NCT06992596 UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
| NCT ID | NCT06992596 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuralink Corp |
| Condition | Tetraplegia/Tetraparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-05-09 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-05-09 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Florian Roser, MD
PRINCIPAL INVESTIGATOR
Cleveland Clinic Abu Dhabi
Frequently Asked Questions
Who can join the NCT06992596 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tetraplegia/Tetraparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06992596 currently recruiting?
Yes, NCT06992596 is actively recruiting participants. Contact the research team at clinical-team-ct@neuralink.com for enrollment information.
Where is the NCT06992596 trial being conducted?
This trial is being conducted at Abu Dhabi, United Arab Emirates.
Who is sponsoring the NCT06992596 clinical trial?
NCT06992596 is sponsored by Neuralink Corp. The principal investigator is Florian Roser, MD at Cleveland Clinic Abu Dhabi. The trial plans to enroll 10 participants.