Amyotrophic Lateral Sclerosis (ALS), Cervical Spinal Cord Injury, Quadriplegia, Quadriplegia/Tetraplegia, Spinal Cord Injury, Spinal Cord Injury (Quadraplegia), Tetraplegia/Tetraparesis
Conditions
Keywords
brain computer interface, Neuralink N1 Implant, Neuralink, Robot, tetraparesis, tetraplegia, quadriplegia, ALS, spinal cord injury, Amyotrophic lateral sclerosis, chip, brain chip, External device control, Wireless implant, Neuroprosthetics, SCI, paralysis
Brief 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.
Interventions
DEVICEN1 Implant
The N1 Implant is a type of implantable brain-computer interface.
DEVICER1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Sponsors
University Health Network, Toronto
Neuralink Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below * Life expectancy ≥ 12 months. * Ability to communicate in English * Presence of a stable caregiver
Exclusion criteria
* Moderate to high risk for serious perioperative adverse events * Active implanted devices * Morbid obesity (Body Mass Index \> 40) * History of poorly controlled seizures or epilepsy * History of poorly controlled diabetes * Requires magnetic resonance imaging (MRI) for any ongoing medical conditions * Acquired or hereditary immunosuppression * Use of smoking tobacco or other tobacco products * Psychiatric or psychological disorder * Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy. * Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Canada
Contacts
Primary ContactNeuralink Clinical Team
Outcome results
None listed