Shillong, September 20: Elon Musk’s brain-computer interface company, Neuralink, has initiated the recruitment of its first test subjects for human trials aimed at assisting individuals with paralysis in controlling devices.
As per IANS, 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 PRIME Study’s primary objective is to evaluate the safety of the N1 Implant and R1 Robot, along with assessing the initial functionality of the wireless brain-computer interface. This technology is designed to empower people with paralysis to control external devices using their thoughts.
During the study, the R1 Robot will surgically place ultra-fine and flexible threads from the N1 Implant into the brain region responsible for controlling movement intention. Once implanted, the N1 Implant is discreetly concealed and intends to record and wirelessly transmit brain signals to an app capable of decoding movement intention.
Neuralink’s initial goal is to enable individuals to control a computer cursor or keyboard solely through their thoughts.
The PRIME Study operates under the investigational device exemption (IDE) granted by the FDA in May 2023. Neuralink expressed its dedication to creating a generalized brain interface to restore autonomy to individuals with unmet medical needs.
The trial is open to those with quadriplegia resulting from cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) and is expected to span six years.
Notably, in March of the same year, the FDA had rejected Neuralink’s proposal to implant a brain chip in humans due to safety concerns.
It’s worth mentioning that Neuralink is not the first to venture into brain-computer interface trials. Rival company Synchron began human trials in the United States last year, enabling six severely paralyzed patients to control digital devices hands-free using their thoughts.
