RecruitingPhase 2NCT07728994

SONATA LIFU for OCD

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

Sponsor

University of Pennsylvania

Enrollment

40 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Obsessive-Compulsive Disorder

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.

Eligibility

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Low Intensity Focused Ultrasound and a medical device called Sham (No Treatment) for people with obsessive-compulsive disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELow 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).

DEVICESham (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.