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.
(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.
Life expectancy ≥ 12 months.
Ability to communicate in English
Presence of a stable caregiver
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
Single group
N1 Implant
DeviceThe N1 Implant is a type of implantable brain-computer interface.
R1 Robot
DeviceThe R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
The Rate of Device-Related Adverse Events (AE)
The Rate of Procedure-Related Adverse Events (AE)
The Rate of Device-Related Adverse Events (AE)
The Rate of Procedure-Related Adverse Events (AE)
Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit.
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit.
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Neuralink Corp
Lead sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
University College London Hospitals
Collaborator
