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NCT Number: NCT06700304

CAN-PRIME: 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.

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Key information

Conditions

Tetraplegia/Tetraparesis Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS) Central Nervous System Diseases Cervical Spinal Cord Injury Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Quadriplegia/Tetraplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Spinal Cord Injury (Quadraplegia) TDP-43 Proteinopathies Trauma, Nervous System Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location status: Recruiting

Location contact

Dr. Andres Lozano

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N1 Implant

Device

The N1 Implant is a type of implantable brain-computer interface.

R1 Robot

Device

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Primary outcomes

  1. The Rate of Device-Related Adverse Events (AE)

    Time frame: 12 months post-implant

  2. The Rate of Procedure-Related Adverse Events (AE)

    Time frame: 12 months post-implant

Secondary outcomes

  1. The Rate of Device-Related Adverse Events (AE)

    Time frame: Up to 36 months post-implant

  2. The Rate of Procedure-Related Adverse Events (AE)

    Time frame: Up to 36 months post-implant

  3. Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study

    Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation

  4. Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase

    Time frame: From baseline to 36-months post-implantation

  5. 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

  6. 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

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Neuralink Clinical Team

CONTACT

[email protected]

(877) 398-4465

Sponsors and collaborators

Lead sponsor

Neuralink Corp

Industry

Collaborators

  • University Health Network, Toronto

Registry information

Official study title

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

Acronym: CAN-PRIME

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Nov 21, 2024
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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