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

May 27, 2025 updated by: Neuralink Corp

CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network
        • Principal Investigator:
          • Dr. Andres Lozano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
  • Life expectancy ≥ 12 months.
  • Ability to communicate in English
  • Presence of a stable caregiver

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 your ability to safely participate in the study or undergo the implantation procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface
Open label
Device: R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Device: N1 Implant
The N1 Implant is a type of implantable brain-computer interface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Rate of Device-Related Adverse Events (AE)
Time Frame: 12 months post-implant
12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time Frame: 12 months post-implant
12 months post-implant

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
Time Frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
Time Frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
Time Frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
From baseline to 3-, 6-, 9-, and 12-months post-implantation
The Rate of Device-Related Adverse Events (AE)
Time Frame: Up to 36 months post-implant
Up to 36 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time Frame: Up to 36 months post-implant
Up to 36 months post-implant
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
Time Frame: From baseline to 36-months post-implantation
From baseline to 36-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
Time Frame: From baseline to 36-months post-implantation
From baseline to 36-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
Time Frame: From baseline to 36-months post-implantation
From baseline to 36-months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuralink Corp

Collaborators

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2030

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N1-EFS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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