An interventional study of N1 Implant and R1 Robot in Tetraplegia/Tetraparesis, Quadriplegia and Cervical Spinal Cord Injury, sponsored by Neuralink Corp. Recruiting at 2 sites in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Neuralink Corp · Not applicable, Interventional, and Device feasibility
The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. 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.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's planned enrollment of 15 is close to 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.
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)
Time frame: 12 months post-implant
Procedure-Related Adverse Events (AE)
Time frame: 12 months post-implant
Device-Related Adverse Events (AE)
Time frame: Up to 72 months post-implant
Procedure-Related Adverse Events (AE)
Time frame: Up to 72 months post-implant
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Jun 2026, 29 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 29 months is below that.
How these figures are worked out, and which studies are left out of them.
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