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RECRUITING
NCT07728994
PHASE2

SONATA LIFU for OCD

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

Summary

The study tests ATTN201, an investigational non-invasive headband that delivers low-intensity focused ultrasound (LIFU) to the subthalamic nucleus (STN) as a treatment for obsessive-compulsive disorder (OCD). It's a randomized, double-blind, 1:1 (active: sham) study with 40 total participants spanning 12-16 weeks and 14 in-person and remote visits.

Official title: Safety and Feasibility Study of ATTN201 Repeated Subthalamic Nucleus Focused Ultrasound Stimulation for the Treatment of Obsessive Compulsive Disorder

Key Details

Gender

All

Age Range

22 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-07-01

Completion Date

2028-10-31

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

DEVICE

Low Intensity Focused Ultrasound

ATTN201 is an investigational, non-invasive, wearable headband containing two ultrasound transducers positioned over the temporal region of the skull. Guided by a pre-treatment MRI, the device delivers focused low-intensity ultrasound (LIFU) to the subthalamic nucleus (STN).

DEVICE

Sham (No Treatment)

Participants are fitted with the same ATTN201 headband used in the active arm, and the device is operated using the same procedures and audible output as active stimulation. However, the ultrasound is unfocused and does not deliver a therapeutic effect to the brain. This sham condition is designed to be indistinguishable from active stimulation to preserve blinding of participants and study staff.

Locations (1)

Attune Neurosciences

San Francisco, California, United States