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

Neuralink Corp1 site in 1 country6 target enrollmentNovember 20, 2024

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tetraplegia/Tetraparesis
Sponsor: Neuralink Corp
Enrollment: 6
Locations: 1
Primary Endpoint: The Rate of Device-Related Adverse Events (AE)
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 20, 2024

End Date

November 30, 2030

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Neuralink Corp

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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 Outcomes

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 Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study(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(From baseline to 36-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 Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study(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(From baseline to 36-months post-implantation)
The Rate of Device-Related Adverse Events (AE)(Up to 36 months post-implant)