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| Name | Class |
|---|---|
| Attune Neurosciences Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Unable to undergo MRI scan
Inability to fit and wear the ATTN201 device for the entire
Exclusion criteria for IRB study #853085 include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marshall Nambiar, MS | Contact | 215-746-8901 | marshall.nambiar@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katherine Scangos, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
Individual participant data (IPD) will not be shared with outside researchers at this time to ensure the protection of participant privacy and to maintain strict compliance with the University of Pennsylvania Institutional Review Board (IRB) approved protocol.
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| 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 | 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. | From the first baseline visit (Visit 1) through the final visit (Visit 10). |
| 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. | 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 | 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. | 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) | This outcome evaluates changes in heart rate activity using photoplethysmography (PPG) recorded during sessions. PPG signals will be collected from sensors placed on the participant and processed using standardized pipelines. Changes in physiological response will be assessed by comparing pre to post-sonication values. | Baseline through end of intervention period (Visits 2-9), with PPG data collected at every in-person visit, approximately 6 weeks. |