In brief: Elon Musk's brain-implant company Neuralink is now accepting applications for its first human clinical trial. The PRIME Study, which is short for Precise Robotically Implanted Brain-Computer Interface, will evaluate the safety of Neuralink's fully implantable, wireless brain-computer interface (BCI) as well as the surgical robot used to install the device.
The study will additionally assess the functionality of the implant, which is designed to allow patients with paralysis to control external devices using their mind.
The BCI will be placed in the region of the brain that controls movement intention, Neuralink said. Once in place, it will be cosmetically invisible but will link wirelessly to an app that decodes movement intention. Neuralink hopes the device will allow users to control a mouse cursor or keyboard using only their thoughts.
Back in May, the FDA granted Neuralink permission to perform a human trial under an investigational device exemption (IDE).
Neuralink said patients with quadriplegia due to a cervical spinal cord injury or those with amyotrophic lateral sclerosis (ALS) may qualify for the trial. Participants must be at least 22 years old and have a consistent and reliable caregiver. Those with an active implanted device like a pacemaker or deep brain stimulator are unable to participate, as are those with a history of seizures and people that require MRIs for an ongoing medical condition.
Neuralink said it expects the study to run for approximately six years, during which patients will have regular follow-ups with the Neuralink team to monitor progress. Interested parties can join the patient registry to get the ball rolling.
As Reuters highlights, it is unclear how many patients Neuralink is seeking for the trial or how many the FDA will ultimately approve. Former and current Neuralink employees reportedly told the publication that the company was negotiating a number lower than 10, so perhaps only a handful of participants will be involved in the first trial.
No word yet on when the first implants might be installed.
Image credit: Growtika