Pilot Study of Low-Intensity Focused Ultrasound for Treating Symptoms of Obsessive-Compulsive Disorder in Adults

What this Trial Is About

Researchers are conducting a pilot study to evaluate the safety and feasibility of using low-intensity focused ultrasound LIFU to address symptoms of obsessive-compulsive disorder OCD. The study focuses on delivering ultrasound to specific subcortical brain targets and assesses its impact on OCD symptoms through self-rated scales. This within-subject, sham-controlled study aims to better understand physiological and symptomatic changes in adults aged 18 to 60 with chronic OCD. Participants will receive single sessions of active LIFU stimulation at up to three personalized brain targets the subthalamic nucleus, dorsal anterior cingulate cortex, and ventral striatum. The intervention uses the Attune ATTN201 device to deliver both active and sham placebo ultrasound across multiple visits. This multifocal approach involves up to 10 visits over approximately 6 weeks, including several intervention and sham sessions to compare effects. During the study, participants will attend up to 10 visits where various assessments will be performed, including self-rated OCD symptom scales, imaging before and after the intervention, and physiological measurements such as EMG, acceleration, angular velocity, and heart rate. Adverse events will be monitored immediately after and up to 24 hours following intervention sessions. The research team will evaluate changes in symptom intensity and brain imaging to understand the treatments impact over about 6 weeks.

OCD LIFU Target Engagement