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

NCT06700304 | Recruiting DMC

• 1 other identifier: N1-EFS-002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

brain computer interface; Neuralink N1 Implant; Neuralink; Robot; tetraparesis; tetraplegia; quadriplegia; ALS; spinal cord injury; Amyotrophic lateral sclerosis; chip; brain chip; External device control; Wireless implant; Neuroprosthetics; SCI; paralysis

Outcome Measures

Primary Outcomes (2)

• The Rate of Device-Related Adverse Events (AE)

  12 months post-implant

• The Rate of Procedure-Related Adverse Events (AE)

  12 months post-implant

Secondary Outcomes (8)

• The Rate of Device-Related Adverse Events (AE)

  Up to 36 months post-implant

• The Rate of Procedure-Related Adverse Events (AE)

  Up to 36 months post-implant

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

  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

  From baseline to 36-months post-implantation

• Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study

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

Study Arms (1)

CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface

OTHER

Open label

Device: N1 Implant; Device: R1 Robot

Interventions

N1 Implant DEVICE

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

CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface

R1 Robot DEVICE

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

CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuralink Corp: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Links

• Neuralink Website

MeSH Terms

Conditions

Quadriplegia; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Neuralink Clinical Team

CONTACT

(877) 398-4465; clinical-team-ct@neuralink.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 21, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2030
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)