OCD LIFU Target Engagement

NCT07558148 | Recruiting FDA Device

• 1 other identifier: 25-0707
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

OCD; LIFU

Outcome Measures

Primary Outcomes (3)

• Change in Symptom Intensity through VAS score

  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.

  From the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks.

• Changes in Imaging between Pre- and Post-Intervention

  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.

  Before the first visit (Visit 1) and after the final visit (Visit 10), approximately 6 weeks

• Incidence of Adverse Events Assesed by Symptom Checklist

  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.

  Immediately after each intervention session and up to 24 hours post-intervention, assessed across the intervention period (Visits 6-9).

Secondary Outcomes (5)

• Physiological Changes Measured by EMG

  Baseline through end of intervention period (Visits 2-9), with EMG data collected at every in-person visit, approximately 4 weeks.

• Change in Y-BOCS score after sonication

  From the first baseline visit (Visit 1) through the final visit (Visit 10).

• Change in Acceleration Measured by IMU

  Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.

• Change in Angular Velocity Measured by IMU

  Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.

• Change in Heart Rate Assessed by Photoplethysmography (PPG)

  Baseline through end of intervention period (Visits 2-9), with PPG data collected at every in-person visit, approximately 6 weeks.

Study Arms (1)

LIFU Target Engagement Group

EXPERIMENTAL

Participants 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.

Device: Low Intensity Focused Ultrasound

Interventions

Low Intensity Focused Ultrasound DEVICE

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.

Also known as: LIFU

LIFU Target Engagement Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Attune Neurosciences Inc: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Katherine Scangos, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marshall Nambiar, MS

CONTACT

215-746-8901; marshall.nambiar@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor CE of Psychiatry

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 30, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): May 19, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)