Health TrialsbyHealthPanel

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

ConditionsTetraplegia/TetraparesisQuadriplegiaQuadriplegia/TetraplegiaCervical Spinal Cord InjuryAmyotrophic Lateral Sclerosis (ALS)Spinal Cord Injury (Quadraplegia)Spinal Cord InjuryMotor Neuron DiseaseBrain Stem Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuralink Corp

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

(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.

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: UAE-PRIME: Precise Robotically Implanted Brain-Computer InterfaceOther 2 interventions

Trial outcomes

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

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.

Time frame
From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation
4

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

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.

Time frame
From baseline to 36-months post-implantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neuralink Corp

Lead sponsor

Cleveland Clinic Abu Dhabi

Collaborator

Source ClinicalTrials.gov
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