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This study is a single-arm, self-controlled clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.
This study is a single-arm, self-controlled, open-label, single-center clinical trial that explores and evaluates 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 before 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 evaluate the effectiveness and safety of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle meningeal artery embolization | Experimental | Middle meningeal artery embolization with coil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Middle meningeal artery embolization | Procedure | Middle meningeal artery embolization with coil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache attack frequency (times / month and Headache duration) | Record of headache attack frequency (times / month and Headache duration) | At baseline, 90 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Headache attack frequency (days / month) | Record of headache attack frequency (days / month) | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Days of medication in acute phase and dosage |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeguang Ren, MD. PhD. | The Affiliated Hospital Of Guizhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550001 | China |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Self-control
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Record of days of medication in acute phase and dosage
| At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Severity of headache:Visual Analogue Scale | The scale is mainly composed of a 10cm straight line, one end represents 0 (no pain at al), and the other end represents 10(the worst pain) | At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Severity of headache:Numerical Rating Scale | The headache level is rated from 0 (no pain) to 10 (the most severe) | At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Headache aura(nausea,photophobia,phonophobia) frequency | Record of headache aura | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Migraine Disability Assessment | The Migraine Disability Assessment questionnaire (MIDAS) | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Headache Impact | Headache Impact Test (HIT-6) | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Migraine-Specific Questionnaire | Migraine-Specific Questionnaire(MSQ) | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Hospital Anxiety and Depression | Hospital Anxiety and Depression Scale(HADS) | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| Clinical Global Impression | Clinical Global Impression(CGI) | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment |
| D009422 | Nervous System Diseases |