UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

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.

Inclusion Criteria:

• (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.

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 participant's treating neurologist, that the disease will progress such that the participant will meet criteria 1a within 1 year of recruitment.

• 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

Exclusion Criteria:

• 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
• Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
• Acquired or hereditary immunosuppression
• Smoking tobacco or use of other tobacco products > once per month within the last year.
• Psychiatric or psychological disorder
• Pre-existing damage to the cortical region of interest (as determined by MRI)
• Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure