Clinical trial NCT06700304: CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Official title: CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Neuralink Corp
Sponsor class: INDUSTRY
Collaborators: name: University Health Network, Toronto
First posted: 2024-11-21
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: The Rate of Device-Related Adverse Events (AE)
timeFrame: 12 months post-implant
measure: The Rate of Procedure-Related Adverse Events (AE)
timeFrame: 12 months post-implant
Secondary outcomes:
measure: The Rate of Device-Related Adverse Events (AE)
timeFrame: Up to 36 months post-implant
measure: The Rate of Procedure-Related Adverse Events (AE)
timeFrame: Up to 36 months post-implant
measure: Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
timeFrame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
measure: Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
timeFrame: From baseline to 36-months post-implantation
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
timeFrame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
timeFrame: From baseline to 36-months post-implantation
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
timeFrame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
timeFrame: From baseline to 36-months post-implantation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: