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SONATA LIFU for OCD

NCT07728994 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

  • Obsessive Compulsive Disorder

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-31
Completion
2028-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728994 on ClinicalTrials.gov