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Neuralink’s First-in-Human Clinical Trial is Open for Recruitment

Posted on September 21, 2023

Elon Musk’s Neuralink is now recruiting participants for their first-in-human clinical trial of their brain-computer interface (BCI) implant. The PRIME Study aims to assess the safety of the implant and surgical robot, as well as the initial functionality of the BCI for enabling people with paralysis to control external devices with their thoughts.

During the study, the R1 robot will be used to surgically implant the N1 implant in a region of the brain that controls movement intention. Once implanted, the N1 implant will record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of the BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.

The PRIME Study is being conducted under the FDA’s investigational device exemption (IDE) and is the first step in Neuralink’s mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.

People with quadriplegia due to cervical spinal cord injury or ALS may qualify for the study. The study will take approximately 6 years to complete and involves a combination of 9 at-home and in-person clinic visits over approximately 18 months.

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