[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627912":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Children's Mercy Hospital Kansas City","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immersive Neurofeedback Self-Regulation Training (INSeRT)","EXPERIMENTAL","Participants receive a home-based immersive virtual reality intervention that integrates real-time EEG signals from a wearable headband to provide neurofeedback during virtual reality sessions. Sessions are completed three times per week for approximately 8 minutes per session over 4 weeks.",[13],"Behavioral: Immersive Neurofeedback Self-Regulation Training (INSeRT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Virtual Reality Imagery (No Neurofeedback)","ACTIVE_COMPARATOR","Participants receive a home-based immersive virtual reality imagery experience without neurofeedback and without guided relaxation training. Sessions are completed three times per week for approximately 8 minutes per session over 4 weeks.",[19],"Behavioral: Virtual Reality Imagery (No Neurofeedback)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","A home-based behavioral intervention that integrates real-time EEG signals from a wearable headband into a virtual reality environment to provide neurofeedback during brief self-regulation training sessions. Participants complete sessions three times per week for approximately 8 minutes per session over 4 weeks.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"A home-based virtual reality imagery experience delivered without neurofeedback or guided relaxation training. Participants complete sessions three times per week for approximately 8 minutes per session over 4 weeks.",[15],[30],{"name":31,"affiliation":32,"role":33},"Mark A Connelly, PhD","Children's Mercy","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","816-234-3193","mconnelly1@cmh.edu",[40],{"facility":32,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Kansas City","Missouri","64108","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-94.57857,39.09973,{"lat":51,"lon":50},[54,58],{"name":55,"role":36,"phone":56,"phoneExt":25,"email":57},"Priscilla Connell, PhD","816-816-6979","pconnell@cmh.edu",{"name":59,"role":36,"phone":37,"phoneExt":25,"email":38},"Mark Connelly, PhD",{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mark Connelly","Professor of Pediatrics",[64],{"name":65,"class":66},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100627912","a-feasibility-trial-of-virtual-reality-neurofeedback-for-adolescents-with-migraine-100627912",false,"NCT07454798","A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine","Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine","INSeRT","Inclusion Criteria:\n\n* Age 10-16 years (inclusive)\n* Diagnosis of migraine (with or without aura, or chronic migraine) by a qualified headache specialist\n* At least 4 migraine headaches per month\n* Presence of headache-free periods between migraine episodes\n\nExclusion Criteria:\n\n* Significant physical, psychiatric, or developmental conditions that would limit ability to participate in study procedures\n* Clinically elevated Pediatric Vestibular Symptoms Questionnaire (PVSQ) score (\\>0.68) or new\u002Fworsening vestibular symptoms prior to randomization\n* Initiation of a new migraine preventive medication within 4 weeks prior to randomization\n* Current participation in behavioral treatment for migraine (e.g., cognitive behavioral therapy or biofeedback)\n* History of epilepsy or photosensitive seizures","ALL","10 Years","16 Years",{"count":79,"type":80},38,"ESTIMATED","INTERVENTIONAL",[83],"NA","The goal of this clinical trial is to learn whether a home-based virtual reality (VR) neurofeedback program is feasible and acceptable for adolescents with migraine. The study will also explore whether the program may improve headache-related outcomes.\n\nThe main questions it aims to answer are:\n\nIs it feasible to enroll, randomize, and retain adolescents with migraine in this study?\n\nDo participants complete the VR sessions and study procedures as intended?\n\nAre there preliminary signals that the VR neurofeedback program may improve headache-related disability and symptoms?\n\nResearchers will compare Immersive Neurofeedback Self-Regulation Training (INSeRT), which uses brain activity recorded from a wearable electroencephalogram (EEG) headband to guide the VR experience, to a comparison VR program that presents immersive imagery without neurofeedback or guided relaxation training.\n\nParticipants will:\n\nComplete a 4-week baseline period that includes headache logs, questionnaires, and a laboratory EEG assessment\n\nBe randomly assigned to one of two VR programs\n\nComplete VR sessions at home three times per week for 4 weeks\n\nComplete questionnaires at the end of treatment and again approximately 3 months later\n\nRepeat the laboratory EEG assessment at the end of treatment",[86,87],"Migraine","Headache Disorders, Primary",[89,90,91,92,93,94,95,96,97,98],"Pediatric migraine","Adolescents","Neurofeedback","Virtual reality","Electroencephalogram","EEG","Cortical excitability","Self-regulation","Biofeedback","Mind-body therapy","2026-06-01",{"date":101,"type":102},"2026-06-03","ACTUAL",{"date":104,"type":102},"2026-05-13",{"date":106,"type":80},"2028-05-31",{"name":5,"class":6},1]