Migraine
Conditions
Keywords
Migraine, Middle meningeal artery, Embolization
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMiddle meningeal artery embolization
Middle meningeal artery embolization with coil.
Sponsors
The Affiliated Hospital Of Guizhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Self-control
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
： 1. Voluntary written informed consent. 2. Age 18\ 80 years old (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
： 1. 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. 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 | Description |
|---|---|---|
| Headache attack frequency (times / month and Headache duration） | At baseline, 90 days after treatment | Record of headache attack frequency (times / month and Headache duration） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of medication in acute phase and dosage | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment | Record of days of medication in acute phase and dosage |
| Severity of headache:Visual Analogue Scale | At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment | 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) |
| Severity of headache:Numerical Rating Scale | At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment | The headache level is rated from 0 (no pain) to 10 (the most severe) |
| Headache aura(nausea,photophobia,phonophobia) frequency | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment | Record of headache aura |
| Headache attack frequency (days / month) | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment | Record of headache attack frequency (days / month) |
| Headache Impact | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment | Headache Impact Test (HIT-6) |
| Migraine-Specific Questionnaire | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment | Migraine-Specific Questionnaire（MSQ） |
| Hospital Anxiety and Depression | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment | Hospital Anxiety and Depression Scale(HADS) |
| Clinical Global Impression | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment | Clinical Global Impression(CGI) |
| Migraine Disability Assessment | At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment | The Migraine Disability Assessment questionnaire (MIDAS) |
Countries
China
Outcome results
None listed