Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine.

Официальное название

Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine: A Multicenter, Prospective, Double-blind, Multigroup, Randomized Controlled Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Middle meningeal artery embolization
  Middle meningeal artery embolization with coils.
• Препарат Conventional standard pharmacotherapy for migraine
  Conventional standard pharmacotherapy for migraine

Первичные конечные точки

• Migraine attack frequency (days / month) [Срок оценки: :At baseline,within 90 days, 90-day, 180-day after treatment]

Вторичные конечные точки (9)

• Migraine attack frequency (times / month) [Срок оценки: At baseline, within 90 days, 90-day, 180-day after treatment]
• Total headache frequency (days / month) [Срок оценки: At baseline, within 90 days after treatment]
• Migraine medication use frequency (days / month) [Срок оценки: At baseline, within 90 days, 90-day, 180-day after treatment]
• Proportion of ≥50% reduction in migraine days (days/month) [Срок оценки: At baseline, within 90 days, 90-day, 180-day after treatment]
• Numerical Rating Scale for migraine pain severity (NRS) (score/month) [Срок оценки: At baseline, within 90 days, 180 days after treatment]
• Migraine Disability Assessment Questionnaire (MIDAS) (score/month) [Срок оценки: At baseline, within 90 days, 180 days after treatment]
• Clinical Global Impression Scale (CGI) (score/month) [Срок оценки: At baseline, within 90 days, 180 days after treatment]
• Headache Impact Test (HIT-6) (score/month) [Срок оценки: At baseline, within 90 days, 180 days after treatment]
• Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) (score/month) [Срок оценки: At baseline, within 90 days, 180 days after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Tempaku A, Yamauchi S, Ikeda H, Tsubota N, Furukawa H, Maeda D, Kondo K, Nishio A. Usefulness of interventional embolization of the middle meningeal artery for recurrent chronic subdural hematoma: Five cases and a review of the literature. Interv Neuroradiol. 2015 Jun;21(3):366-71. doi: 10.1177/1591019915583224. Epub 2015 May 26. PMID 26015518
• Levy D, Moskowitz MA. Meningeal Mechanisms and the Migraine Connection. Annu Rev Neurosci. 2023 Jul 10;46:39-58. doi: 10.1146/annurev-neuro-080422-105509. Epub 2023 Mar 13. PMID 36913712
• Lam A, Selvarajah D, Htike SS, Chan S, Lalloo S, Lock G, Redmond K, Leggett D, Mews P. The efficacy of postoperative middle meningeal artery embolization on chronic subdural hematoma - A multicentered randomized controlled trial. Surg Neurol Int. 2023 May 12;14:168. doi: 10.25259/SNI_208_2023. eCollection 2023. PMID 37292400
• Xu K, Cui J, Demiraj F, Chen G, Wang Q, Mokin M, Yan Z, Peng H, Huang Y, Peng Z, Xiang X, Chu L, Wu S, Song S, Zheng Y, Wang L, Cai J, Shao Y, Yao Y, Yang H, Ren Z. Middle meningeal artery embolization for migraine headaches - a prospective self-control cohort trial. Int J Surg. 2026 Feb 1;112(2):3399-3411. doi: 10.1097/JS9.0000000000003714. Epub 2025 Nov 4. PMID 41186515
• Catapano JS, Karahalios K, Srinivasan VM, Baranoski JF, Rutledge C, Cole TS, Ducruet AF, Albuquerque FC, Jadhav AP. Chronic headaches and middle meningeal artery embolization. J Neurointerv Surg. 2022 Mar;14(3):301-303. doi: 10.1136/neurintsurg-2021-017602. Epub 2021 Apr 22. PMID 33888570
• Valdueza JM, Dreier JP, Woitzik J, Dohmen C, Sakowitz O, Platz J, Leistner-Glaess S, Witt VD. Course of Preexisting Migraine Following Spontaneous Subarachnoid Hemorrhage. Front Neurol. 2022 Jul 11;13:880856. doi: 10.3389/fneur.2022.880856. eCollection 2022. PMID 35899261
• Fan Z, Fan Z, Wang H. New surgical approach for migraine. Otol Neurotol. 2006 Aug;27(5):713-5. doi: 10.1097/01.mao.0000226304.66822.6d. PMID 16868520
• Mancuso-Marcello M, Qureshi AI, Nikola C, Stoian I, Jia Y, Saeed D, Bhogal P. Intra-arterial lidocaine therapy via the middle meningeal artery for migraine headache: Theory, current practice and future directions. Interv Neuroradiol. 2026 Feb;32(1):104-108. doi: 10.1177/15910199231195470. Epub 2023 Aug 13. PMID 37574789

Идентификаторы

NCT: NCT07633067 · FAST-EM-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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