Imaging-Guided Low Intensity Focused Ultrasound (LIFU) Neuromodulation of Ventral Striatum in Obsessive-Compulsive Disorder (OCD)
This research study is to investigate the safety, feasibility, and possible therapeutic benefits of a technology called Low Intensity Focused Ultrasound (LIFU) in patients with obsessive- compulsive disorder (OCD). The device used in this study transmits high frequency sound waves to a particular region of the brain called the Ventral Striatum (VS). LIFU is a non-invasive form of stimulation, which can be used to stimulate deep regions of the brain. In this study, the investigators will administer LIFU to activate the VS area of the brain while also observing this brain stimulation with an MRI machine. Other aims of this study include learning more about the patterns of brain activity associated with OCD and seeing if brain activity changes as symptoms of OCD change over time during the two weeks of LIFU stimulation. Participants in this study will be asked to perform computer administered behavioral tasks -- similar to simple computer games -- to examine whether certain features of OCD (e.g., avoidance of feared triggers) change over the course of LIFU stimulation. The treatment phase of this research study is expected to last two weeks with three weekly (total of 6) treatment sessions all carried at the MRI brain imaging center at Baylor College of Medicine. There will be at least one additional screening visit before treatment starts and a series of follow up visits over a six-month period.
• 1\. Outpatients, males and females, 21-55 years of age.
• 2\. Principal diagnosis of OCD according to the DSM-5 with duration of ≥2 years.
• 3\. Subjects with at least moderate OCD, defined by Yale-Brown Obsessive Compulsive Scale (YBOCS) (27) score of \>19.
• 4\. Had trials of at least two SSRIs or one SSRI and clomipramine.
‣ Treatment failure/non-response: As per the MGH-TRQ-OCD, minimal or no meaningful clinical benefit despite an adequate dose and duration of treatment;
⁃ Adequate duration: At least 8 weeks of treatment with SSRI or clomipramine
⁃ Adequate dose: Defined by the USPI labeling
• 5\. If on medication, must be maintained on SRI medications at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
• 6\. If subjects are currently undergoing Exposure and Response Prevention (ERP) treatment, they must be in the maintenance stage with stable ERP dosing for at least 2 months.
• 7\. Willing and able to adhere to the study schedule, which requires 6 sonication/scan visits over two weeks and follow up visits for up to 6 months.