercial use clearance may require more than a decade of further development and evaluation.
Last month, Neuralink announced a new $280 million funding investment led by Founders Fund, a venture capital firm co-founded by Peter Thiel.