Life sciences · Interventional Study
ClinicalTrials.gov · October 1, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07851038). This is a study registration, not published results. Lead sponsor: Attune Neurosciences Inc. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Depression, Anxiety, Obsessive Compulsive Disorder (OCD). Interventions: DEVICE: ATTN201 head-worn focused ultrasound. Primary outcome measures: Patient-specific transdiagnostic score (TDx) at 1 week after stimulation , 1 week after each stimulation session. Brief summary: 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.