An interventional study of N1 Implant and R1 Robot in Tetraplegia/Tetraparesis, Quadriplegia and Cervical Spinal Cord Injury, sponsored by Neuralink Corp. Recruiting at 1 site in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Neuralink Corp · Not applicable, Interventional, and Other
Among 122 studies in Quadriplegia with a site in United States — 43 open to participants now, 50 under way, 2 of them phase 3. Quadriplegia · United States.
Among the 122 studies in Quadriplegia with a site in United States, this one is the 81st largest by planned enrollment of the 111 interventional ones, is one of 10 that started in 2025, is one of 82 with no phase, reaches primary completion later than 39 of the 49 other live ones, and was the 113th registered.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's planned enrollment of 6 is below the median of 15 across 193 interventional studies indexed under Quadriplegia.
Browse Quadriplegia studies →43 of the 122 studies in Quadriplegia with a site in United States are open now, in 3 countries. 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: 22 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →122 studies; the count open now beside each. This study's row is marked.
First in 1989; this study’s year is marked. 10 started in 2025.
Median enrollment 14 across the 111 interventional studies, 34 across the 10 observational. Of the 61 that completed or were terminated, 29 (48%) have results posted.
21 of 122 have an industry lead sponsor. The 10 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.
16 of the studies in Quadriplegia with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07799532Phase 3NervGen PharmaA Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury | 2027-07 |
| NCT07625332Phase 3Northwell HealthPilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI) | 2027-08 |
| NCT05423600Virginia Commonwealth UniversityTransspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia | 2026-11 |
| NCT06295146University of PittsburghVirtual Peer Coaching in Manual Wheelchair Skills | 2026-12-30 |
| NCT05626816MetroHealth Medical CenterAcute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury | 2026-12-31 |
Among the 122 studies in Quadriplegia with a site in United States, from their registry updates:
The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
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.
Adults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.
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.
Implantation of the N1 Implant by the R1 Robot.
Device: N1 Implant · Device: R1 Robot
The N1 Implant is a type of implantable brain-computer interface
Also known as: Neuralink N1 Implant, N1, Telepathy, Link
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Also known as: R1, Neuralink R1 Robot
Device-Related Adverse Events (AE)
The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.
Time frame: 12 months post-implant
Procedure-Related Adverse Events (AE)
The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.
Time frame: 12 months post-implant
Long-term Device-Related Adverse Events (AE)
The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit.
Time frame: Up to 48 months post-implant
Long-term Procedure-Related Adverse Events (AE)
The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit.
Time frame: Up to 48 months post-implant
Preliminary efficacy of the R1 Robot
Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes).
Time frame: During surgical implantation procedure
Preliminary efficacy of the N1 Implant
Preliminary efficacy of the N1 Implant will be evaluated by measuring the following BCI performance for speech, quantified by measuring the monthly maximum correct word per minute (CWPM).
Time frame: Up to 48 months post-implant
Plan to share: No
Started Oct 2025 (actual). Primary completion is estimated for Oct 2028, 36 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 36 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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