Migraine
Conditions
Interventions
Single unit:middle meningeal artery embolization
Sponsors
Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent; 2. Aged 18-80 years (inclusive), regardless of gender; 3. Migraine was diagnosed by clinicians, according to the International Classification of Headache Disorders, 3rd Edition; 4. 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; 5. 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; 6. Headache frequency should be confirmed within 30 days before screening; 7. Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation.
Exclusion criteria
Exclusion criteria: 1. Patients with cervical spondylosis and secondary headache such as otogenic, nasal, and odontogenic patients with a history of trigeminal autonomic headache,other definite causes of headache or secondary headache; 2. Patients without suitable vascular access; 3. Patients scheduled for surgery within 90 days; 4. The life expectancy of patients is less than 12 months; 5. History of contrast agent allergy; 6. Lactating or pregnant women, or patients with a fertility plan within 1 year; 7. The clinical status of the patient was extremely poor, with an mRS Score >= 4; 8. 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; 9. The investigator judged that the patient had poor compliance and could not complete the study as required; 10. The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy; 11. Patient was allergic to the contrast agent; 12. Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study; 13. Patients have clotting disorders or are on anticoagulant therapy; 14. Patients have a history of opioid addiction; 15. Researchers believe that patients who are not suitable to participate in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Headache attack frequency (days/month); | — |
Secondary
| Measure | Time frame |
|---|---|
| Headache attack frequency (times / month and Headache duration);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;Clinical Global Impression; | — |
Countries
China
Contacts
Public ContactRen Zeguang
Affiliated Hospital of Guizhou Medical University
Outcome results
None listed