Actively Recruiting
CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Led by Neuralink Corp · Updated on 2025-05-31
6
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
N
Neuralink Corp
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and function of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs due to conditions like tetraplegia or tetraparesis. The study aims to understand how well this brain-computer interface and its robotic implantation system work in individuals who have severe movement impairments, including those with spinal cord injury or amyotrophic lateral sclerosis (ALS). The N1 Implant is a small, wireless device placed inside the skull and connected to tiny threads inserted into the brain by the R1 Robot, a machine designed to precisely implant these threads. This is an open-label study where participants receive the implant and robot-assisted procedure to explore the device's performance and safety over time. Participants will be closely monitored through multiple assessments over 12 months post-implant, including tracking device- and procedure-related adverse events. Cognitive and mental health evaluations using tools like the Montreal Cognitive Assessment (MoCA), Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder-7 (GAD-7) will be done at regular intervals up to 36 months. The study involves ongoing follow-up to assess long-term effects and safety.
CONDITIONS
Brief Title
CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement
- Life expectancy of at least 12 months
- Ability to communicate in English
- Presence of a stable caregiver
You will not qualify if you...
- 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 showing hemorrhage, tumor, distorted or adverse anatomy
- Any condition compromising safe participation or implantation as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo robotic implantation of the N1 brain-computer interface device using the R1 Robot.
1 implantation visit and several immediate post-operative visits
Duration - Up to 12 months post-implant
Participants are monitored for device- and procedure-related adverse events and cognitive and psychological assessments are conducted up to 12 months post-implantation.
Multiple visits including assessments at 3, 6, 9, and 12 months post-implantation
Duration - Up to 36 months post-implant
Participants continue to be monitored for safety and cognitive and psychological outcomes up to 36 months post-implantation.
Periodic visits up to 36 months post-implantation
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
N
Neuralink Clinical Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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