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. The VOICE Study is an early feasibility study to measure the initial clinical safety and how well it works of the N1 and R1 Systems device design concept in providing an ability to communicate.
They plan to enroll about 6 people at Dallas. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
Interventions: N1 Implant, R1 Robot
Primary outcome (registry wording): Device-Related Adverse Events (AE)