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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Headache Frequency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Migraine Patients Undergoing MMA Embolization
Adults aged 18 to 64 years with a diagnosis of migraine who have undergone or plan to undergo middle meningeal artery (MMA) embolization as part of routine clinical care. Participants are enrolled in an observational registry that accesses and analyzes clinical and patient-reported outcome data already documented through routine care. Study participation does not influence clinical management, procedural technique, device selection, or follow-up.
干预措施: Middle Meningeal Artery Embolization (Procedure)
结局指标
主要结局
Change in Patient-Reported Headache Frequency
时间窗: Baseline and 12 Months
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.
次要结局
- Change in HIT-6 Score(Baseline and 12 Months)