MedTrace Logo

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

NCT07127172 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-08-17

No results posted yet for this 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.

Conditions

  • 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

Interventions

DEVICE

N1 Implant

The N1 Implant is a type of implantable brain-computer interface.

DEVICE

R1 Robot

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER

  • University College London Hospitals

    collaborator OTHER

  • Neuralink Corp

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2028-01-31
Completion
2031-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07127172 on ClinicalTrials.gov