CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
NCT06700304 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-05-31
Summary
The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.
Conditions
- Tetraplegia/Tetraparesis
- Quadriplegia
- Quadriplegia/Tetraplegia
- Cervical Spinal Cord Injury
- Amyotrophic Lateral Sclerosis (ALS)
- Spinal Cord Injury (Quadraplegia)
- Spinal Cord Injury
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.
Sponsors & Collaborators
-
University Health Network, Toronto
collaborator OTHER -
Neuralink Corp
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-20
- Primary Completion
- 2027-11-30
- Completion
- 2030-11-30
Countries
- Canada
Study Locations
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