[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05120635":3,"trial-entities:NCT05120635":118,"trial-summary:NCT05120635":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":43,"secondary_outcomes":57,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":76,"locations":79,"central_contacts":110,"overall_officials":113,"references":116,"see_also_links":117},"NCT05120635","PRO00118015","Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans","RECRUITING","2027-05-31","2026-08","2026-08-31","2021-10-01","Duke University","OTHER",false,"Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.\n\nThe purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.",null,[18,19,20,21],"Fear","GAD","Emotional Memory","PTSD",[],"INTERVENTIONAL","BASIC_SCIENCE",[26],"NA",{"count":28,"type":29},80,"ESTIMATED",[31,38],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Deep Brain Stimulation","Deep brain stimulation will be used",[36,37],"EMU Participants","RNS Participants",{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Virtual and augmented reality tasks","Virtual and augmented reality tasks will be used.",[36,37],[44,48,51,54],{"measure":45,"description":46,"timeFrame":47},"Physiological change - eye-blinks","Eye blinks will be measured using an eye tracking device and will be measure in blinks per second.","during the intervention\u002Fbehavioral tasks with and without stimulation",{"measure":49,"description":50,"timeFrame":47},"Physiological change - heart rate variability","heart rate variability will be measured in milliseconds.",{"measure":52,"description":53,"timeFrame":47},"Physiological change - skin conductance","Skin conductance will be measured in microSiemens.",{"measure":55,"description":56,"timeFrame":47},"Neurophysiological activity","Neurophysiological activity will be measured in Hz",[],"ALL","18 Years","70 Years",true,{"inclusion":63,"exclusion":68,"raw_text":75},[64,65,66,67],"18 years of age or older","Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement","Willing to provide informed consent and participate in the study","Ability to read and write English fluently",[69,70,71,72,73,74],"Unwilling to provide informed consent","Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement","Pregnant women","Participants with active psychosis","Participants with suicidal ideation","Participants with substance abuse issues","Inclusion Criteria:\n\n* 18 years of age or older\n* Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement\n* Willing to provide informed consent and participate in the study\n* Ability to read and write English fluently\n\nExclusion Criteria:\n\n* Unwilling to provide informed consent\n* Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement\n* Pregnant women\n* Participants with active psychosis\n* Participants with suicidal ideation\n* Participants with substance abuse issues",[77,78],"ADULT","OLDER_ADULT",[80,95],{"facility":81,"status":7,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":92},"University of California Los Angeles","Los Angeles","California","90024","United States",[87],{"name":88,"role":89,"phone":90,"email":91},"Sonja Hiller","CONTACT","9196812577","suthanalab@mednet.ucla.edu",{"lat":93,"lon":94},34.05223,-118.24368,{"facility":96,"status":7,"city":97,"state":98,"zip":99,"country":85,"contacts":100,"geoPoint":107},"Duke University Health System","Durham","North Carolina","27705",[101,104],{"name":102,"role":89,"phone":90,"email":103},"Gabriela Vilchez","suthanalab@duke.edu",{"name":105,"role":106},"Nanthia Suthana, PhD","PRINCIPAL_INVESTIGATOR",{"lat":108,"lon":109},35.99403,-78.89862,[111],{"name":112,"role":89,"phone":90,"email":103},"Aaron Halvorsen, PhD",[114],{"name":105,"affiliation":115,"role":106},"Duke Health",[],[],{"nct_id":4,"conditions":119,"biomarkers":122},[20,18,120,121],"Generalized Anxiety Disorder","Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":61,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This interventional study plans to enroll 80 participants. It is not specified if the study is randomized or blinded.","completed","Understanding Fear and Anxiety with Deep Brain Stimulation and Virtual Reality","This study aims to understand how the brain creates fear and anxiety, especially in conditions like PTSD (Post-Traumatic Stress Disorder) and GAD (Generalized Anxiety Disorder). You could be eligible if you are 18 to 70 years old, can read and write English, and have already had acute depth or chronic responsive neurostimulation (RNS) electrodes placed in your brain. Participants will complete tasks on a computer, some using a virtual reality headset, which will show different fear-provoking images. During these tasks, researchers will measure your brain activity, heart rate, and skin perspiration (sweat). The goal is to see how these physiological changes, like eye-blinks, heart rate variability, and skin conductance, are affected by the tasks, both with and without Deep Brain Stimulation. The study is currently unclear on its recruitment status and plans to enroll 80 people.","Physiological changes will be measured during the intervention\u002Fbehavioral tasks with and without stimulation.",136,"You will complete tasks on a computer, some using a virtual reality headset, while researchers measure your brain activity, heart rate, and skin perspiration.","Not stated in the trial record.",[33],"v2"]