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UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices | Clinical Trials | Clareo Health

RECRUITINGNA

UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

NCT06992596•Neuralink Corp

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Cleveland Clinic Abu Dhabi (CCAD)

Abu Dhabi, United Arab Emirates

Key Dates

Start Date

May 9, 2025

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2027

Last Updated

June 5, 2025

Enrollment

ESTIMATED participants

Conditions

Tetraplegia/TetraparesisQuadriplegiaQuadriplegia/TetraplegiaCervical Spinal Cord InjuryAmyotrophic Lateral Sclerosis (ALS)Spinal Cord Injury (Quadraplegia)Spinal Cord InjuryMotor Neuron DiseaseBrain Stem Stroke

Interventions

N1 Implant

DEVICE

R1 Robot

DEVICE

Contacts

Neuralink Clinical Team

CONTACT

(877) 398-4465 clinical-team-ct@neuralink.com

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

NCT07357428

Amyotrophic Lateral SclerosisNeuromuscular Disease+4 more

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RECRUITINGNA

Investigation on the Bidirectional Cortical Neuroprosthetic System

NCT03161067

TetraplegiaQuadriplegia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Inclusion Criteria

Exclusion Criteria

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

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