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

Not Applicable

Recruiting

• Conditions: Tetraplegia/Tetraparesis; Quadriplegia; Quadriplegia/Tetraplegia; Cervical Spinal Cord Injury; Amyotrophic Lateral Sclerosis (ALS); Spinal Cord Injury (Quadraplegia); Spinal Cord Injury

• Registration Number: NCT06700304
• Lead Sponsor: Neuralink Corp

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study Start: 2024-11-20
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2027-11-30
• Study Completion: 2030-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The Rate of Device-Related Adverse Events (AE)	Up to 72 months post-implant
The Rate of Procedure-Related Adverse Events (AE)	Up to 72 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 72-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 72-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 72-months post-implantation

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada