On Tuesday, Neuralink, the brain-computer interface startup led by Elon Musk, announced that it has secured the necessary approval to initiate its inaugural human trial to assist individuals affected by paralysis.
This development marks a significant milestone in the venture’s journey toward integrating technology and the human brain. Potential candidates for this groundbreaking study are individuals who have suffered cervical spinal cord injuries or are battling amyotrophic lateral sclerosis (ALS). While the exact number of enrollees remains undisclosed, the trial is projected to span approximately six years.
During the trial, a specialized robot will surgically install a brain-computer interface (BCI) implant in a specific area of the participant’s brain, responsible for governing movement intention. The primary objective of this initial phase is to enable participants to manipulate a computer cursor or keyboard solely through thought processes.
Previously, Neuralink had expressed hopes of gaining approval for including 10 participants in this trial. However, conversations with the U.S. Food and Drug Administration (FDA) have possibly led to a revision in the number, following some safety concerns raised by the agency. The precise number of approved participants remains unclear at this point.
Elon Musk plans for Neuralink to extend far beyond this initial trial. He envisions a future where the technology could potentially address various conditions, including obesity, autism, depression, and schizophrenia, through rapid surgical implantations of chip devices.
Earlier in May, Neuralink mentioned that it had obtained FDA clearance to conduct its first human clinical trial despite facing federal scrutiny over its approach to animal testing. Industry experts caution that even if the current trial demonstrates the safety of the BCI device in humans, the journey towards commercial clearance could stretch over a decade, delineating the long road ahead for the startup in revolutionizing medical technology.