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

Neuralink Corp

Status

Enrolling

Conditions

Spinal Cord Injury (Quadraplegia)

Quadriplegia

Amyotrophic Lateral Sclerosis (ALS)

Cervical Spinal Cord Injury

Tetraplegia/Tetraparesis

Spinal Cord Injury

Quadriplegia/Tetraplegia

Treatments

Device: R1 Robot

Device: N1 Implant

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06700304

N1-EFS-002

Details and patient eligibility

About

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.

Enrollment

6 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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