Neuralink, the brain-chip startup led by billionaire entrepreneur Elon Musk, announced on that it has obtained approval from an independent review board to initiate the recruitment process for its inaugural human trial involving a brain implant designed for individuals with paralysis.
The trial will consider individuals suffering from paralysis due to cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS) as potential participants. However, specific details regarding the number of participants in the study were not disclosed. The trial is expected to span approximately six years to reach completion.
Neuralink’s approach will involve the use of a robotic system to surgically implant a brain-computer interface (BCI) device into a specific brain region responsible for controlling voluntary movements. The primary objective of this trial is to enable individuals to control a computer cursor or keyboard solely through their thoughts.
Initially, Neuralink had aimed to secure approval to implant its device in ten patients, but discussions with the U.S. Food and Drug Administration (FDA) resulted in a lower number due to safety concerns, as suggested by both current and former employees. The exact number of patients approved by the FDA remains undisclosed.
Elon Musk envisions broad applications for Neuralink, aiming to facilitate swift surgical implantations of its chip devices to address conditions such as obesity, autism, depression, and schizophrenia.
In May, the company announced FDA clearance for its first-ever human clinical trial, despite undergoing federal scrutiny for its animal testing practices. Even if the BCI device proves safe for human use, experts suggest that obtaining commercial clearance could still take more than a decade for the startup.
