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GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Sponsor: Neuralink Corp
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
7
Start Date
2025-07-31
Completion Date
2031-02
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
N1 Implant
The N1 Implant is a type of implantable brain-computer interface.
R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Locations (2)
University College London Hospitals NHS Foundation Trust
London, Greater London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom