RecruitingNot ApplicableNCT07127172

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

Sponsor

Neuralink Corp

Enrollment

7 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

Quadriplegia Spinal Cord Injury Motor Neuron Disease Amyotrophic Lateral Sclerosis(ALS)Cervical Spinal Cord Injury Tetraplegia/Tetraparesis Quadriplegia/Tetraplegia Spinal Cord Injury (Quadraplegia)Brain Stem Stroke

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called N1 Implant and a medical device called R1 Robot for people with amyotrophic lateral sclerosis(als), brain stem stroke, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEN1 Implant

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

DEVICER1 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

View Full Details on ClinicalTrials.gov

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NCT07127172

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