[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04824105":3,"trial-entities:NCT04824105":110,"trial-summary:NCT04824105":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":42,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":85,"locations":88,"central_contacts":103,"overall_officials":107,"references":108,"see_also_links":109},"NCT04824105","00106843","Modulating Anxious Coping","Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum","RECRUITING","2026-12-30","2026-03","2026-03-17","2021-06-26","Medical University of South Carolina","OTHER",null,"This is a study to find out if a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how people with anxiety or related concerns cope with feared or anxiety-producing situations. The study is recruiting people who recently started treatment for anxiety or a related concern. The study involves 3 visits to the Medical University of South Carolina. At the first visit, participants do interviews and surveys asking about anxiety and related concerns, and they also do tasks where they see and react to emotional pictures while their brain activation is measured. At the next two visits, participants receive rTMS, which works by rapidly turning a focused magnetic field on and off repeatedly over the head in a way that passes directly through the hair, scalp, and skull and onto the brain and can temporarily increase brain activity under the magnetic field. After rTMS, participants do two tasks where they see and react to emotional situations while wearing sensors on their hand, arms, face, and head.\n\nEach visit in this study is expected to last between 2 - 4 hours. This is not a treatment study, but the study is being conducted with the hope that it will help improve treatment in the future.",[18],"Anxiety Disorders",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"NA",{"count":25,"type":26},80,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Repetitive Transcranial Magnetic Stimulation (rTMS)","A repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System will be used to deliver intermittent theta burst to ventromedial prefrontal cortex, and continuous theta burst to pre-supplementary motor area.",[33],"Neurostimulation Group",[35,39],{"measure":36,"description":37,"timeFrame":38},"Change in Fear-Potentiated Startle Reflex","Fear-potentiated startle is measured during an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. Fear-potentiated startle measures motivational activation during the preparation period.","Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)",{"measure":40,"description":41,"timeFrame":38},"Change in Speed to Initiate Avoidance Behavior","Reaction time to initiate flight is measured in an experimental task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. Reaction time measures behavioral tendency to approach or avoid.",[43,46,49,52,55,58,61],{"measure":44,"description":45,"timeFrame":38},"Change in Escape\u002F Avoidance Electroencephalography","Electroencephalography (EEG) is measured during an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. An event-related potential, the stimulus-preceding negativity, will be derived from the EEG to index action preparation processing.",{"measure":47,"description":48,"timeFrame":38},"Change in Approach\u002F Avoidance Conflict Electroencephalography","Electroencephalography (EEG) is measured during an experimental task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. A frequency signature, power in the theta frequency band, will be derived from the EEG to index cognitive control processes.",{"measure":50,"description":51,"timeFrame":38},"Change in Task-Related Heart Rate Changes","Heart rate is measured during experimental tasks in which: 1) participants prepare to avoid, escape, or simply be exposed to aversive pictures; 2) participants can win money but also must evade a slow, moderate, or fast virtual predator. Heart rate slowing measures task-related engagement of attention, while heart rate increase indicates defensive activation.",{"measure":53,"description":54,"timeFrame":38},"Change in Task-Related Skin Conductance Responding","Skin conductance is measured during experimental tasks in which: 1) participants prepare to avoid, escape, or simply be exposed to aversive pictures; 2) participants can win money but also must evade a slow, moderate, or fast virtual predator. Skin conductance increases indicate task-related sympathetic arousal.",{"measure":56,"description":57,"timeFrame":38},"Change in Task-Related Perceived Control","Perceived control over aversive stimuli is queried after an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. Perceived control for each condition is queried using self-report Likert-type scales for each condition.",{"measure":59,"description":60,"timeFrame":38},"Change in Difficulty of Avoiding Task-Based Aversive Exposure","Difficulty of avoiding exposure to aversive stimulation is queried after each trial during a task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. Avoidance difficulty is queried using a Likert-type scale delivered after each trial. The scale ranges from 1 to 5, with higher scores indicating greater perceived difficulty of avoiding capture by the virtual predator.",{"measure":62,"description":63,"timeFrame":38},"Change in State Anxiety During Session","State-level anxiety is measured throughout the experimental session using the State-Trait Anxiety Inventory - State Form. The State-Trait Anxiety Inventory - State Form uses 20 items querying anxiety symptom experience in the present moment to measure how anxiety fluctuates across the experimental session. The scale ranges from 20 to 80, with higher scores indicating higher state anxiety.","ALL","18 Years","65 Years",false,{"inclusion":69,"exclusion":75,"raw_text":84},[70,71,72,73,74],"18 - 65 y.o.","Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia), posttraumatic stress disorder, obsessive- compulsive disorder, or current adjustment disorder with anxiety","Is currently seeking mental health treatment","Is able to read consent document and provide informed consent.","English is a first or primary fluent language.",[76,77,78,79,80,81,82,83],"Current alcohol or substance use disorder of more than mild severity (as defined by DSM-5 and determined using standardized self-report instruments)","Lifetime diagnosis of psychotic disorder or bipolar mania","Presence of neurological disorder that contraindicates TMS or neurophysiological recording: Seizure disorder Lifetime history of traumatic brain injury with loss of consciousness Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)","Presence of other medical disorder that would make it too uncomfortable to sit or lie still for long recording periods","Presence of standard contraindications for MRI or rTMS Metal in the body Currently pregnant Claustrophobia Significant sensitivity to noise Medical conditions or treatments that lower seizure threshold History of severe brain injury History of seizures\u002F epilepsy","Currently taking anticholinergic mediation, neuroleptic medication, or sedative\u002F hypnotic medication Note: SSRI, cholinesterase inhibitors or NMDA receptor antagonists are allowed if patient has been on a stable regimen of four weeks prior to enrollment","Currently taking chronic opiate medications or substances","Currently taking naltrexone","Inclusion Criteria:\n\n* 18 - 65 y.o.\n* Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia), posttraumatic stress disorder, obsessive- compulsive disorder, or current adjustment disorder with anxiety\n* Is currently seeking mental health treatment\n* Is able to read consent document and provide informed consent.\n* English is a first or primary fluent language.\n\nExclusion Criteria:\n\n* Current alcohol or substance use disorder of more than mild severity (as defined by DSM-5 and determined using standardized self-report instruments)\n* Lifetime diagnosis of psychotic disorder or bipolar mania\n* Presence of neurological disorder that contraindicates TMS or neurophysiological recording: Seizure disorder Lifetime history of traumatic brain injury with loss of consciousness Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)\n* Presence of other medical disorder that would make it too uncomfortable to sit or lie still for long recording periods\n* Presence of standard contraindications for MRI or rTMS Metal in the body Currently pregnant Claustrophobia Significant sensitivity to noise Medical conditions or treatments that lower seizure threshold History of severe brain injury History of seizures\u002F epilepsy\n* Currently taking anticholinergic mediation, neuroleptic medication, or sedative\u002F hypnotic medication Note: SSRI, cholinesterase inhibitors or NMDA receptor antagonists are allowed if patient has been on a stable regimen of four weeks prior to enrollment\n* Currently taking chronic opiate medications or substances\n* Currently taking naltrexone",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":13,"status":8,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":100},"Charleston","South Carolina","29425","United States",[95],{"name":96,"role":97,"phone":98,"email":99},"Christopher T Sege","CONTACT","9787641480","sege@musc.edu",{"lat":101,"lon":102},32.77632,-79.93275,[104],{"name":105,"role":97,"phone":106,"email":99},"Christopher T Sege, PhD","8437928465",[],[],[],{"nct_id":4,"conditions":111,"biomarkers":116},[112,113,114,115],"Adjustment Disorder","Anxiety Disorder","Obsessive Compulsive Disorder","Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":118,"summary":119,"prompt_version":129},true,{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study with a planned enrollment of 80 participants. It is not specified if it is randomized or blinded.","completed","Modulating Anxious Coping with rTMS","This study is exploring if a device called repetitive Transcranial Magnetic Stimulation (rTMS) can change how people with anxiety cope with stressful situations. rTMS uses magnetic pulses to temporarily alter brain activity. Researchers will measure changes in your fear response (Fear-Potentiated Startle Reflex) and how quickly you avoid feared situations (Speed to Initiate Avoidance Behavior) immediately before and after receiving rTMS. The study is looking for 80 participants aged 18 to 65 who have an anxiety disorder (like Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia, PTSD, or OCD) and are currently seeking mental health treatment. The study's current recruitment status is unclear.","The primary endpoints are measured immediately before and immediately after stimulation, approximately 30 minutes apart.",105,"You would have 3 visits to the Medical University of South Carolina. The first visit includes interviews, surveys about anxiety, and tasks where your brain activation is measured while viewing emotional pictures.","Not stated in the trial record.",[30],"v2"]