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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
The N1 Implant is a type of implantable brain-computer interface.
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
University Health Network
Toronto, Ontario, Canada
RECRUITINGThe Rate of Device-Related Adverse Events (AE)
Time frame: 12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: 12 months post-implant
The Rate of Device-Related Adverse Events (AE)
Time frame: Up to 36 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: Up to 36 months post-implant
Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
Time frame: From baseline to 36-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
Time frame: From baseline to 36-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
Time frame: From baseline to 36-months post-implantation
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