GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
NCT ID: NCT07127172
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
7 participants
INTERVENTIONAL
2025-07-31
2031-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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GB-PRIME: Precise Robotically Implanted Brain-Computer Interface
Open label
N1 Implant
The N1 Implant is a type of implantable brain-computer interface.
R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Interventions
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N1 Implant
The N1 Implant is a type of implantable brain-computer interface.
R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
University College London Hospitals
OTHER
Neuralink Corp
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Related Links
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Neuralink UK Patient Registry
Neuralink Website
Other Identifiers
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354112
Identifier Type: OTHER
Identifier Source: secondary_id
N1-EFS-006
Identifier Type: -
Identifier Source: org_study_id
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