GB-PRIME Early Study of a Robotically Implanted Brain-Computer Interface Using the Neuralink N1 Implant and R1 Robot for People with Severe Arm and Hand Paralysis

What this Trial Is About

Researchers are evaluating the safety and functionality of the Neuralink N1 Implant and R1 Robot in people who have tetraparesis, tetraplegia, or similar neurological conditions. This early feasibility study focuses on those with spinal cord injury, brain stem stroke, or progressive diseases like Amyotrophic Lateral Sclerosis ALS, which cause severe upper limb motor impairment. The study aims to understand how well this brain-computer interface device and its robotic implantation system work in this population. The N1 Implant is a wireless, rechargeable device mounted on the skull, with electrode threads inserted into the brain using the R1 Robot, a specialized robotic inserter. Participants receive the implant through a surgical procedure, and the study is open label, meaning everyone knows the treatment being given. The study includes a primary phase and a long-term follow-up to monitor outcomes over time. Participants will be closely monitored through various assessments including tracking device- and procedure-related adverse events up to 48 months after implantation. Cognitive function and mental health will be evaluated using tools such as the Montreal Cognitive Assessment MoCA, Patient Health Questionnaire-9 PHQ-9, and Generalized Anxiety Disorder-7 GAD-7 at multiple timepoints. The study is designed to last several years, providing detailed safety and functional data for this brain-computer interface system.

GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices