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 Deep Brain Stimulation, or Virtual and augmented reality tasks. The registry lists allocation as randomized. Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.
They plan to enroll about 80 people at 2 sites. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
Interventions: Deep Brain Stimulation, Virtual and augmented reality tasks
Primary outcome (registry wording): Physiological change - eye-blinks