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

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Procedure: Middle meningeal artery embolization

• Registration Number: NCT06029153
• Lead Sponsor: The Affiliated Hospital Of Guizhou Medical University

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.

Study Timeline

• Study Start: 2023-06-15
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Status Verified: 2024-05
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Last Update Submitted: 2024-12-28
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Middle meningeal artery embolization	Middle meningeal artery embolization	Middle meningeal artery embolization with coil.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
Migraine Disability Assessment	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment	The Migraine Disability Assessment questionnaire (MIDAS)
Hospital Anxiety and Depression	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment	Hospital Anxiety and Depression Scale(HADS)
Migraine-Specific Questionnaire	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment	Migraine-Specific Questionnaire（MSQ）
Clinical Global Impression	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment	Clinical Global Impression(CGI)

Trial Locations

Locations (1)

The Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China