Precise Robotically IMplanted Brain-Computer InterfacE

Description

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.

Conditions

Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia, Tetraplegic; Paralysis

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Study Overview

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Study Details

Study 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.

PRIME: an Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for the Control of External Devices

Precise Robotically IMplanted Brain-Computer InterfacE

Condition
Tetraplegia/Tetraparesis
Intervention / Treatment

-

Contacts and Locations

Phoenix

Barrow Neurological Institute, Phoenix, Arizona, United States, 85013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

22 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neuralink Corp,

Francisco Ponce, MD, PRINCIPAL_INVESTIGATOR, Barrow Neurological Institute

Study Record Dates

2031-01