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RECRUITINGINTERVENTIONAL

CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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 (1)

University Health Network
Toronto, Ontario, Canada