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

NCT06992596 | Recruiting DMC

• 2 other identifiers: N1-FS-001ADHRTC-2025-65
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• The Rate of Device-Related Adverse Events (AE)

  12 months post-implant

• The Rate of Procedure-Related Adverse Events (AE)

  12 months post-implant

Secondary Outcomes (10)

• The Rate of Device-Related Adverse Events (AE)

  Up to 36 months post-implant

• The Rate of Procedure-Related Adverse Events (AE)

  Up to 36 months post-implant

• Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study

  From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation

• Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase

  From baseline to 36-months post-implantation

• Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study

  From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation

Study Arms (1)

UAE-PRIME: Precise Robotically Implanted Brain-Computer Interface

OTHER

Open label

Device: N1 Implant; Device: R1 Robot

Interventions

N1 Implant DEVICE

The N1 Implant is a type of implantable brain-computer interface.

UAE-PRIME: Precise Robotically Implanted Brain-Computer Interface

R1 Robot DEVICE

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

UAE-PRIME: Precise Robotically Implanted Brain-Computer Interface

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuralink Corp: lead
• Cleveland Clinic Abu Dhabi: collaborator

Study Sites (1)

Cleveland Clinic Abu Dhabi (CCAD)

Abu Dhabi, 112412, United Arab Emirates

RECRUITING

Related Links

• Neuralink's Patient Registry
• Neuralink Website

MeSH Terms

Conditions

Quadriplegia; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Motor Neuron Disease; Brain Stem Infarctions; Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Florian Roser, MD

  Cleveland Clinic Abu Dhabi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neuralink Clinical Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, longitudinal, open-label, single-arm feasibility study.

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 28, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)