Tests a brain implant that lets paralyzed people control devices
Tests a brain implant and robot in adults with paralysis from spinal injury or ALS.
Plain-language title generated from the registry record
Registry title: UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Key facts
- Where
- Abu Dhabi, United Arab EmiratesSee the site
Where in United Arab Emirates
- Cleveland Clinic Abu Dhabi (CCAD)Abu Dhabi, United Arab EmiratesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neuralink Corp
- Trial code
- NCT06992596
- Record updated
- 5 June 2025
- Original description
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.Read full original descriptionShow less
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: (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: History of poorly controlled seizures or epilepsy; History of poorly controlled diabetes; Requires magnetic resonance imaging (MRI) for any ongoing medical conditions; Psychiatric or psychological disorder; Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure; Moderate to high risk for serious perioperative adverse events; Morbid obesity (Body Mass Index > 40); Acquired or hereditary immunosuppression; Smoking tobacco or use of other tobacco products > once per month within the last year; Pre-existing damage to the cortical region of interest (as determined by MRI).