The UAE-PRIME Study is a feasibility study designed to assess the initial 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 (>12 months), stroke (>12 months), or other neurological condition causing the participant to experience bilateral upper limb motor impairment, with no expectation of recovery.
Life expectancy ≥ 12 months.
Ability to communicate verbally or with the use of a computer or communication aid, and working proficiency in English.
Presence of a stable caregiver
Moderate to high risk for serious perioperative adverse events
Morbid obesity (Body Mass Index > 40)
History of poorly controlled seizures or epilepsy
History of poorly controlled diabetes
Neuralink Corp
Lead sponsor
Cleveland Clinic Abu Dhabi
Collaborator