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RECRUITING
NCT06429735
NA

Precise Robotically IMplanted Brain-Computer InterfacE

Sponsor: Neuralink Corp

View on ClinicalTrials.gov

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.

Official title: PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Key Details

Gender

All

Age Range

22 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-01-09

Completion Date

2031-01

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DEVICE

N1 Implant

The N1 Implant is a type of implantable brain-computer interface

DEVICE

R1 Robot

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Locations (2)

Barrow Neurological Institute

Phoenix, Arizona, United States

University of Miami

Miami, Florida, United States