The clinical trial, which is expected to last approximately six years, focuses on establishing a brain-computer interface using the state-of-the-art R1 surgical robot. This complex procedure targets the area of ​​the human brain responsible for motor functions, allowing participants to control a computer cursor or keyboard using the power of thought.

Human testing allowed

On Tuesday, September 19, Neuralink announced that it had received approval from an independent ethics committee to begin the process of recruiting patients to participate in the first clinical trial using the N1 implant.

The study, called PRIME (Precision Robotic Implanted Brain-Computer Interface), aims to evaluate the safety of the N1 implant and the R1 surgical robot, as well as evaluate the functionality of the neurointerface.

Neurochip N1 – a neurointerface prototype / Photo: Nueralink

A key moment for Neuralink came earlier this year when the company received approval from the US Food and Drug Administration (FDA) to begin clinical trials in humans. It’s important to note that the company has previously come under scrutiny from regulatory authorities for its animal testing.

Who can participate in the exams?

People who have had a stroke due to cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS) may be potential participants in clinical trials. However, Neuralink does not publicly disclose the exact number of participants in the study.

How will the implant placement process take place?

The PRIME study will use the R1 surgical robot to place BCI implants in the region of the brain responsible for formulating movement intentions. Virtually undetectable once inserted, the N1 implant is designed to wirelessly transmit brain signals to a companion app that displays movement intentions.

Robot performing chip placement / Photo: Neuralink

The main purpose of Neuralink is to provide control of a computer cursor or keyboard solely with the power of human thought.

Elon Musk sees many potential applications for Neuralink technology, including speeding up surgeries using the chip to treat diseases such as obesity, autism, depression and schizophrenia.

But experts warn that even if the neuroimplant is deemed safe for humans, the path to commercial approval could take more than a decade. These long timelines are due to the stringent safety standards set by the FDA, which emphasize the thorough and comprehensive evaluation process required to ensure the safety and effectiveness of the technology.