UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
NCT ID: NCT06992596
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-05-09
2027-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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UAE-PRIME: Precise Robotically Implanted Brain-Computer Interface
Open label
N1 Implant
The N1 Implant is a type of implantable brain-computer interface.
R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Interventions
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N1 Implant
The N1 Implant is a type of implantable brain-computer interface.
R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Cleveland Clinic Abu Dhabi
OTHER
Neuralink Corp
INDUSTRY
Responsible Party
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Principal Investigators
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Florian Roser, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Abu Dhabi
Locations
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Cleveland Clinic Abu Dhabi (CCAD)
Abu Dhabi, , United Arab Emirates
Countries
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Central Contacts
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Related Links
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Neuralink's Patient Registry
Neuralink Website
Other Identifiers
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ADHRTC-2025-65
Identifier Type: OTHER
Identifier Source: secondary_id
N1-FS-001
Identifier Type: -
Identifier Source: org_study_id
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