Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine

Study Overview
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Brief Summary
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This study is a single-arm, self-controlled clinical trial that aims to explore and evaluate the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to record and evaluate the effectiveness and safety of the treatment.

Detailed Description
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This study is a single-arm, self-controlled clinical trial that aims to explore and evaluate the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The inclusion criteria consist of patients with or without aura migraines, who have experienced persistent, chronic migraines for at least 3 months prior to screening, and have shown resistance to at least two or more drug treatments, with unsatisfactory therapeutic effects, intolerable side effects, or contraindications. The main objectives of the study are to record and evaluate the effectiveness and safety of the treatment.The content that needs to be recorded includes Headache attack frequency (times / month and Headache duration),Headache attack frequency (days / month),Days of medication in acute phase and dosage,Severity of headache,Headache aura(nausea,photophobia,phonophobia) frequency,Migraine Disability Assessment,Headache Impact,Migraine-Specific Questionnaire,Hospital Anxiety and Depression Scale,Patient Clinical Global Impression.

Official Title
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Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine：a Single-arm, Self-control, Open-label, Multicenter Trial

Conditions
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Migraine

Intervention / Treatment
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* Procedure: Middle meningeal artery embolization


Participation Criteria
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Eligibility Criteria
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Inclusion criteria： Voluntary written informed consent. Age 18 80 years old (inclusive), regardless of gender. Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition Patients with intractable migraine or refractory headache with migraine duration of more than 3 months and recurring migraine in the past 90 days before screening. Patients who take two or more drugs are not satisfied with the therapeutic effect, the side effects of drug treatment are difficult to tolerate or have contraindications. Headache frequency should be confirmed within 30 days before screening. Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation. Exclusion criteria： Patients with cervical spondylosis and secondary headaches such as otogenic, nasal, and odontogenic patients with a history of trigeminal autonomic headache, other definite causes of headache, or secondary headache. Patients without suitable vascular access. Patients scheduled for surgery within 90 days. The life expectancy of patients is less than 12 months. History of contrast agent allergy. Lactating or pregnant women, or patients with a fertility plan within 1 year. The clinical status of the patient was extremely poor, with an mRS Score ≥4. Participants who had participated in clinical studies of other drugs or medical devices before enrollment and did not meet the primary study endpoint time limit. The investigator judged that the patient had poor compliance and could not complete the study as required. The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy. Patient was allergic to the contrast agent. Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study. Patients have clotting disorders or are on anticoagulant therapy. Patients have a history of opioid addiction. Researchers believe that patients who are not suitable to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Middle meningeal artery embolization<br>Middle meningeal artery embolization with coil. | Procedure: Middle meningeal artery embolization<br>* Middle meningeal artery embolization with coil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache attack frequency (times / month and Headache duration） | Record of headache attack frequency (times / month and Headache duration） | At baseline and 30 days,60 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache attack frequency (days / month) | Record of headache attack frequency (days / month) | At baseline, 30 days, and 60 days after treatment | 
| Days of medication in acute phase and dosage | Record of days of medication in acute phase and dosage | At baseline, 30 days, and 60 days after treatment | 
| Severity of headache | VAS/NRS pain rating scale | At baseline,36 hours,day of discharge,30 days,and 60 days after treatment | 
| Headache aura(nausea,photophobia,phonophobia) frequency | Record of headache aura | At baseline,30 days,and 60 days after treatment | 
| Migraine Disability Assessment | Migraine Disability Assessment (MIDAS) | At baseline,30 days,and 60 days after treatment | 
| Headache Impact | Headache Impact Test (HIT-6) | At baseline,30 days,and 60 days after treatment | 
| Migraine-Specific Questionnaire | Migraine-Specific Questionnaire（MSQ） | At baseline,30 days,and 60 days after treatment | 
| Hospital Anxiety and Depression Scale | Hospital Anxiety and Depression Scale(HADS) | At baseline,30 days,and 60 days after treatment | 
| Patient Clinical Global Impression | At baseline,30 days,and 60 days after treatment(PCGI) | Patient Clinical Global Impression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Middle meningeal artery, Ambolization, Coil