CAN-PRIME Testing a Precise Robotically Placed Brain Implant to Help Control Devices for People with Severe Arm and Leg Movement Loss

What this Trial Is About

Researchers are evaluating the safety and function of Neuralinks N1 Implant and R1 Robot in people who have difficulty moving their arms and legs due to conditions like tetraplegia or tetraparesis. The study aims to understand how well this brain-computer interface and its robotic implantation system work in individuals who have severe movement impairments, including those with spinal cord injury or amyotrophic lateral sclerosis ALS. The N1 Implant is a small, wireless device placed inside the skull and connected to tiny threads inserted into the brain by the R1 Robot, a machine designed to precisely implant these threads. This is an open-label study where participants receive the implant and robot-assisted procedure to explore the devices performance and safety over time. Participants will be closely monitored through multiple assessments over 12 months post-implant, including tracking device- and procedure-related adverse events. Cognitive and mental health evaluations using tools like the Montreal Cognitive Assessment MoCA, Patient Health Questionnaire-9 PHQ-9, and Generalized Anxiety Disorder-7 GAD-7 will be done at regular intervals up to 36 months. The study involves ongoing follow-up to assess long-term effects and safety.

CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices