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

Last updated: May 27, 2025
Sponsor: Neuralink Corp
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Amyotrophic Lateral Sclerosis (Als)

Spinal Cord Disorders

Treatment

R1 Robot

N1 Implant

Clinical Study ID

NCT06700304
N1-EFS-002
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateralsclerosis (ALS) for at least 1 year without improvement, where quadriplegia isdefined as having very limited or no hand, wrist, and arm movement and all levelsbelow

  • Life expectancy ≥ 12 months.

  • Ability to communicate in English

  • Presence of a stable caregiver

Exclusion

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 yourability to safely participate in the study or undergo the implantation procedure

Study Design

Total Participants: 6
Treatment Group(s): 2
Primary Treatment: R1 Robot
Phase:
Study Start date:
November 20, 2024
Estimated Completion Date:
November 30, 2030

Connect with a study center

  • University Health Network

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.