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

ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Affiliated Hospital Of Guizhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Middle meningeal artery embolization
  • Conventional standard pharmacotherapy for migraine

Treatment groups

150 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

The Affiliated Hospital Of Guizhou Medical University

Lead sponsor

Sichuan Action Medical Technology Co., Ltd.

Collaborator

Juhui Medical Technology (Shenzhen) Co., Ltd.

Collaborator

Beijing Xinke Medical Technology Co., Ltd.

Collaborator