Safety and Feasibility Study of ATTN201 Repeated Subthalamic Nucleus Focused Ultrasound Stimulation for the Treatment of Obsessive Compulsive Disorder
University of Pennsylvania
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.
Description
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…
Eligibility
- Age range
- 22–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Have a principal diagnosis of OCD according to the DSM-5 with duration of \> 1 year 2. Have a Y-BOCS of \> 16 3. Participants currently on OCD medication must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating psychiatrist through the duration of the study. 4. Be between 22 to 80 years of age (inclusive) on the day of signing informed consent. 5. Be able and willing to undergo a cranial MRI 6. Be able and willing to wear an Attune device throughout the exp…
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.
Location
- Attune NeurosciencesSan Francisco, California