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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface | Other | Open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N1 Implant | Device | The N1 Implant is a type of implantable brain-computer interface. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Device-Related Adverse Events (AE) | 12 months post-implant | |
| The Rate of Procedure-Related Adverse Events (AE) | 12 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Device-Related Adverse Events (AE) | Up to 36 months post-implant | |
| The Rate of Procedure-Related Adverse Events (AE) | Up to 36 months post-implant | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neuralink Clinical Team | Contact | (877) 398-4465 | clinical-team-ct@neuralink.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| Label | URL |
|---|---|
| Neuralink Website | View source |
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The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)
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| R1 Robot | Device | The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant. |
|
| Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study |
| 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 | From baseline to 36-months post-implantation |
| Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study | 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 | From baseline to 36-months post-implantation |
| Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study | 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 | From baseline to 36-months post-implantation |
| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D000690 | Amyotrophic Lateral Sclerosis |
| D013119 | Spinal Cord Injuries |
| D010243 | Paralysis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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