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

The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions. The N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.

NCT Number	NCT07127172
Lead Sponsor	Neuralink Corp Collaborators: Newcastle-upon-Tyne Hospitals NHS Trust, University College London Hospitals
Conditions	Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Injury (Quadraplegia), Spinal Cord Injury, Motor Neuron Disease +1 more
Enrollment	7 participants
Start Date	2025-07-31
Primary Completion	2028-01 (estimated)
Study Completion	2031-02 (estimated)
Updated on ClinicalTrials.gov	2025-08-17