Clinical trial NCT06992596: UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Official title: UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tetraplegia/Tetraparesis
Quadriplegia
Quadriplegia/Tetraplegia
Cervical Spinal Cord Injury
Amyotrophic Lateral Sclerosis (ALS)
Spinal Cord Injury (Quadraplegia)
Spinal Cord Injury
Motor Neuron Disease
Brain Stem Stroke
Keywords: brain computer interface
Neuralink N1 Implant
Neuralink
Robot
tetraparesis
tetraplegia
quadriplegia
ALS
spinal cord injury
Amyotrophic lateral sclerosis
chip
brain chip
External device control
Wireless implant
Neuroprosthetics
SCI
paralysis
motor neuron disease
Lead sponsor: Neuralink Corp
Sponsor class: INDUSTRY
Collaborators: name: Cleveland Clinic Abu Dhabi
First posted: 2025-05-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a prospective, longitudinal, open-label, single-arm feasibility study.
Primary purpose: OTHER

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

Primary outcomes:
measure: The Rate of Device-Related Adverse Events (AE)
timeFrame: 12 months post-implant
measure: The Rate of Procedure-Related Adverse Events (AE)
timeFrame: 12 months post-implant
Secondary outcomes:
measure: The Rate of Device-Related Adverse Events (AE)
timeFrame: Up to 36 months post-implant
measure: The Rate of Procedure-Related Adverse Events (AE)
timeFrame: Up to 36 months post-implant
measure: Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
timeFrame: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation
measure: Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
timeFrame: From baseline to 36-months post-implantation
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
timeFrame: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
timeFrame: From baseline to 36-months post-implantation
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
timeFrame: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
timeFrame: From baseline to 36-months post-implantation
measure: Change in neurological function as assessed by standardized physician neurological exam during the Primary Study
timeFrame: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation
measure: Change in neurological function as assessed by standardized physician neurological exam during the Long-term Follow-up Phase
timeFrame: From baseline to 36-months post-implantation
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi (CCAD)
Study officials:
affiliation: Cleveland Clinic Abu Dhabi
name: Florian Roser, MD
role: PRINCIPAL_INVESTIGATOR
References: