Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine: A Multicenter, Prospective, Double-blind, Multigroup, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
研究概览
简要总结
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.
详细描述
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.This study will enroll 150 subjects with a long history of headache from multiple clinical centers, who will be randomly assigned using a stratified randomization method via computer and web-based software. Stratified randomization will be performed according to study centers (different sub-centers). Subjects will be randomly allocated in a 1:1:1 ratio to the unilateral embolization group, bilateral embolization group, or conventional pharmacotherapy group (hereinafter referred to as the "control group"), with 50 subjects in each group. The unilateral embolization group will receive unilateral MMA interventional embolization plus conventional pharmacotherapy, the bilateral embolization group will receive bilateral MMA interventional embolization plus conventional pharmacotherapy, and the control group will receive only conventional standard pharmacotherapy. Baseline data prior to randomization and data on primary and secondary endpoint scores will be collected for all enrolled subjects. Regular follow-up will be conducted to evaluate the recovery of headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~80 years old (inclusive), regardless of gender.
- •Voluntary written informed consent.
- •Migraine diagnosed by neurologists/pain specialists according to the current International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria for migraine with or without aura.
- •Migraine attack frequency of no less than 4 days per month within one month prior to enrollment.
- •History of pharmacotherapy for migraine prophylaxis or treatment for at least 6 months.
排除标准
- •Findings on cerebral angiography indicating secondary headache due to intracranial vascular disorders, including dural arteriovenous fistula, arteriovenous malformation, venous malformation, or other relevant cerebrovascular lesions; Moyamoya disease; or high-risk vascular anatomical variants unsuitable for safe vascular access or contraindicating MMA embolization.
- •Complicated with cervical spondylosis and secondary headache of otogenic, rhinogenic, odontogenic origin; patients with a history of trigeminal autonomic cephalalgias; headache with other definite etiologies or secondary headache;
- •Imaging diagnosis shows acute or chronic subdural hematoma, other acute intracranial lesions and other space-occupying lesions;
- •Patients planning to undergo surgery within 90 days;
- •Patients with a life expectancy of less than 12 months;
- •Patients with a definite history of contrast media allergy;
- •Patients with a history of opioid addiction;
- •Breastfeeding or pregnant women, or patients with fertility plans within half a year;
- •Subjects who participated in other clinical trials of drugs or medical devices before enrollment and did not reach the time limit of the primary study endpoint;
- •Unable to understand headache-related assessment data such as headache diaries and requiring assistance from others to complete them;
- •Patients with poor compliance judged by the investigator and unable to complete the study as required;
- •Patients with a definite history of allergy to embolization materials such as nitinol alloy and/or cobalt-based alloy, platinum-tungsten alloy, etc.;
- •Subjects with other comorbidities that restrict their participation in the study, prevent compliance with follow-up, or affect the scientific integrity of the study;
- •Other conditions in which the investigator considers the patient inappropriate to participate in this study.
研究者
Zeguang Ren
Professor, principle investigator, Department of Neurosurgery
The Affiliated Hospital Of Guizhou Medical University