Robotically implanted brain chip to help control external devices
UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
This tests a wireless, rechargeable brain implant (Neuralink N1) and a robot surgical system (R1) to help people with severe arm and hand paralysis control external devices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neuralink Corp Industry-sponsored |
| Locations | 1 site (Abu Dhabi) |
| Trial ID | NCT06992596 on ClinicalTrials.gov |
What this trial studies
This is a feasibility study of the Neuralink N1 implant and the R1 robotic insertion system, designed to measure initial clinical safety and basic functionality in humans. The N1 is a skull‑mounted, wireless, rechargeable device connected to fine electrode threads that the R1 Robot places into the brain. Participants will be adults with long-standing bilateral upper limb motor impairment from conditions such as cervical spinal cord injury or ALS, and will undergo implantation and follow-up assessments at the study site. The primary focus is early safety and whether the system can reliably record signals that allow control of external devices.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic tetraparesis or quadriplegia (for example from cervical spinal cord injury or progressive conditions like ALS), who have a stable caregiver, can communicate, and meet surgical safety criteria.
Not a fit: People with uncontrolled seizures, morbid obesity (BMI > 40), high perioperative risk, or life expectancy under 12 months are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the implant could allow people with severe paralysis to control computers, phones, or assistive devices more directly and independently.
How similar studies have performed: Prior intracortical brain–computer interface work (for example BrainGate and other implant systems) has shown proof-of-concept control of cursors and robotic devices, but the Neuralink N1 and R1 robot approach is novel and early in human testing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Abu Dhabi
- Cleveland Clinic Abu Dhabi (CCAD) — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Florian Roser, MD — Cleveland Clinic Abu Dhabi
- Study coordinator: Neuralink Clinical Team
- Email: clinical-team-ct@neuralink.com
- Phone: (877) 398-4465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.