What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are N1 Implant, or R1 Robot. The registry lists allocation as na. This study wants to measure the safety and preliminary effectiveness of the N1 System, a fully implanted brain-computer interface placed in the motor cortex with the R1 Robot.
They plan to enroll about 10 people at Miami. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for Neural Control of External Devices in Spinal Cord Injury, Amyotrophic Lateral Sclerosis, and Chronic Ischemic Stroke
Interventions: N1 Implant, R1 Robot
Primary outcome (registry wording): Serious adverse device effects (SADEs)