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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Middle meningeal artery embolization with coil.
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Headache attack frequency (times / month and Headache duration)
Record of headache attack frequency (times / month and Headache duration)
Time frame: At baseline, 90 days after treatment
Headache attack frequency (days / month)
Record of headache attack frequency (days / month)
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Days of medication in acute phase and dosage
Record of days of medication in acute phase and dosage
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine Disability Assessment
The Migraine Disability Assessment questionnaire (MIDAS)
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Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache Impact
Headache Impact Test (HIT-6)
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine-Specific Questionnaire
Migraine-Specific Questionnaire(MSQ)
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Hospital Anxiety and Depression
Hospital Anxiety and Depression Scale(HADS)
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Clinical Global Impression
Clinical Global Impression(CGI)
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment