SONATA Dose Duration LIFU for OCD

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.

• ATTN201 - Low Intensity Focused Ultrasound (Device): 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.

Primary outcomes

• Participant Report of Symptoms [4 weeks]: The 22-item Participant Report of Symptoms questionnaire provides granular, visit-level characterization of tolerability and symptomatic response across the treatment course, complementing the primary tolerability endpoints.
• Visual Analog Scale [4 weeks]: The Visual Analog Scale, which assesses on a scale from 0-10 the participants obsessions, compulsions, distress, depression, energy and anxiety. This survey provides granular, visit-level characterization of tolerability and symptomatic response across the treatment course, complementing the primary tolerability endpoints.
• Beck Depression Inventory [4 weeks]: The Beck Depression Inventory (BDI-II)allows for monitoring of unintended effects on mood, given that the STN plays a role in emotional processing and provide a broader characterization of the clinical impact of treatment. The BDI-II is an assessment used to measure severity of depression
• Becks Anxiety Inventory [4 weeks]: The Becks Anxiety Inventory (BAI) allows for monitoring of unintended effects on anxiety, given that the STN plays a role in emotional processing and provide a broader characterization of the clinical impact of treatment. The BAI is an assessment used to measure clinical anxiety.
• Clinical Global Impression Scale [4 weeks.]: The Clinical Global Impression scale asks two questions; the severity of illness and the change in illness. This scale allows a clinician completed score to monitor unintended effects on mood and anxiety. The Clinical Global Impressions - Improvement (CGI-I) scale is used to measure how much a patient's illness has improved or worsened. The Clinical Global Impressions - Severity (CGI-S) is used to measure how severe the patient's illness is.

Sex: All, ages: 22 Years to 80 Years

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

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• Katherine Scangos, MD, PhD, Principal investigator, University of Pennsylvania