Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT06700304

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

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University Health Network

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

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