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

NCT07127172 · Neuralink Corp · Updated 17 Aug 2025

What is being tested
N1 Implant; R1 Robot
For
Tetraplegia/Tetraparesis; Quadriplegia; Quadriplegia/Tetraplegia; Cervical Spinal Cord Injury; Amyotrophic Lateral Sclerosis (ALS); Spinal Cord Injury (Quadraplegia); Spinal Cord Injury; Motor Neuron Disease; Brain Stem Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 7 people. The full rules are on the registry page.
Where
United Kingdom (2 sites)
When
Starts or started 31 July 2025, ends Feb 2031. Registered 17 Aug 2025.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT07127172

Sites

  • University College London Hospitals NHS Foundation TrustLondon, Greater London, United Kingdom
  • The Newcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon Tyne, Tyne and Wear, United Kingdom