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

Launched by NEURALINK CORP · May 19, 2025

Keywords

ClinConnect Summary

The UAE-PRIME study is looking at a new device called the Neuralink N1 Implant, which is designed to help people with severe mobility challenges, like those caused by spinal cord injuries or conditions like ALS (Amyotrophic Lateral Sclerosis). This implant is placed in the brain using a special robot called the R1, which safely inserts tiny wires into the brain to help control external devices. The main goal of this study is to see if the implant is safe and how well it works for people who have lost the ability to use their arms and hands.

To participate in this study, individuals must have a diagnosis of a spinal cord injury or another neurological condition that has caused significant weakness in both arms for over a year, and their doctor must believe their condition will not improve. Participants should also be able to communicate in English, have a stable caregiver, and expect to live for at least another year. However, some people may not be eligible due to certain health issues or risks. If someone qualifies and joins the study, they can expect to learn more about this innovative technology and how it might help improve their quality of life.

Gender

ALL

Eligibility criteria

• 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