The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.
Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
Life expectancy ≥ 12 months.
Ability to communicate in English
Presence of a stable caregiver
Moderate to high risk for serious perioperative adverse events
Active implanted devices
Morbid obesity (Body Mass Index > 40)
History of poorly controlled seizures or epilepsy
Single group
N1 Implant
DeviceThe N1 Implant is a type of implantable brain-computer interface.
R1 Robot
DeviceThe R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
The Rate of Device-Related Adverse Events (AE)
The Rate of Procedure-Related Adverse Events (AE)
The Rate of Device-Related Adverse Events (AE)
The Rate of Procedure-Related Adverse Events (AE)
Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
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Neuralink Corp
Lead sponsor
University Health Network, Toronto
Collaborator
