NCT06992596Recruiting
UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Source: ClinicalTrials.gov · Last updated 5 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 9 May 2025
- Start date
- 9 May 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Neuralink Corp
- Diseases
- ALS (motor neurone disease), Stroke
- NCT number
- NCT06992596
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 9 May 2025 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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)
Who the study is looking for
- (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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Abu Dhabi (CCAD) Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.