OCD LIFU Target Engagement Study
This study is looking at a new way to treat Obsessive Compulsive Disorder (OCD) using Low-Intensity Focused Ultrasound (LIFU). Researchers want to see if LIFU, delivered using the Attune ATTN201 device to specific areas of the brain (subthalamic nucleus, dorsal anterior cingulate cortex, and ventral...), is safe and helps reduce OCD symptoms. They will measure changes in your symptoms using a score and look at brain images before and after the treatment. This is a small study planning to include 10 participants between 18 and 60 years old. The current recruitment status is unclear.
- Study design
- This is an interventional pilot study involving 10 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would have approximately 10 visits over 6 weeks, including ultrasound sessions and symptom assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your symptoms will be monitored for approximately 6 weeks, from your first to your final visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
OCD LIFU Target Engagement
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Katherine Scangos, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Change in Symptom Intensity through VAS scoreFrom the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks.
This outcome evaluates the change in symptom intensity using Visual Analog Scales (VAS) scores. VAS include questions regarding urges to compulse/resist compulsions and subjective units of distress (SUDs), measure the intensity of a patient's impulse to carry out or control and inhibit these compulsions, and the amount of distress they feel, and are on a scale between 0-100, where higher scores signify greater symptom severity.
- Changes in Imaging between Pre- and Post-InterventionBefore the first visit (Visit 1) and after the final visit (Visit 10), approximately 6 weeks
This outcome measure evaluates safety and efficacy through neuroimaging conducted prior to and following the intervention. These measures are intended to assess potential effects and target engagement associated with LIFU. Efficacy measures will include changes in MRI-derived metrics (e.g., functional connectivity and/or regional activation in predefined regions of interest associated with the stimulation target). Safety is assessed by the presence of new or worsening structural abnormalities, including edema, hemorrhage, or tissue injury.
- Incidence of Adverse Events Assesed by Symptom ChecklistImmediately after each intervention session and up to 24 hours post-intervention, assessed across the intervention period (Visits 6-9).
This outcome measure evaluates the incidence and severity of adverse events using a structured symptomatic checklist survey administered throughout the study period. The checklist captures the presence, frequency, and severity of potential adverse symptoms. Adverse events will be categorized by type, relatedness, and severity.