Enduring Migraine Benefit From Responsive Artery Coil Embolization (EMBRACE): A Single-Site, Non-Significant Risk Pilot Study of Middle Meningeal Artery Embolization Using FDA-Cleared Coils for Refractory Episodic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Monthly Headache Days Post-Embolization
研究概览
简要总结
This single-site, open-label pilot study evaluates the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy targeting meningeal arterial contributors to migraine. Adults aged 18-60 with refractory migraine despite prior preventive therapies are eligible. The study assesses migraine outcomes over 12 months using patient-reported headache frequency, pain intensity, acute medication use, migraine-related disability (MIDAS), and quality-of-life measures (MSQ v2.1).
详细描述
This is an investigator-initiated, prospective, single-site, open-label pilot study designed to evaluate the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment approach targeting meningeal arterial contributors to migraine symptoms. TEMMA represents a structured clinical program applying endovascular treatment principles to patients with refractory migraine.
Participants undergo a baseline assessment period that includes prospective headache diary collection, capturing headache presence, pain intensity, and acute medication use, along with baseline migraine-related disability and quality-of-life assessments. Endovascular treatment is performed as part of the TEMMA program using FDA-cleared devices in accordance with institutional clinical practice. Procedural techniques, vessel selection, materials, adjunctive assessments, and treatment sequencing are determined by the treating physician and are not fully standardized within this pilot study.
Adjunctive assessments, which may include intra-procedural physiologic or pharmacologic evaluations, may be performed at the discretion of the treating physician to inform clinical decision-making but are not required for study participation and are not used as mandatory eligibility criteria.
Participants are followed longitudinally with serial headache diary data and standardized patient-reported outcome measures collected at predefined intervals through 12 months following treatment. The primary endpoint is change in monthly headache days compared with baseline. Secondary endpoints include changes in headache intensity, acute medication use, migraine-related disability, quality of life, and durability of symptom improvement.
Safety is monitored throughout the study through adverse event reporting with independent physician oversight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Diagnosis of migraine (with or without aura)
- •≥8 headache days per month
- •Failure of ≥2 preventive medication classes
- •Ability to complete electronic headache diary and surveys
- •Ability to provide informed consent
排除标准
- •Secondary headache disorders
- •Prior MMA embolization
- •Contraindication to angiography or embolization
- •Pregnancy
- •Inability to comply with follow-up
研究组 & 干预措施
TEMMA Procedure (Targeted Embolization for Migraine Management)
Participants with refractory migraine undergo the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy addressing meningeal arterial contributors to migraine. Treatment is performed using FDA-cleared devices per institutional clinical practice. Procedural details and adjunctive assessments are individualized and not dictated by the study protocol. Outcomes are evaluated using within-subject comparison to baseline.
干预措施: TEMMA Endovascular Treatment (Device)
结局指标
主要结局
Change in Monthly Headache Days Post-Embolization
时间窗: Baseline to 12 months post-embolization
Change from baseline in the number of headache days per month following bilateral middle meningeal artery coil embolization, assessed via SMS-based headache diary.
次要结局
- Change in Acute Medication Use(Baseline to 12 months post-embolization.)
- Change in Headache Intensity(Baseline to 12 months post-embolization)
- Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score(Baseline to 3 months (assessed at 1, 3, 6, and 12 months).)
- Time to Symptom Recurrence Following Lidocaine Testing(Up to 4 weeks post-lidocaine testing.)
- Change in Migraine Disability Assessment (MIDAS) Score(Baseline to 3 months (assessed at 1, 3, 6, and 12 months).)
- Time to Symptom Recurrence Following Embolization(Up to 12 months post-embolization.)