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

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.

NCT Number	NCT06700304
Lead Sponsor	Neuralink Corp Collaborators: University Health Network, Toronto
Conditions	Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Injury (Quadraplegia), Spinal Cord Injury
Enrollment	6 participants
Start Date	2024-11-20
Primary Completion	2027-11-30 (estimated)
Study Completion	2030-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-31