In a leap towards blending humanity and technology, Neuralink has received the green light to initiate recruitment for its inaugural human clinical trial, dubbed the PRIME Study (Precise Robotically Implanted Brain-Computer Interface).
The Tuesday announcement marks the commencement of a groundbreaking endeavor to integrate a fully implantable, wireless brain-computer interface (BCI) to assist individuals with paralysis.
The PRIME Study aims to “evaluate the safety of our implant (N1) and surgical robot (R1)” and assess the primary functionality of the brain-computer interface, allowing paralyzed individuals to control external devices via thought.
The project has been conceived with the intent to “create a generalized brain interface to restore autonomy to those with unmet medical needs.”
The study is a significant stride in realizing the stated goal of enabling individuals to operate computer cursors or keyboards “using their thoughts alone.”
The focus will be on those suffering from quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS).
Neuralink’s robotic innovation, the R1 Robot, is slated to place the N1 Implant’s ultra-fine, flexible threads meticulously in a brain region governing movement intention.
Once operational, the N1 Implant is expected to be “cosmetically invisible,” aiming to wirelessly record and transmit brain signals to an app deciphering movement intentions.
The explorative journey of Neuralink, led by visionary entrepreneur Elon Musk, is conducted under the investigational device exemption (IDE), a prestigious acknowledgment awarded by the FDA in May 2023.
The FDA’s approval underscores the potential of the PRIME Study to pioneer medical enhancements by leveraging advanced technology.
This revolutionary study heralds a new era in medical science, intending to bridge cognitive functionalities with external devices, promising a renewed sense of autonomy and control to those grappling with paralysis.
The company enunciated, “We are happy to announce that we’ve received approval from the reviewing independent institutional review board and our first hospital site to begin recruitment for our first-in-human clinical trial.”
Neuralink’s advancements underline the convergence of medical science and technology, aiming to develop solutions for individuals with severe medical conditions.
The recruitment is now open for eligible candidates, marking a significant milestone in the relentless pursuit of melding human cognition with technological prowess, potentially unraveling new realms of possibilities in medical science and human interaction with the digital world.
The inception of the PRIME Study brings forth the controversial potential of intertwining thoughts with actions, paving the way for a future of unexplored opportunities and potential dangers.
Previously, the FDA had rejected Neurlink’s request for a human trial, citing “growing employee concern that the company is rushing experiments, causing additional suffering and deaths of pigs, sheep, and monkeys.”
The FDA detailed safety issues with the company, including the use of lithium batteries, migration of the wires, and potential damage to brain tissue.
Few other details are known about the 2022 request and subsequent rejection.
The matter also involved congressmen Earl Francis Blumenauer (D-OR) and Adam Schiff (D-CA) signing a draft letter to the U.S. Department of Agriculture (USDA) inquiring about how Neurolink conducted its experiments.
“At the time of this letter, serious allegations have been leveled against Elon Musk’s company Neuralink,” the letter states.
“These complaints include graphic descriptions of botched experiments and unnecessary animal suffering and death, reportedly as a result of pressure from Mr. Musk to irresponsibly accelerate development of the company’s products at the expense of animal safety.”
