Overview
The purpose of this study is to evaluate the safety and preliminary effectiveness of the N1 System, a fully implanted brain-computer interface placed in the motor cortex with the R1 Robot. The study builds on knowledge gained in a previous clinical investigation of this system. It enrolls adults with severe upper-limb impairment from spinal cord injury, amyotrophic lateral sclerosis (ALS), or chronic ischemic stroke. Participants use neural signals recorded by the N1 Implant to control a computer cursor or virtual keyboard. The study will describe serious adverse device effects and will assess digital daily activities, computer-control performance, independent use of the system, and participant-, clinician-, and caregiver-reported outcomes. Up to 10 participants will be enrolled at up to five sites in the United States and followed for about 2 years after implantation, or about 3 years if they choose extended follow-up. There is no comparison group; each participant's results are compared with their own baseline.
Eligibility
Inclusion Criteria:
Adults with a diagnosis of ALS, spinal cord injury or chronic ischemic stroke who have severe weakness in the arms and hands that limits independent use of a computer or phone.
- Stable medical, physical and psychological condition
- Ability to communicate verbally or with a communication aid
- A caregiver available when daily support is needed
Exclusion Criteria:
- Morbid obesity (Body Mass Index \> 40)
- History of poorly controlled seizures or epilepsy
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
- Prior brain implant or active implanted medical device
- Psychiatric disorder or cognitive impairment
- Recent heart attack or cardiac arrest
- Blood thinners that cannot be paused for surgery
- Brain MRI or CT demonstrating hemorrhage, tumor, or 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
