NCT07558148 · University of Pennsylvania
OCD LIFU Target Engagement
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Low 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.
Primary outcome measures
Change in Symptom Intensity through VAS score
Time frame: From 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-Intervention
Time frame: Before 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 Checklist
Time frame: Immediately 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\. Participants must be enrolled in the IRB #853085 study The inclusion criteria for the IRB #853085 study, which are also included in this trial are: 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 criteria
- 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 Exclusion criteria for IRB study #853085 include:
- 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
Where
- Philadelphia, Pennsylvania
Collaborators
Attune Neurosciences Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations