Obsessive Compulsive Disorder (OCD)
Conditions
Keywords
OCD, LIFU
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.
Interventions
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.
Sponsors
University of Pennsylvania
Attune Neurosciences Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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: 1. Adults aged 18-60 years old 2. Chronic OCD (5 years preceding date of enrollment), diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5) 3. 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 4. 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 5. 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) 6. 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 7. 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: 1. 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 2. Inability to fit and wear the ATTN201 device for the entire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Intensity through VAS score | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Change in Y-BOCS score after sonication | From the first baseline visit (Visit 1) through the final visit (Visit 10). | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
Countries
United States
Contacts
CONTACTMarshall Nambiar, MS
PRINCIPAL_INVESTIGATORKatherine Scangos, MD, PhD
University of Pennsylvania
Outcome results
None listed