UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: N1 Implant, R1 Robot.
- Who it may be relevant to
- Registry conditions: Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device N1 Implant
The N1 Implant is a type of implantable brain-computer interface. - Device R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Primary outcome measures
- The Rate of Device-Related Adverse Events (AE) [Time frame: 12 months post-implant]
- The Rate of Procedure-Related Adverse Events (AE) [Time frame: 12 months post-implant]
Secondary outcome measures (10)
- The Rate of Device-Related Adverse Events (AE) [Time frame: Up to 36 months post-implant]
- The Rate of Procedure-Related Adverse Events (AE) [Time frame: Up to 36 months post-implant]
- Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study [Time frame: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation]
- Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase [Time frame: From baseline to 36-months post-implantation]
- Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study [Time frame: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation]
- Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase [Time frame: From baseline to 36-months post-implantation]
- Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study [Time frame: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation]
- Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase [Time frame: From baseline to 36-months post-implantation]
- Change in neurological function as assessed by standardized physician neurological exam during the Primary Study [Time frame: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation]
- Change in neurological function as assessed by standardized physician neurological exam during the Long-term Follow-up Phase [Time frame: From baseline to 36-months post-implantation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Arab Emirates · 1 center
- Cleveland Clinic Abu Dhabi (CCAD) — Abu Dhabi
Identifiers
NCT: NCT06992596 · N1-FS-001 · ADHRTC-2025-65