Focused Ultrasound for Behavioral Health
This is a double-blind, within-participant crossover, multi-site dose-finding study evaluating the safety, feasibility, and preliminary efficacy of repeated low-intensity focused ultrasound (LIFU) stimulation using the ATTN201 device across seven candidate deep-brain targets in adults with subsyndromal-to-moderate depression, anxiety, or obsessive-compulsive disorder. Every session delivers active ATTN201 stimulation; there is no sham or placebo condition. Participants and the on-site study staff who deliver stimulation and administer the clinical scales are blinded to the brain target and to the stimulation parameters assigned for each session by a constrained Bayesian optimization algorithm.
Be between 22 and 80 years of age (inclusive) on the day of signing informed con... [+13]
Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (ideation with intent,... [+13]