Neuralink has received approval from the independent institutional review board and its first hospital to begin recruiting for its first human clinical trial. The original purpose of the brain-computer interface is to enable people to control a computer cursor or keyboard using only their thoughts.
Neuralink begins recruitment for first human trials
Neuralink said it has received approval from an independent institutional review board and its first hospital to begin recruiting for its first human clinical trial. The study is called PRIME (short for Precise Robotically Implanted Brain-Computer Interface). This is a breakthrough medical device study for the company’s fully implantable wireless brain-computer interface (BCI). It is aimed at assessing the safety of the Neuralink implant (N1) and surgical robot (R1). In addition, the initial functionality of BCI for enabling people with paralysis to control external devices with their thoughts will be assessed.
During the study, the R1 robot will be used to surgically place the ultra-thin and flexible threads of the N1 implant in the brain area. Once installed, the N1 implant becomes cosmetically invisible. It is designed to record and wirelessly transmit brain signals to an application that decodes movement intentions. The original goal of BCI is to enable people to control a computer cursor or keyboard using only their thoughts.
Neuralink received all research permits
The PRIME study is conducted under an Investigational Device Exemption (IDE). It was issued by the FDA in May 2023. This is an important step in Neuralink’s mission to create a universal brain interface to restore autonomy to people with unmet medical needs.
Who can apply?
Those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify for the program. If you would like to see if you may qualify for Neuralink’s current and future clinical trials, consider joining their patient registry here.