A Phase 2 interventional study of ATTN201 - Low Intensity Focused Ultrasound in Obsessive - Compulsive Disorder, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Pennsylvania · Phase 2, Interventional, and Device feasibility
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 brain.
366 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.
This study's planned enrollment of 20 is below the median of 37 across 305 interventional studies indexed under Compulsive Personality Disorder.
Browse Compulsive Personality Disorder studies →University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive low intensity focused ultrasound stimulation
Device: ATTN201 - Low Intensity Focused Ultrasound
Participants received unfocused ultrasound, which mimic the auditory and peripheral sensations of active stimulation without delivering meaningful pressure to the brain target
Device: ATTN201 - Low Intensity Focused Ultrasound
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.
Participant Report of Symptoms
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.
Time frame: 4 weeks
Visual Analog Scale
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.
Time frame: 4 weeks
Beck Depression Inventory
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
Time frame: 4 weeks
Becks Anxiety Inventory
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.
Time frame: 4 weeks
Clinical Global Impression Scale
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.
Time frame: 4 weeks.
Plan to share: No — Individual participant data (IPD) will not be shared with outside researchers at this time to ensure the protection of participant privacy and to maintain strict compliance with the University of Pennsylvania Institutional Review Board (IRB) approved protocol.
Started Sep 2026 (actual). Primary completion is estimated for Jun 2028, 21 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Compulsive Personality Disorder →