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

NCT06700304 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-31

No results posted yet for this 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.

Conditions

  • Tetraplegia/Tetraparesis
  • Quadriplegia
  • Quadriplegia/Tetraplegia
  • Cervical Spinal Cord Injury
  • Amyotrophic Lateral Sclerosis (ALS)
  • Spinal Cord Injury (Quadraplegia)
  • Spinal Cord Injury

Interventions

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER
  • Neuralink Corp

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2027-11-30
Completion
2030-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06700304 on ClinicalTrials.gov