University of Pennsylvania
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).
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 br…
Inclusion Criteria: 1. Age 22-80 2. Meet DSM-V criteria for OCD ≥ 1 year with a Y-BOCS score ≥ 16 3. 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: 1. Co-morbid psychiatric disorder other than depression or anxiety disorder 2. Active suicidal risk (defined by C-SSRS) 3. History of neurological condition 4. Pregnant or breastfeeding, or planning to become pregnant during the study period
Low-intensity focused ultrasound (LIFU) will be administered using the Attune ATTN201 device. The intervention is targeted bilaterally to the Sub-thalamic Nucleus (STN) region of the brain. All participants receive 4 sessions in their assigned condition (active LIFU or Sham) and, if patient-level stopping criteria are not met, continue in that same assigned condition to a total of 8 sessions, twice weekly over approximately 4 weeks.
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