Middle Meningeal Artery Embolization for Migraine
(EMBRACE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called middle meningeal artery coil embolization, a minimally invasive procedure, to help people with difficult-to-treat migraines. The study examines the safety and effectiveness of this treatment in reducing headache days and improving quality of life. Eligible participants should experience migraines causing at least eight headache days per month and have not improved with at least two different preventive medications. Participants will first undergo a test treatment to assess potential benefits from the full procedure. If successful, they will receive the actual treatment and be monitored for changes over a year. As an unphased trial, this study offers a unique opportunity to explore a novel treatment option for migraines.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators.
What prior data suggests that this embolization technique is safe for treating migraines?
Research has shown that middle meningeal artery embolization (MMAE) is generally safe for treating migraines. Studies have found that this procedure is minimally invasive and usually well-tolerated by most patients. In one study, eight out of nine patients (89%) reported significant improvement in their headache symptoms, indicating the treatment's effectiveness and safety.
While some side effects may occur, they are typically mild and rare. The coils used in this procedure have already received FDA approval for similar treatments, supporting their safety. Overall, MMAE appears to be a promising option for individuals with severe migraines who haven't found relief with other medications.12345Why are researchers excited about this trial?
Most treatments for migraines involve medications like triptans, beta-blockers, or anti-seizure drugs that aim to reduce symptoms and frequency. However, the Middle Meningeal Artery Coil Embolization offers something different. This innovative approach targets the blood vessels directly by blocking the middle meningeal artery using detachable coils. Researchers are excited because this method could potentially provide relief for those with migraines that don't respond well to traditional medications, offering a targeted, potentially long-lasting solution by addressing the root cause rather than just the symptoms.
What evidence suggests that middle meningeal artery coil embolization is effective for refractory migraine?
Research has shown that middle meningeal artery embolization (MMAE) might be a promising option for people whose migraines don't improve with regular medications. In this trial, participants will undergo bilateral middle meningeal artery coil embolization if they respond positively to lidocaine testing. One study reported that 89% of patients experienced a significant decrease in the frequency and severity of their headaches after the procedure. Another study found that all patients had major improvements in migraine frequency, intensity, and impact on daily activities. These results suggest that MMAE could help reduce both the number and severity of migraine attacks, making daily life easier for those affected.12346
Who Is on the Research Team?
Dennis Wang, MD
Principal Investigator
Cortex Neurovascular
Are You a Good Fit for This Trial?
The EMBRACE trial is for adults aged 18-60 who suffer from severe migraines at least 8 days a month and haven't found relief with two or more preventive medications. Participants must show a positive response to lidocaine testing to proceed with the main part of the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lidocaine Testing
Participants undergo bilateral MMA lidocaine testing via diagnostic cerebral angiography to assess short-term response
Post-Lidocaine Observation
Participants continue headache diary and assessments to monitor response to lidocaine testing
Treatment
Participants undergo bilateral MMA coil embolization using FDA-cleared detachable coils
Follow-up
Participants are monitored for safety and effectiveness after embolization with regular assessments
What Are the Treatments Tested in This Trial?
Interventions
- Middle Meningeal Artery Coil Embolization
Trial Overview
This study tests if blocking blood flow in arteries linked to migraine pain using coil embolization can reduce headache frequency and intensity. It's an open-label pilot, meaning everyone knows what treatment they're getting, and it tracks results over a year.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with refractory migraine who demonstrate a positive response (≥50% reduction in headache intensity or frequency) to bilateral middle meningeal artery lidocaine testing proceed to bilateral middle meningeal artery coil embolization using FDA-cleared detachable coils. Outcomes are assessed via within-subject comparison to baseline.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cortex Neurovascular
Lead Sponsor
Citations
Middle meningeal artery embolization for migraine: A review
This review of the literature aims to provide an in-depth analysis of the current state of knowledge regarding the effectiveness, safety, and ...
2.
journals.lww.com
journals.lww.com/international-journal-of-surgery/abstract/9900/middle_meningeal_artery_embolization_for_migraine.3546.aspxMiddle meningeal artery embolization for migraine...
Conclusions: MMAE for the treatment of refractory migraines appears to be a safe and potentially effective treatment modality. Given the small ...
EMBRACE: Middle Meningeal Artery Embolization for ...
Participants with refractory migraine who demonstrate a positive response (≥50% reduction in headache intensity or frequency) to bilateral ...
4.
evtoday.com
evtoday.com/articles/2025-june/middle-meningeal-artery-embolization-in-the-treatment-of-chronic-headachesMiddle Meningeal Artery Embolization in the Treatment of ...
After MMAE, with a mean follow-up of 489 ± 173 days, eight of the nine (89%) patients reported significant improvement in headache frequency and intensity, and ...
Middle Meningeal Artery Embolization for Intractable Migraines
Results: All three patients experienced significant improvements in migraine frequency, intensity, and associated disability. HDI and HIT-6 ...
Middle meningeal artery embolization in migraine
The study reported promising outcomes, with 89% of patients experiencing improved headaches and 78% achieving complete resolution. Similarly, a ...
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