Neuralink Gains Approval for Human Trials of Brain Implant to Aid Paralysis Patients

Neuralink, the brain-chip startup company founded by billionaire entrepreneur Elon Musk, has announced a significant milestone: receiving approval from an independent review board to initiate recruitment for the first human trial involving their brain implant designed for patients with paralysis.

The trial aims to enroll individuals experiencing paralysis due to cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS), though the exact number of participants for the study remains undisclosed. The trial is projected to span approximately six years to complete.

Neuralink plans to employ a robot for the surgical implantation of a brain-computer interface (BCI) in a specific brain region responsible for movement intent. The primary objective is to empower participants to manipulate a computer cursor or keyboard using their thoughts alone.

However, experts suggest that even if the BCI device demonstrates safety for human use, it could still take over a decade for the startup to obtain commercial clearance for widespread use.

Initially, Neuralink had aimed to secure approval for implanting its device in 10 patients, but discussions with the U.S. Food and Drug Administration (FDA) have led to a potential reduction in the number of participants due to safety concerns raised by the agency.

Elon Musk's visionary goals for Neuralink encompass swift surgical deployments of chip devices to address a range of medical conditions, such as obesity, autism, blindness, depression, schizophrenia, and beyond. In May, Neuralink had already received clearance from the FDA for its first-in-human clinical trial, despite being under scrutiny for their handling of animal testing.