An interventional study of N1 Implant and R1 Robot in Tetraplegia/Tetraparesis, Quadriplegia and Quadriplegia/Tetraplegia, sponsored by Neuralink Corp. Recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Neuralink Corp · Not applicable, Interventional, and Other
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.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's planned enrollment of 10 is below the median of 15 across 193 interventional studies indexed under Quadriplegia.
Browse Quadriplegia studies →Neuralink Corp is the lead sponsor of 7 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open label
Device: N1 Implant · Device: R1 Robot
The N1 Implant is a type of implantable brain-computer interface.
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
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
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
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
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
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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
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
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.
Time frame: From baseline to 36-months post-implantation
Plan to share: No
Started May 2025 (actual). Primary completion is estimated for Nov 2026, 18 months after the start.
Of 97 interventional studies with no phase under Quadriplegia, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 309. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
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