Overview
This study is testing a new, non-invasive brain stimulation approach for adults with Obsessive Compulsive Disorder (OCD). Researchers are evaluating the safety, tolerability, and target engagement of low-intensity focused ultrasound (LIFU) directed at a brain region called the subthalamic nucleus (STN). The ultrasound is delivered using a wearable device called ATTN201 (developed by Attune Neurosciences).
Description
Twenty participants will take part in this randomized, sham-controlled trial. This means participants will be randomly assigned to receive either active LIFU or a sham (inactive) version of the treatment, and all participants will not know which one was given until the end of participation.
Participants will be seen multiple times a week for LIFU sessions, with a safety check completed halfway through the number of sessions. All participants will undergo MRI brain scans at the start of the study and at three follow-up checkpoints to help researchers understand how the treatment affects the brain.
Eligibility
Inclusion Criteria:
- Age 22-80
- Meet DSM-V criteria for OCD ≥ 1 year with a Y-BOCS score ≥ 16
- Must be on the same stable dose(s) of OCD medication for at least 4 weeks prior to screening and throughout the course of the study
Exclusion Criteria:
- Co-morbid psychiatric disorder other than depression or anxiety disorder
- Active suicidal risk (defined by C-SSRS)
- History of neurological condition
- Pregnant or breastfeeding, or planning to become pregnant during the study period
