Tetraplegia/TetraparesisUAE-PRIMENCT06992596
UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
A study testing N1 Implant and R1 Robot in people with Tetraplegia/Tetraparesis and Quadriplegia, run by Neuralink Corp at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia
- What is being tested?
- N1 Implant and R1 Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 9 May 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Cleveland Clinic Abu Dhabi (CCAD)
Abu Dhabi, 112412
Florian Roser, MD, PhD
Tanmoy Maiti, MBBS, MCH, MD
About this study
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)
- Being tested
- N1 Implant, R1 Robot
- 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
- Medical subject headings
- Quadriplegia, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Motor Neuron Disease, Brain Stem Infarctions, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1 ImplantDevice
The N1 Implant is a type of implantable brain-computer interface.
R1 RobotDevice
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
| Study group | Role | What they receive |
|---|---|---|
| UAE-PRIME: Precise Robotically Implanted Brain-Computer Interface | Other | Open label Receives: Device: N1 Implant; Device: R1 Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Device-Related Adverse Events (AE)
Measured: 12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Measured: 12 months post-implant
Secondary outcomes (10)
The Rate of Device-Related Adverse Events (AE)
Measured: Up to 36 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Measured: Up to 36 months post-implant
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.
Measured: 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
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.
Measured: From baseline to 36-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
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.
Measured: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
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.
Measured: From baseline to 36-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
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.
Measured: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
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.
Measured: From baseline to 36-months post-implantation
Change in neurological function as assessed by standardized physician neurological exam during the Primary Study
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.
Measured: From baseline to 30-days, 3-, 6-, 9-, and 12-months post-implantation
Change in neurological function as assessed by standardized physician neurological exam during the Long-term Follow-up Phase
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.
Measured: From baseline to 36-months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start9 May 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetraplegia/TetraparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a prospective, longitudinal, open-label, single-arm feasibility study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuralink Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cleveland Clinic Abu Dhabi
- Responsible party
- Sponsor
- Investigators
- Florian Roser, MD, Principal investigator, Cleveland Clinic Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992596
- Sponsor's protocol ID
- N1-FS-001
- Other IDs
- ADHRTC-2025-65
- Acronym
- UAE-PRIME
- Status last verified
- Jun 2025
- First submitted
- 9 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
- ClinicalTrials.gov ID
- NCT06992596
- Acronym / sponsor ID
- UAE-PRIME / N1-FS-001
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Injury (Quadraplegia)
- Keywords
- brain computer interface, Neuralink N1 Implant, Neuralink, Robot, tetraparesis, tetraplegia, quadriplegia, ALS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Neuralink CorpIndustry (pharma, biotech, devices)
- Collaborators
- Cleveland Clinic Abu Dhabi
- Study start
- 9 May 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, longitudinal, open-label, single-arm feasibility study.
| Arm | Type | Receives |
|---|---|---|
| UAE-PRIME: Precise Robotically Implanted Brain-Computer Interface | Other | Device: N1 Implant, Device: R1 RobotOpen label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N1 ImplantThe N1 Implant is a type of implantable brain-computer interface. | Device | UAE-PRIME: Precise Robotically Implanted Brain-Computer Interface |
| R1 RobotThe R1 Robot is a robotic electrode thread inserter that implants the N1 Implant. | Device | UAE-PRIME: Precise Robotically Implanted Brain-Computer Interface |
Primary outcome
The Rate of Device-Related Adverse Events (AE)
Time frame: 12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: 12 months post-implant
10 secondary outcomes
The Rate of Device-Related Adverse Events (AE)
Time frame: Up to 36 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: Up to 36 months post-implant
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
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
Time frame: From baseline to 36-months post-implantation
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Neuralink's Patient RegistryLink provided by the sponsor.
- Neuralink WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian Roser, MD principal investigator
Cleveland Clinic Abu Dhabi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N1 Implant and R1 Robot in people with Tetraplegia/Tetraparesis and Quadriplegia, run by Neuralink Corp at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neuralink Clinical Team ((877) 398-4465, clinical-team-ct@neuralink.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of Device-Related Adverse Events (AE) (time frame: 12 months post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.