An interventional study of N1 Implant and R1 Robot in Tetraplegia/Tetraparesis, Quadriplegia and Quadriplegia/Tetraplegia, sponsored by Neuralink Corp. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Neuralink Corp · Not applicable, Interventional, and Device feasibility
Among 11 studies in Quadriplegia with a site in United Kingdom — 2 open to participants now, 2 under way, none of them phase 3. Quadriplegia · United Kingdom.
Among the 11 studies in Quadriplegia with a site in United Kingdom, this one is the 8th largest by planned enrollment, is one of 2 that started in 2025, is one of 10 with no phase, and was the 10th registered.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's planned enrollment of 7 is below the median of 15 across 193 interventional studies indexed under Quadriplegia.
Browse Quadriplegia studies →2 of the 11 studies in Quadriplegia with a site in United Kingdom are open now, in 1 country. Each count lists the studies.
Of the 57 Quadriplegia studies recruiting now, 17 (30%) set no upper age limit and 28 (49%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2025.
Median enrollment 10 across the 11 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
2 of 11 have an industry lead sponsor. The 8 most frequent:
Neuralink Corp is the lead sponsor of 7 studies on the registry; 7 are open to participants now.
Neuralink Corp has 7 studies filed under Quadriplegia — fewer than ten, so there is no comparison to draw.
1 of the studies in Quadriplegia with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07208188NHS Greater Glasgow and ClydetESCS for Upper Limb Rehab in Spinal Cord Injury | 2027-10 |
Among the 11 studies in Quadriplegia with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
The GB-PRIME Study is an early feasibility study designed to assess the 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.
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 participants treating neurologist that the disease will progress such that the participant will meet 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 48 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: Up to 48 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 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 48-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 1-, 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 48-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 1-, 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 48-months post-implantation
Plan to share: Undecided
Started Jul 2025 (actual). Primary completion is estimated for Jan 2028, 30 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 30 months is below that.
How these figures are worked out, and which studies are left out of them.
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