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
Neuralink Corp
Lead sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
University College London Hospitals
Collaborator