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

RECRUITINGNA

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

NCT07127172•Neuralink Corp

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•(a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.
•OR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.
•Life expectancy ≥ 12 months.
•Ability to communicate in English
•Presence of a stable caregiver

Exclusion Criteria

•Moderate to high risk for serious perioperative adverse events
•Active implanted devices
•Morbid obesity (Body Mass Index \> 40)
•History of poorly controlled seizures or epilepsy
•History of poorly controlled diabetes
•Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
•Acquired or hereditary immunosuppression
•Use of smoking tobacco or other tobacco products
•Psychiatric or psychological disorder
•Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
+1 more criteria

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

Key Dates

Start Date

July 31, 2025

Primary Completion Date

January 1, 2028

Completion Date

February 1, 2031

Last Updated

August 17, 2025

Enrollment

ESTIMATED participants

Conditions

Tetraplegia/TetraparesisQuadriplegiaQuadriplegia/TetraplegiaCervical Spinal Cord InjuryAmyotrophic Lateral Sclerosis (ALS)Spinal Cord Injury (Quadraplegia)Spinal Cord InjuryMotor Neuron DiseaseBrain Stem Stroke

Interventions

N1 Implant

DEVICE

R1 Robot

DEVICE

Contacts

Neuralink Clinical Team

CONTACT

(877) 398-4465 clinical-team-ct@neuralink.com

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

NCT07357428

Amyotrophic Lateral SclerosisNeuromuscular Disease+4 more

View study

RECRUITINGNA

Investigation on the Bidirectional Cortical Neuroprosthetic System

NCT03161067

TetraplegiaQuadriplegia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

Investigation on the Bidirectional Cortical Neuroprosthetic System

UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

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