Precise Robotically IMplanted Brain-Computer InterfacE (PRIME)

Neuralink Corp

Status

Enrolling

Conditions

Amyotrophic Lateral Sclerosis

Quadriplegia

Cervical Spinal Cord Injury

Tetraplegia/Tetraparesis

Quadriplegia/Tetraplegia

Tetraplegic; Paralysis

Treatments

Device: R1 Robot

Device: N1 Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT06429735

N1-EFS-001

Details and patient eligibility

About

The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.

Enrollment

5 estimated patients

Sex

All

Ages

22 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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