OCD LIFU Target Engagement
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- University of Pennsylvania
- Study ID
- NCT07558148
- Status
- Recruiting
Conditions
- Obsessive Compulsive Disorder (OCD)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Low Intensity Focused Ultrasound — DEVICELow-intensity focused ultrasound (LIFU) will be administered using the Attune ATTN201 device. This intervention is characterized by a multifocal approach targeting three specific subcortical regions: the subthalamic nucleus (STN), the dorsal anterior cingulate cortex (dACC), and the ventral striatum (VS+). Unlike clinical treatment trials, this is a target-engagement pilot study where each participant receives single sessions of sonication at these specific coordinates to evaluate acute physiological and symptomatic changes. The intervention includes a within-subject sham-controlled component, where the device is positioned identically but no ultrasound energy is delivered.
Study Details
The investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when delivered to subcortical brain targets. The investigators will use the ATTN201 device to deliver single sessions of unfocused and focused ultrasound to up to three brain targets over 4 study visits and assess the intervention through self-rated scales of OCD symptoms.
Key Dates
- Start date
- Mar 4, 2026
- Status verified
- Apr 2026
- Primary completion
- May 19, 2026
- Completion
- May 19, 2026
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: LIFU Target Engagement GroupParticipants in this single experimental group will undergo a series of low-intensity focused ultrasound (LIFU) sessions to evaluate safety and target engagement. Each participant will receive active LIFU stimulation at up to three personalized corticostriatal brain targets. The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare physiological and clinical responses.
Primary Outcome Measure
Change in Symptom Intensity through VAS score [ Time Frame: From the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks. ]
Central Contacts
- Marshall Nambiar, MS215-746-8901
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Katherine Scangos, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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