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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
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 criteria
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.
* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
Study design
Enrollment target: 7 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-31
Estimated completion: 2031-02
Last updated: 2025-08-17
Interventions
Device: N1 ImplantDevice: R1 Robot
Primary outcomes
- • The Rate of Device-Related Adverse Events (AE) (12 months post-implant)
- • The Rate of Procedure-Related Adverse Events (AE) (12 months post-implant)
Sponsor
Neuralink Corp · industry
With: Newcastle-upon-Tyne Hospitals NHS Trust, University College London Hospitals
Contacts & investigators
ContactNeuralink Clinical Team · contact · clinical-team-ct@neuralink.com · (877) 398-4465
All locations (2)
University College London Hospitals NHS Foundation TrustRecruiting
London, Greater London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation TrustRecruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom