Middle Meningeal Artery Embolization for Chronic Migraine

Wake Forest University (WFU)

Status: Not yet enrolling

Conditions: Migraine

Treatments: Procedure: Middle Meningeal Artery Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT07044648

IRB00131621

Details and patient eligibility

About

The main goal of this study is to find out how well middle meningeal artery coil embolization works for patients with recurrent chronic migraines that are not resolved with medication.

Full description

This study seeks to evaluate the therapeutic potential of middle meningeal artery coil embolization as an interventional strategy for patients with recurrent and pharmacoresistant chronic migraine. Middle meningeal artery embolization has recently gained recognition as a safe and effective intervention for the management of chronic subdural hematoma, demonstrating a low complication profile. The procedure achieves therapeutic effect by reducing or occluding arterial flow within the middle meningeal artery, thereby minimizing arterial dilatation and facilitating hematoma resorption over time.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with diagnosis of migraine with or without aura, chronic migraine, unilateral or bilateral, moderate to severe intensity, 4-72 hours, familiar or sporadic, status migrainosus, primary or secondary
• Patient who failed pharmacologic treatment (at least 2 failed drugs treatment for more than 3 months) or have considerable side effects
• Patient with diagnosis of migraine and preference for embolization treatment
• Clinical follow up of at least 3 months
• Baseline computed tomography head (CTH) or MR brain which rule out additional intracranial pathology (patient with baseline intracranial pathology other than migraine will be excluded; see the exclusion criteria section below)
• Presence of patent middle meningeal artery homolateral to the side of migraine

Exclusion criteria

• Previous middle meningeal artery embolization for subdural hematoma
• Previous craniotomy
• Patients aged 17 years or younger.
• Incomplete embolization of middle meningeal artery
• Patient with baseline CTH or MR brain showing baseline intracranial pathology that can explain migraine

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Middle Meningeal Artery Embolization

Experimental group

Description:

Participants receive middle meningeal artery embolization

Treatment:

Procedure: Middle Meningeal Artery Embolization