protocolSection identificationModule nctId: NCT06273904, orgStudyIdInfo id: Pro00132631, briefTitle: Modulating Escape Using Focused Ultrasound, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, descriptionModule briefSummary: This is a study to find out if a cutting-edge technology called transcranial focused ultrasound (tFUS) can be used to treat how people with anxiety or related concerns cope with emotional situations. tFUS is a brain stimulation technology that causes temporary changes in the activity of deep brain areas without a need for any surgery or other permanent or invasive procedures.This study is recruiting participants who recently started treatment for anxiety or a related concern to come in for 3 visits at the Medical University of South Carolina. At the first visit, participants will do interviews and surveys asking about anxiety and related concerns, and they do tasks where they respond to emotional pictures while brain activity is measured using magnetic resonance imaging (MRI). At the next two visits, participants again do a task where they see and react to emotional images, and this time the task is done once before and again once after receiving tFUS that either actively causes temporary changes (lasting for about an hour) in a targeted brain area or is not active (no changes elicited). At each tFUS visit, responses are measured with sensors worn on the hand, arms, face, and head (these visits do not involve MRI).Each visit in this study is expected to last between 2 - 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time., conditionsModule conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Active transcranial focused ultrasound (tFUS), interventions name: Sham transcranial focused ultrasound (tFUS), outcomesModule primaryOutcomes measure: Change in Fear-Potentiated Startle Reflex, secondaryOutcomes measure: Change in speed to initiate avoidance behavior, secondaryOutcomes measure: Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation, secondaryOutcomes measure: Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment, secondaryOutcomes measure: Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks, secondaryOutcomes measure: Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia, secondaryOutcomes measure: Change in Task-Based Heart Rate (Beats per Minute) Changes, secondaryOutcomes measure: Change in Task-Based Galvanic Skin Conductance, secondaryOutcomes measure: Change in State Anxiety During Session, otherOutcomes measure: Task-Related Regional Brain Activation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False