Precise Robotically IMplanted Brain-Computer InterfacE

Neuralink Corp15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Tetraplegia/Tetraparesis Quadriplegia Cervical Spinal Cord Injury Amyotrophic Lateral Sclerosis Quadriplegia/Tetraplegia

Interventions

N1 ImplantDEVICE

The N1 Implant is a type of implantable brain-computer interface

R1 RobotDEVICE

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Barrow Neurological Institute

Phoenix, Arizona, United States

RECRUITING

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Device-Related Adverse Events (AE)

Time frame: 12 months post-implant

Procedure-Related Adverse Events (AE)