EMBRACE-OBS: Single-Site Observational Registry of Patient-Reported Outcomes Following MMA Embolization for Migraine
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Middle Meningeal Artery Embolization.
- Кому может быть актуально
- Состояния в реестре: Migraine Disorders, Chronic Migraine Headache, Migraine. Базовые параметры: 18 лет — 64 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
EMBRACE-OBS is the first phase of the EMBRACE research program and is conducted as a single-site observational registry at Cortex Neurovascular.
Migraine 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.
The 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.
The 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.
Secondary 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.
Patient 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.
EMBRACE-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.
Вмешательства
- Процедура Middle Meningeal Artery Embolization
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.
Первичные конечные точки
- Change in Patient-Reported Headache Frequency [Срок оценки: Baseline and 12 Months]
Вторичные конечные точки (1)
- Change in HIT-6 Score [Срок оценки: Baseline and 12 Months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Cortex Neurovascular / TRA Union — Tacoma
Идентификаторы
NCT: NCT07652034 · EMBRACE-OBS