[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07652034":3,"trial-entities:NCT07652034":96,"trial-summary:NCT07652034":99},{"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":22,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":33,"interventions":36,"primary_outcomes":42,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":68,"locations":70,"central_contacts":90,"overall_officials":93,"references":94,"see_also_links":95},"NCT07652034","EMBRACE-OBS","EMBRACE-OBS: Single-Site Observational Registry of Patient-Reported Outcomes Following MMA Embolization for Migraine","Enduring Migraine Benefit From Responsive Artery Coil Embolization - Observational (EMBRACE-OBS): A Single-Site Registry of Patient-Reported Outcomes Following Routine Clinical Care for Migraine","NOT_YET_RECRUITING","2028-06-01","2026-06","2026-06-18","2026-07-01","Cortex Neurovascular","INDUSTRY",false,"EMBRACE-OBS is the first phase of the EMBRACE research program. This single-site observational registry accesses and analyzes patient-reported outcome data already collected through routine clinical care from adults with migraine who have undergone or plan to undergo middle meningeal artery (MMA) embolization. The study describes changes in headache frequency, headache severity, medication use, migraine-related disability, quality of life, and reported adverse events over time without influencing clinical care.","EMBRACE-OBS is the first phase of the EMBRACE research program and is conducted as a single-site observational registry at Cortex Neurovascular.\n\nMigraine is a prevalent neurological disorder that can significantly affect quality of life and daily functioning. Middle meningeal artery (MMA) embolization is performed using FDA-cleared embolic devices. When used for migraine, the procedure is performed at the discretion of the treating physician as part of routine clinical care and independent of research participation.\n\nThe purpose of this registry is to access and analyze clinical and patient-reported outcome data already collected through routine clinical care in patients who have undergone or plan to undergo MMA embolization for migraine. The study does not influence clinical decision-making, procedural technique, device selection, or follow-up care.\n\nThe primary objective is to describe changes in patient-reported headache frequency and severity over time following MMA embolization performed as part of routine clinical care.\n\nSecondary objectives include describing changes in acute headache medication use, migraine-related disability, quality-of-life measures, medication use patterns, temporal patterns of symptom change, and the real-world safety profile of the procedure as reflected by reported adverse events and complications.\n\nPatient follow-up occurs through routine clinical care. Data accessed for this registry may include headache diaries, HIT-6 scores, clinical information, procedural information, medication use, and outcomes documented during routine clinical follow-up visits. No study-mandated interventions, procedures, visits, or assessments are performed. The research activity consists solely of accessing and analyzing information already documented during routine care.\n\nEMBRACE-OBS is conducted under a separate IRB-approved protocol (Solutions IRB Study 2026-Jun-1013). A separate interventional phase of the EMBRACE research program (EMBRACE-Full; NCT07313800) may be conducted in the future under appropriate regulatory approvals.",[19,20,21],"Migraine Disorders","Chronic Migraine Headache","Migraine",[23,24,21,25,26,27,28,29,5],"Middle Meningeal Artery Embolization","MMA Embolization","Headache","Patient-Reported Outcomes","HIT-6","Observational Registry","Neurointervention","OBSERVATIONAL",null,[],{"count":34,"type":35},50,"ESTIMATED",[37],{"type":38,"name":23,"description":39,"armGroupLabels":40},"PROCEDURE","Middle meningeal artery (MMA) embolization performed as part of routine clinical care at the discretion of the treating physician. The procedure is independent of study participation and is not assigned by the study protocol. The research activity consists solely of accessing and analyzing data already documented through routine clinical care.",[41],"Migraine Patients Undergoing MMA Embolization",[43],{"measure":44,"description":45,"timeFrame":46},"Change in Patient-Reported Headache Frequency","Change in patient-reported headache frequency, measured as headache days per month, from baseline to 12 months following middle meningeal artery (MMA) embolization performed as part of routine clinical care.","Baseline and 12 Months",[48],{"measure":49,"description":50,"timeFrame":46},"Change in HIT-6 Score","Change in migraine-related disability as assessed by the Headache Impact Test (HIT-6) score (range: 36-78; higher scores indicate greater headache impact\u002Fworse outcome) documented during routine clinical care.","ALL","18 Years","64 Years",{"inclusion":55,"exclusion":61,"raw_text":67},[56,57,58,59,60],"Adults aged 18 to 64 years","Diagnosis of migraine","Have undergone or plan to undergo middle meningeal artery (MMA) embolization as part of routine clinical care, independent of study participation","Able and willing to provide informed consent","Able to read and understand English sufficiently to complete informed consent and patient-reported outcome assessments",[62,63,64,65,66],"Age under 18 years","Pregnancy at the time of enrollment","Inability to provide informed consent","Inability to read and understand English sufficiently to complete informed consent and patient-reported outcome assessments","Insufficient clinical or patient-reported outcome data for the planned analyses","Inclusion Criteria:\n\n* Adults aged 18 to 64 years\n* Diagnosis of migraine\n* Have undergone or plan to undergo middle meningeal artery (MMA) embolization as part of routine clinical care, independent of study participation\n* Able and willing to provide informed consent\n* Able to read and understand English sufficiently to complete informed consent and patient-reported outcome assessments\n\nExclusion Criteria:\n\n* Age under 18 years\n* Pregnancy at the time of enrollment\n* Inability to provide informed consent\n* Inability to read and understand English sufficiently to complete informed consent and patient-reported outcome assessments\n* Insufficient clinical or patient-reported outcome data for the planned analyses",[69],"ADULT",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":87},"Cortex Neurovascular \u002F TRA Union","Tacoma","Washington","98405","United States",[78,83,84],{"name":79,"role":80,"phone":81,"email":82},"Dennis Wang, MD","CONTACT","253-284-0841","dwang@cortexmgmt.com",{"role":80,"email":82},{"name":85,"role":86},"Dennis O Wang, MD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},47.25288,-122.44429,[91],{"name":92,"role":80,"phone":81,"email":82},"Dennis Wang, Principal Investigator, MD",[],[],[],{"nct_id":4,"conditions":97,"biomarkers":98},[21],[],{"nct_id":4,"found":100,"summary":101,"prompt_version":111},true,{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an observational study with 50 planned participants. It is not a randomized or blinded study.","completed","Observational Study of MMA Embolization for Migraine","This study, EMBRACE-OBS, is looking at how Middle Meningeal Artery (MMA) embolization affects people with migraine. MMA embolization is a procedure already used in routine care for migraine. This study will collect information that doctors already gather from patients, like how often they get headaches, how severe they are, and how their quality of life changes after the procedure. It aims to understand if MMA embolization helps reduce headache frequency over time. You could join if you are an adult aged 18-64 with a migraine diagnosis who has had or plans to have MMA embolization as part of your regular medical care. The study will look for changes in your headache frequency at the start and again 12 months later. This is an observational study, meaning it won't change your medical care; it just collects information.","Participants' headache frequency will be measured at the start of the study and again 12 months later.",136,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]