Actively Recruiting
CAN-PRIME: 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
314 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
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.
CONDITIONS
Official 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, with very limited or no hand, wrist, and arm movement and all levels below
- 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 that could compromise safe participation or implantation procedure as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
N
Neuralink Clinical Team
CONTACT
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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