Middle Meningeal Artery Embolization for Chronic Migraine

Middle Meningeal Artery Embolization for Treatment of Chronic Migraine: A Pilot Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Migraine
• Intervention / Treatment: Procedure: Middle Meningeal Artery Embolization

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Middle Meningeal Artery Embolization; Participants receive middle meningeal artery embolization	Procedure: Middle Meningeal Artery Embolization; Middle meningeal artery embolization using particles or coils

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine Disability Assessment (MIDAS)	The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.	Baseline
Migraine Disability Assessment (MIDAS)	The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.	1 Hour Post Procedure
Migraine Disability Assessment (MIDAS)	The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.	Day 15 Follow Up
Migraine Disability Assessment (MIDAS)	The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.	Month 3 Follow Up
Migraine Disability Assessment (MIDAS)	The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.	Month 6 Follow Up
Migraine Disability Assessment (MIDAS)	The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.	Month 12 Follow Up
Migraine Pain Scale	Migraine pain scale range is 1-10 with a higher indicating severe level of pain.	Baseline
Migraine Pain Scale	Migraine pain scale range is 1-10 with a higher indicating severe level of pain.	1 Hour Post Procedure
Migraine Pain Scale	Migraine pain scale range is 1-10 with a higher indicating severe level of pain.	Day 15 Follow Up
Migraine Pain Scale	Migraine pain scale range is 1-10 with a higher indicating severe level of pain.	Month 3 Follow Up
Migraine Pain Scale	Migraine pain scale range is 1-10 with a higher indicating severe level of pain.	Month 6 Follow Up
Migraine Pain Scale	Migraine pain scale range is 1-10 with a higher indicating severe level of pain.	Month 12 Follow Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Pain Meds Used Post Procedure	Number of pain meds used by participant post embolization procedure	1 Hour Post Procedure
Number of Pain Meds Used Post Procedure	Number of pain meds used by participant post embolization procedure	6 Hours Post Procedure
Number of Pain Meds Used Post Procedure	Number of migraine pain meds used by participant post embolization procedure	Day 15 Follow Up
Number of Pain Meds Used Post Procedure	Number of migraine pain meds used by participant post embolization procedure	Month 3 Follow Up
Number of Pain Meds Used Post Procedure	Number of migraine pain meds used by participant post embolization procedure	Month 6 Follow Up
Number of Pain Meds Used Post Procedure	Number of migraine pain meds used by participant post embolization procedure	Month 12 Follow Up

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Hamad Farhat, MD, Advocate Christ Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 1, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chronic migraine; drug-resistant migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: IRB00131621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No