Musk's company has begun recruiting volunteers for a clinical trial of a neural implant
Neuralink has announced the approval of a clinical trial of brain chips and the start of recruitment of study personnel and participants.The company's independent expert review board and the first hospital have approved the start of a clinical trial of Neuralink's robotic neuroimplants. Ilon Musk's company began recruiting volunteers to participate in the study. In May, Neuralink received approval for human trials from the U.S. Food and Drug Administration (FDA).
During the PRIME study, participants will be fitted with a robotic implanted brain-computer interface. In the first clinical trial, researchers will test the safety of the implant and surgical robot, and evaluate the functionality of the device in people with paralysis to control external devices "by the power of thought."
Patients with quadriplegia (paralysis of the arms and legs) due to spinal cord injury or amyotrophic lateral sclerosis will be eligible to participate in the trial. Only patients who have been receiving other therapies for at least one year without improvement will be eligible for implantation at this stage.
Participants must be at least 22 years old at the start of the study and have a guardian. Patients who are prone to seizures and those who have or have had other implants (such as pacemakers) are not eligible for the trial.
During the surgery, the R1 surgical robot developed by Neuralink will place the N1 implant with ultra-thin and flexible threads into the areas of the brain that control movement. "Once inserted, the N1 implant becomes cosmetically invisible and is designed to record and wirelessly transmit brain signals to an application that decodes the intention of the movement," according to Neuralink.
The study will last six years with constant monitoring of the volunteers. The first phase, the primary study, will include nine home and clinic consultations over 18 months. After that, patients will have to undergo 20 consultations over five years.