Precise Robotically IMplanted Brain-Computer InterfacE

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