[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06854991":3,"trial-entities:NCT06854991":86,"trial-summary:NCT06854991":90},{"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":17,"conditions":18,"keywords":23,"study_type":27,"primary_purpose":14,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":47,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":68,"locations":70,"central_contacts":79,"overall_officials":80,"references":84,"see_also_links":85},"NCT06854991","STUDY00004727","Healthy Children and Virtual Reality Mediation of Simulated Pain","Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Anxiety and Pain Management","ENROLLING_BY_INVITATION","2026-12-31","2026-03","2026-03-17","2025-08-04","Nationwide Children's Hospital","OTHER",false,"The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and\u002For monitoring response to virtual reality (VR)-based pain reduction approaches for pain management in clinical trials.\n\n20 healthy children will be recruited for a 1-hour research visit where they will wear a blood pressure cuff to simulate pain and an fNIRS neuroimaging device while playing an immersive\u002Fengaging VR game, a passive VR video, and an iPad game.","The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and\u002For monitoring response to VR-based pain reduction approaches for pain management in clinical trials.\n\nCollaboration will occur through a team science model to address the following three specific aims:\n\nAim 1: To quantify the central nervous system (CNS) responses associated with self-reported pain intensity during a simulated pain condition.\n\nAim 2: To assess brain response patterns to virtual reality (VR)-based interventions for pain management.\n\nAim 3: To assess the degree to which objective brain measures and brain responses to VR intervention modulate objective brain markers of pain.",[19,20,21,22],"Acute Pain","Experimental Pain in Healthy Human Participants","Children","Adolescents",[19,24,25,26],"Experimental Pain","Virtual Reality","fNIRS","INTERVENTIONAL",[29],"NA",{"count":31,"type":32},20,"ESTIMATED",[34,38,42],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Active VR-PAT","Virtual Reality Pain Alleviation Tool (VR-PAT) hosted on a Pico Neo 3 Pro Eye headset. Both engagement and immersion.",[35],{"type":14,"name":39,"description":40,"armGroupLabels":41},"Passive VR-PAT","VR-PAT hosted on a Pico Neo 3 Pro Eye headset, with the active game participation removed. Immersion with engagement removed.",[39],{"type":14,"name":43,"description":44,"armGroupLabels":45},"iPad","VR-PAT hosted on an Apple iPad. Engagement with immersion removed.",[46],"iPad game",[48],{"measure":49,"description":50,"timeFrame":51},"Difference in brain activation picked up on fNIRS between the active VR, passive VR, iPad game, and control conditions","Mean within subject fNIRS signals of brain activation","Assessed continuously throughout the simulated pain session (60 minutes) for one visit",[],"ALL","6 Years","17 Years",true,{"inclusion":58,"exclusion":61,"raw_text":67},[59,60],"Age 6-17 years, inclusive","Subjects and legal guardians can communicate (read and write) using English",[62,63,64,65,66],"Currently experiencing any pain (acute or chronic)","Took any pain medication within the past 12 hours","Vision, hearing, or cognitive\u002Fmotor impairments preventing valid administration of study measures","History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras","Minors in foster care, incarcerated, or currently pregnant","Inclusion Criteria:\n\n* Age 6-17 years, inclusive\n* Subjects and legal guardians can communicate (read and write) using English\n\nExclusion Criteria:\n\n* Currently experiencing any pain (acute or chronic)\n* Took any pain medication within the past 12 hours\n* Vision, hearing, or cognitive\u002Fmotor impairments preventing valid administration of study measures\n* History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras\n* Minors in foster care, incarcerated, or currently pregnant",[69],"CHILD",[71],{"facility":13,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Columbus","Ohio","43205","United States",{"lat":77,"lon":78},39.96118,-82.99879,[],[81],{"name":82,"affiliation":13,"role":83},"Henry Xiang, MD, MPH, PhD, MBA","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[24,88],"Healthy Volunteers",[],{"nct_id":4,"found":15,"summary":91,"prompt_version":91},null]