Neuralink Corp
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.
Inclusion Criteria: ● A diagnosis of: (A) Spinal cord injury (SCI) for at least 12 months with a muscle power grade of ≤ 3/5 in all muscles of the arms and hands principally innervated by C6-T1 nerve roots at the time of screening AND the Investigator confirms that bilateral upper-limb weakness prevents reliable, independent use of standard digital-access devices. OR (B) Amyotrophic lateral sclerosis (ALS) with 1. Muscle power grade ≤4/5 at C5 in both arms; AND 2. Muscle power grade ≤3/5 in all muscles of both arms and hands principally innervated by C6-T1 nerve roots, except that strength a…
The N1 Implant is a type of implantable brain-computer interface
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.