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Recruiting NCT06700304

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

No phase Interventional Tetraplegia/Tetraparesis Quadriplegia Quadriplegia/Tetraplegia Cervical Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N1 Implant, R1 Robot.
Who it may be relevant to
Registry conditions: Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • The Rate of Device-Related Adverse Events (AE) [Time frame: 12 months post-implant]
  • The Rate of Procedure-Related Adverse Events (AE) [Time frame: 12 months post-implant]
Secondary outcome measures (8)
  • The Rate of Device-Related Adverse Events (AE) [Time frame: Up to 36 months post-implant]
  • The Rate of Procedure-Related Adverse Events (AE) [Time frame: Up to 36 months post-implant]
  • Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study [Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation]
  • Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase [Time frame: From baseline to 36-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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Canada · 1 center
  • University Health Network — Toronto

Identifiers

NCT: NCT06700304 · N1-EFS-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗