GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- The Rate of Device-Related Adverse Events (AE) — 12 months post-implant
- The Rate of Procedure-Related Adverse Events (AE) — 12 months post-implant
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| University College London Hospitals NHS Foundation Trust | London | Greater London | Recruiting |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | Tyne and Wear | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07127172 on ClinicalTrials.gov ↗ ← All trials in the UK