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.
This is a randomized, double-blind, sham-controlled study evaluating the safety and feasibility of ATTN201, an investigational, non-invasive, wearable ultrasound headband, in adults with obsessive-compulsive disorder (OCD). ATTN201 uses low-intensity focused ultrasound (LIFU), guided by magnetic resonance imaging (MRI), to deliver stimulation to the subthalamic nucleus (STN), a brain region implicated in OCD symptom circuits. This is the fifth study in which ATTN201 has been used in humans, and the device is not currently approved by the U.S. Food and Drug Administration (FDA) for clinical use outside of research. Approximately 40 participants will be enrolled in this study, ages 18-80, will be enrolled at a single site in San Francisco. Participants will be randomly assigned in a 1:1 ratio to receive either active focused ultrasound stimulation (20 participants) or sham (inactive) stimulation (20 participants). Sham stimulation sounds the same as active stimulation but does not deliver a therapeutic ultrasound effect to the brain. Neither participants nor the study staff administering treatment will know which group a participant has been assigned to during the treatment period. Participation lasts approximately 12 to 16 weeks and includes 14 in-person and remote visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
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).
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.
Attune Neurosciences
San Francisco, California, United States
RECRUITINGChange in OCD symptom severity
Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: up to 3 months
Incidence and severity of adverse events
Device-related and procedure-related side effects
Time frame: up to 3 months
Change in Anxiety Symptoms
Beck Anxiety Inventory
Time frame: up to 3 months
Change in depressive symptoms
Beck Depression Inventory - II (BDI-II)
Time frame: up to 3 months
Change in global impression
Clinical global impression severity and clinical global impression improvement
Time frame: up to 3 months
Change in functional disability
Sheehan Disability Scale
Time frame: up to 3 months
session-level symptom change
Visual Analog Scale ratings collected at each study intervention session
Time frame: up to 3 months
Change in resting-state and task based functional connectivity
fMRI
Time frame: up to 3 months
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