Elon Musk’s brain-chip startup, Neuralink, announced on Tuesday that it has received approval from an independent review board to initiate recruitment for the first human trial of its brain implant designed for patients with paralysis.
Individuals with paralysis from cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS) may qualify for this study. However, Neuralink did not specify the number of participants to be enrolled in the trial, which is expected to span approximately six years.
During the study, a robot will surgically implant a brain-computer interface (BCI) device in a brain region responsible for the intention to move. Neuralink’s initial objective is to empower individuals to control a computer cursor or keyboard solely through their thoughts.
The company initially aimed to secure approval to implant its device in ten patients but reportedly entered negotiations with the U.S. Food and Drug Administration (FDA) to reduce the number of patients due to safety concerns raised by the agency, according to current and former employees. The exact number of patients approved by the FDA remains undisclosed.
Elon Musk envisions ambitious applications for Neuralink, suggesting that it could facilitate swift surgical insertions of its chip devices to address conditions such as obesity, autism, depression, and schizophrenia.
In May, Neuralink announced it had obtained FDA clearance for its first-in-human clinical trial, even as it faced federal scrutiny for handling animal testing.
Nevertheless, even if the BCI device proves safe for human use, experts suggest it may take over a decade for Neuralink to secure commercial clearance for its technology.