Clinical Trial

Precise Robotically IMplanted Brain-Computer InterfacE

Study acronym: PRIME
Recruiting
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Record status
This record was last updated January 9, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2024-05-21; most recent amendment 2026-01-07.
Trial Details
NCT Number NCT06429735
Lead Sponsor Neuralink Corp
Conditions Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia, Tetraplegic; Paralysis
Enrollment 15 participants
Start Date 2024-01-09
Primary Completion 2026-06 (estimated)
Study Completion 2031-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-09