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NOT YET RECRUITING
NCT07851038
NA

Focused Ultrasound for Behavioral Health

Sponsor: Attune Neurosciences Inc

View on ClinicalTrials.gov

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.

Official title: Bayesian-Optimized Dose-Finding of ATTN201 Focused Ultrasound for Behavioral Health

Key Details

Gender

All

Age Range

22 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-10-05

Completion Date

2028-05-17

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DEVICE

ATTN201 head-worn focused ultrasound

ATTN201 head-worn focused ultrasound

Locations (1)

Attune Neurosciences, Inc.

San Francisco, California, United States