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NCT Number: NCT06992596

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

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.

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Key information

Conditions

Tetraplegia/Tetraparesis Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS) Brain Diseases Brain Infarction Brain Ischemia Brain Stem Infarctions Brain Stem Stroke Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cervical Spinal Cord Injury Infarction Ischemia Metabolic Diseases Motor Neuron Disease Necrosis Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Quadriplegia/Tetraplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Spinal Cord Injury (Quadraplegia) Stroke TDP-43 Proteinopathies Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Abu Dhabi (CCAD)

Abu Dhabi, 112412, United Arab Emirates

Location status: Recruiting

Location contact

Florian Roser, MD, PhD

PRINCIPAL_INVESTIGATOR

Mohamed Samy Elhammady, MD

PRINCIPAL_INVESTIGATOR

Tanmoy Maiti, MBBS, MCH, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N1 Implant

Device

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

R1 Robot

Device

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

Primary outcomes

  1. The Rate of Device-Related Adverse Events (AE)

    Time frame: 12 months post-implant

  2. The Rate of Procedure-Related Adverse Events (AE)

    Time frame: 12 months post-implant

Secondary outcomes

  1. The Rate of Device-Related Adverse Events (AE)

    Time frame: Up to 36 months post-implant

  2. The Rate of Procedure-Related Adverse Events (AE)

    Time frame: Up to 36 months post-implant

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

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

    The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit.

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

    Time frame: From baseline to 36-months post-implantation

    The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit.

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

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

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale used to assess depression severity. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Outcome will be reported as change from baseline at each follow-up visit.

  6. Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase

    Time frame: From baseline to 36-months post-implantation

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale used to assess depression severity. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Outcome will be reported as change from baseline at each follow-up visit.

  7. Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study

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

    The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety severity. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Outcome will be reported as change from baseline at each follow-up visit.

  8. Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase

    Time frame: From baseline to 36-months post-implantation

    The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety severity. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Outcome will be reported as change from baseline at each follow-up visit.

  9. Change in neurological function as assessed by standardized physician neurological exam during the Primary Study

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

    Neurological function will be assessed by a study physician using a standardized neurological exam covering motor strength, reflexes, coordination, cranial nerve function, and sensory status.

  10. Change in neurological function as assessed by standardized physician neurological exam during the Long-term Follow-up Phase

    Time frame: From baseline to 36-months post-implantation

    Neurological function will be assessed by a study physician using a standardized neurological exam covering motor strength, reflexes, coordination, cranial nerve function, and sensory status.

Study contacts

Contact information is provided by the study sponsor or research team.

Neuralink Clinical Team

CONTACT

[email protected]

(877) 398-4465

Sponsors and collaborators

Lead sponsor

Neuralink Corp

Industry

Collaborators

  • Cleveland Clinic Abu Dhabi

Registry information

Acronym: UAE-PRIME

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 28, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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