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.
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Device-Related Adverse Events (AE)
Timeframe: 12 months post-implant
Procedure-Related Adverse Events (AE)
Timeframe: 12 months post-implant