RecruitingNot ApplicableNCT07558148

OCD LIFU Target Engagement

Pilot Study to Investigate Brain Targets for Neuromodulation in Obsessive-compulsive Disorder

Sponsor

University of Pennsylvania

Enrollment

10 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

Obsessive Compulsive Disorder (OCD)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria9

\. Participants must be enrolled in the IRB #853085 study
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Adults aged 18-60 years old
Chronic OCD (5 years preceding date of enrollment), diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
Presence of obsessions, compulsions, or both time-consuming obsessions and compulsions that take more than one hour a day or cause significant distress or impairment in social, occupation, or other important areas of functioning Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication) or another medical condition
Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5 Severe OCD symptoms, as defined by Y-BOCS I score of 28 or higher, within two weeks prior to enrollment
Compulsions need to involve movement of the hands and/or arms so that the sleeve is able to detect participant's actions (cannot be solely mental or verbal compulsions)
Ability to understand procedure-related instructions and to complete study assessments in English, and ability to comply with protocol requirements (e.g., procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), in the opinion of the Principal Investigator
Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s) 8 Willingness and ability to provide informed consent, in the opinion of the Principal Investigator

Exclusion Criteria15

An individual who meets any of the following criteria will be excluded from participation in this study:
Unable to undergo MRI scan
Presence of metallic implants or devices or tattoos
Claustrophobia or severe anxiety
Inability to remain still for duration of scan
Inability to fit and wear the ATTN201 device for the entire
Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study, or may affect the integrity of the study data
Pregnancy - this is an exclusion criterion because we will be intentionally increasing anxiety in participants to evaluate optimal strategies to provoke distress and then promote relaxation
Any past or present medical condition, disease, disorder, or injury that, in the opinion of the Principal Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may impact, compromise, or affect the integrity of the data or results of the study.
Have a previous injury or surgery which could affect the nerve distribution
Have nerve damage (neuropathy)
Have a diagnosed neuromuscular disorder
Have a pacemaker
Have a history of skin allergies, psoriasis eczema, dermatitis, or other skin inflammation conditions
Compulsions cannot be completely mental or verbal actions, such as repeating words, counting objects, or performing mental rituals, and cannot involve only facial muscles/actions such as blinking or staring

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICELow Intensity Focused Ultrasound

Low-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.