OCD LIFU Target Engagement
ConditionObsessive Compulsive Disorder (OCD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Pennsylvania
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: LIFU Target Engagement GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks.2
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.
Time frame
Before the first visit (Visit 1) and after the final visit (Visit 10), approximately 6 weeks3
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.
Time frame
Immediately after each intervention session and up to 24 hours post-intervention, assessed across the intervention period (Visits 6-9).Secondary outcomes
1
Physiological Changes Measured by EMG
This outcome measure evaluates changes in muscle activity using surface electromyography (EMG) recorded from the forearm during sessions. EMG signals will be collected continuously and processed using standardized pipelines. Metrics will include various features (e.g., SNR (dB)) over defined time windows. Change in muscle activity will be assessed by comparing pre-sonication values to post-sonication values.
Time frame
Baseline through end of intervention period (Visits 2-9), with EMG data collected at every in-person visit, approximately 4 weeks.2
Change in Y-BOCS score after sonication
This outcome measures changes in Obsessive-Compulsive symptom severity using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), administered by a trained clinician. Scores range from 0-40, with higher scores representing greater symptom severity.
Time frame
From the first baseline visit (Visit 1) through the final visit (Visit 10).3
Change in Acceleration Measured by IMU
This outcome measure evaluates changes in forearm movement amplitude using inertial measurement unit (IMU)-derived acceleration data. Acceleration (m/s²) will be recorded continuously from a microcontroller-based IMU placed on the participant's forearm during in-person sessions and processed using standardized signal processing pipelines. Change in movement amplitude will be assessed by comparing pre-sonication and post-sonication values.
Time frame
Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.4
Change in Angular Velocity Measured by IMU
This outcome measure evaluates changes in forearm rotational movement using inertial measurement unit (IMU)-derived angular velocity data. Angular velocity (°/s) will be recorded continuously from a microcontroller-based IMU placed on the participant's forearm during in-person sessions and processed using standardized signal processing pipelines. Change in rotational movement will be assessed by comparing pre-sonication and post-sonication values.
Time frame
Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
Attune Neurosciences Inc
Collaborator
Source ClinicalTrials.gov