Tests a brain implant and robot placement device in people with paralysis
Tests a brain implant in adults with paralysis from spinal injury or ALS.
Plain-language title generated from the registry record
Registry title: GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Key facts
- Where
- London and Newcastle upon Tyne, United KingdomSee the 2 sites
Where in United Kingdom
- University College London Hospitals NHS Foundation TrustLondon, United KingdomTaking people
- The Newcastle Upon Tyne Hospitals NHS Foundation TrustNewcastle upon Tyne, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neuralink Corp
- Trial code
- NCT07127172
- Record updated
- 17 August 2025
- Original description
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.Read full original descriptionShow less
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
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.
Inclusion: (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: History of poorly controlled seizures or epilepsy; History of poorly controlled diabetes; Requires magnetic resonance imaging (MRI) for any ongoing medical conditions; 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; Moderate to high risk for serious perioperative adverse events; Active implanted devices; Morbid obesity (Body Mass Index > 40); Acquired or hereditary immunosuppression; Use of smoking tobacco or other tobacco products.