MigraineFAST-EM-2NCT07633067
Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine.
A study testing Middle meningeal artery embolization and Conventional standard pharmacotherapy for migraine in people with Migraine, run by The Affiliated Hospital Of Guizhou Medical University.
Trial summary
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine
- What is being tested?
- Middle meningeal artery embolization and Conventional standard pharmacotherapy for migraine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~80 years old (inclusive), regardless of gender.
- Voluntary written informed consent.
- Migraine diagnosed by neurologists/pain specialists according to the current International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria for migraine with or without aura.
- Migraine attack frequency of no less than 4 days per month within one month prior to enrollment.
- History of pharmacotherapy for migraine prophylaxis or treatment for at least 6 months.
Who cannot join
- Findings on cerebral angiography indicating secondary headache due to intracranial vascular disorders, including dural arteriovenous fistula, arteriovenous malformation, venous malformation, or other relevant cerebrovascular lesions; Moyamoya disease; or high-risk vascular anatomical variants unsuitable for safe vascular access or contraindicating MMA embolization.
- Complicated with cervical spondylosis and secondary headache of otogenic, rhinogenic, odontogenic origin; patients with a history of trigeminal autonomic cephalalgias; headache with other definite etiologies or secondary headache;
- Imaging diagnosis shows acute or chronic subdural hematoma, other acute intracranial lesions and other space-occupying lesions;
- Patients planning to undergo surgery within 90 days;
- Patients with a life expectancy of less than 12 months;
- Patients with a definite history of contrast media allergy;
Show all 14Show fewer
- Patients with a history of opioid addiction;
- Breastfeeding or pregnant women, or patients with fertility plans within half a year;
- Subjects who participated in other clinical trials of drugs or medical devices before enrollment and did not reach the time limit of the primary study endpoint;
- Unable to understand headache-related assessment data such as headache diaries and requiring assistance from others to complete them;
- Patients with poor compliance judged by the investigator and unable to complete the study as required;
- Patients with a definite history of allergy to embolization materials such as nitinol alloy and/or cobalt-based alloy, platinum-tungsten alloy, etc.;
- Subjects with other comorbidities that restrict their participation in the study, prevent compliance with follow-up, or affect the scientific integrity of the study;
- Other conditions in which the investigator considers the patient inappropriate to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine: A Multicenter, Prospective, Double-blind, Multigroup, Randomized Controlled Trial.
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.
Read the detailed description
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.This study will enroll 150 subjects with a long history of headache from multiple clinical centers, who will be randomly assigned using a stratified randomization method via computer and web-based software. Stratified randomization will be performed according to study centers (different sub-centers). Subjects will be randomly allocated in a 1:1:1 ratio to the unilateral embolization group, bilateral embolization group, or conventional pharmacotherapy group (hereinafter referred to as the "control group"), with 50 subjects in each group. The unilateral embolization group will receive unilateral MMA interventional embolization plus conventional pharmacotherapy, the bilateral embolization group will receive bilateral MMA interventional embolization plus conventional pharmacotherapy, and the control group will receive only conventional standard pharmacotherapy. Baseline data prior to randomization and data on primary and secondary endpoint scores will be collected for all enrolled subjects. Regular follow-up will be conducted to evaluate the recovery of headache.
- Conditions
- Migraine
- Being tested
- Middle meningeal artery embolization, Conventional standard pharmacotherapy for migraine
- Keywords
- Migraine, Middle meningeal artery, Embolization
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle meningeal artery embolizationProcedure or surgery
Middle meningeal artery embolization with coils.
Conventional standard pharmacotherapy for migraineDrug
Conventional standard pharmacotherapy for migraine
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy | Experimental | Subjects in this arm will receive unilateral middle meningeal artery embolization with coils plus conventional standard pharmacotherapy for migraine. Receives: Procedure: Middle meningeal artery embolization; Drug: Conventional standard pharmacotherapy for migraine |
| Bilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy | Experimental | Subjects in this arm will receive bilateral middle meningeal artery embolization with coils plus conventional standard pharmacotherapy for migraine. Receives: Procedure: Middle meningeal artery embolization; Drug: Conventional standard pharmacotherapy for migraine |
| Conventional Standard Pharmacotherapy | Active comparator | Subjects in this arm will receive only conventional standard pharmacotherapy for migraine, without any middle meningeal artery embolization intervention. Receives: Drug: Conventional standard pharmacotherapy for migraine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine attack frequency (days / month)
Change from baseline in the mean number of migraine days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
Measured: :At baseline,within 90 days, 90-day, 180-day after treatment
Secondary outcomes (9)
Migraine attack frequency (times / month)
Change from baseline in the mean number of migraine attacks per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
Measured: At baseline, within 90 days, 90-day, 180-day after treatment
Total headache frequency (days / month)
Change from baseline in the mean number of all headache days per month within 90 days after randomization.
Measured: At baseline, within 90 days after treatment
Migraine medication use frequency (days / month)
Change from baseline in the mean number of migraine medication use days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
Measured: At baseline, within 90 days, 90-day, 180-day after treatment
Proportion of ≥50% reduction in migraine days (days/month)
Proportion of participants with at least a 50% reduction from baseline in the mean number of migraine days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
Measured: At baseline, within 90 days, 90-day, 180-day after treatment
Numerical Rating Scale for migraine pain severity (NRS) (score/month)
Change from baseline in the mean monthly Migraine Pain Severity Score (NRS) within 90 days and within 180 days after randomization.
Measured: At baseline, within 90 days, 180 days after treatment
Migraine Disability Assessment Questionnaire (MIDAS) (score/month)
Change from baseline in the mean monthly Migraine Disability Assessment Score (MIDAS) within 90 days and within 180 days after randomization.
Measured: At baseline, within 90 days, 180 days after treatment
Clinical Global Impression Scale (CGI) (score/month)
Change from baseline in the mean monthly Clinical Global Impression (CGI) Scale score within 90 days and within 180 days after randomization.
Measured: At baseline, within 90 days, 180 days after treatment
Headache Impact Test (HIT-6) (score/month)
Change from baseline in the mean monthly Headache Impact Test-6 (HIT-6) score within 90 days and within 180 days after randomization.
Measured: At baseline, within 90 days, 180 days after treatment
Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) (score/month)
Change from baseline in the mean monthly Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1) score within 90 days and within 180 days after randomization.
Measured: At baseline, within 90 days, 180 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Action Medical Technology Co., Ltd., Juhui Medical Technology (Shenzhen) Co., Ltd., Beijing Xinke Medical Technology Co., Ltd.
- Responsible party
- Principal investigator, Zeguang Ren, The Affiliated Hospital Of Guizhou Medical University
- Investigators
- Zeguang Ren, MD. PhD., Study chair, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633067
- Sponsor's protocol ID
- FAST-EM-2
- Acronym
- FAST-EM-2
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tempaku A, Yamauchi S, Ikeda H, Tsubota N, Furukawa H, Maeda D, Kondo K, Nishio A. Usefulness of interventional embolization of the middle meningeal artery for recurrent chronic subdural hematoma: Five cases and a review of the literature. Interv Neuroradiol. 2015 Jun;21(3):366-71. doi: 10.1177/1591019915583224. Epub 2015 May 26.
PubMed 26015518Levy D, Moskowitz MA. Meningeal Mechanisms and the Migraine Connection. Annu Rev Neurosci. 2023 Jul 10;46:39-58. doi: 10.1146/annurev-neuro-080422-105509. Epub 2023 Mar 13.
PubMed 36913712Lam A, Selvarajah D, Htike SS, Chan S, Lalloo S, Lock G, Redmond K, Leggett D, Mews P. The efficacy of postoperative middle meningeal artery embolization on chronic subdural hematoma - A multicentered randomized controlled trial. Surg Neurol Int. 2023 May 12;14:168. doi: 10.25259/SNI_208_2023. eCollection 2023.
PubMed 37292400Xu K, Cui J, Demiraj F, Chen G, Wang Q, Mokin M, Yan Z, Peng H, Huang Y, Peng Z, Xiang X, Chu L, Wu S, Song S, Zheng Y, Wang L, Cai J, Shao Y, Yao Y, Yang H, Ren Z. Middle meningeal artery embolization for migraine headaches - a prospective self-control cohort trial. Int J Surg. 2026 Feb 1;112(2):3399-3411. doi: 10.1097/JS9.0000000000003714. Epub 2025 Nov 4.
PubMed 41186515Catapano JS, Karahalios K, Srinivasan VM, Baranoski JF, Rutledge C, Cole TS, Ducruet AF, Albuquerque FC, Jadhav AP. Chronic headaches and middle meningeal artery embolization. J Neurointerv Surg. 2022 Mar;14(3):301-303. doi: 10.1136/neurintsurg-2021-017602. Epub 2021 Apr 22.
PubMed 33888570Valdueza JM, Dreier JP, Woitzik J, Dohmen C, Sakowitz O, Platz J, Leistner-Glaess S, Witt VD. Course of Preexisting Migraine Following Spontaneous Subarachnoid Hemorrhage. Front Neurol. 2022 Jul 11;13:880856. doi: 10.3389/fneur.2022.880856. eCollection 2022.
PubMed 35899261Fan Z, Fan Z, Wang H. New surgical approach for migraine. Otol Neurotol. 2006 Aug;27(5):713-5. doi: 10.1097/01.mao.0000226304.66822.6d.
PubMed 16868520Mancuso-Marcello M, Qureshi AI, Nikola C, Stoian I, Jia Y, Saeed D, Bhogal P. Intra-arterial lidocaine therapy via the middle meningeal artery for migraine headache: Theory, current practice and future directions. Interv Neuroradiol. 2026 Feb;32(1):104-108. doi: 10.1177/15910199231195470. Epub 2023 Aug 13.
PubMed 37574789Qureshi AI, Pfeiffer K, Babar S, Huang W, Lobanova I, Ishfaq MF, French BR, Siddiq F, Gomez CR. Intra-arterial injection of lidocaine into middle meningeal artery to treat intractable headaches and severe migraine. J Neuroimaging. 2021 Nov;31(6):1126-1134. doi: 10.1111/jon.12918. Epub 2021 Aug 13.
PubMed 34388298Qureshi AI, Qureshi MH, Khan AA, Suri MF. Effect of intra-arterial injection of lidocaine and methyl-prednisolone into middle meningeal artery on intractable headaches. J Vasc Interv Neurol. 2014 Dec;7(5):69-72.
PubMed 25566345Asghar MS, Hansen AE, Amin FM, van der Geest RJ, Koning Pv, Larsson HB, Olesen J, Ashina M. Evidence for a vascular factor in migraine. Ann Neurol. 2011 Apr;69(4):635-45. doi: 10.1002/ana.22292. Epub 2011 Mar 17.
PubMed 21416486Vanzin JR, Manzato LB. Chronic migraine and bilateral occlusion of the middle meningeal artery. Interv Neuroradiol. 2025 Jun 2:15910199251337520. doi: 10.1177/15910199251337520. Online ahead of print.
PubMed 40452399Christensen CE, Younis S, Lindberg U, Boer VO, de Koning P, Petersen ET, Paulson OB, Larsson HBW, Amin FM, Ashina M. Ultra-high field MR angiography in human migraine models: a 3.0 T/7.0 T comparison study. J Headache Pain. 2019 May 6;20(1):48. doi: 10.1186/s10194-019-0996-x.
PubMed 31060491Christensen CE, Younis S, Lindberg U, de Koning P, Tolnai D, Paulson OB, Larsson HBW, Amin FM, Ashina M. Intradural artery dilation during experimentally induced migraine attacks. Pain. 2021 Jan;162(1):176-183. doi: 10.1097/j.pain.0000000000002008.
PubMed 32701652Asghar MS, Hansen AE, Kapijimpanga T, van der Geest RJ, van der Koning P, Larsson HB, Olesen J, Ashina M. Dilation by CGRP of middle meningeal artery and reversal by sumatriptan in normal volunteers. Neurology. 2010 Oct 26;75(17):1520-6. doi: 10.1212/WNL.0b013e3181f9626a.
PubMed 20975053
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine: A Multicenter, Prospective, Double-blind, Multigroup, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07633067
- Acronym / sponsor ID
- FAST-EM-2 / FAST-EM-2
- Conditions
- Migraine
- Keywords
- Migraine, Middle meningeal artery, Embolization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Collaborators
- Sichuan Action Medical Technology Co., Ltd., Juhui Medical Technology (Shenzhen) Co., Ltd., Beijing Xinke Medical Technology Co., Ltd.
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.
Detailed description
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.This study will enroll 150 subjects with a long history of headache from multiple clinical centers, who will be randomly assigned using a stratified randomization method via computer and web-based software. Stratified randomization will be performed according to study centers (different sub-centers). Subjects will be randomly allocated in a 1:1:1 ratio to the unilateral embolization group, bilateral embolization group, or conventional pharmacotherapy group (hereinafter referred to as the "control group"), with 50 subjects in each group. The unilateral embolization group will receive unilateral MMA interventional embolization plus conventional pharmacotherapy, the bilateral embolization group will receive bilateral MMA interventional embolization plus conventional pharmacotherapy, and the control group will receive only conventional standard pharmacotherapy. Baseline data prior to randomization and data on primary and secondary endpoint scores will be collected for all enrolled subjects. Regular follow-up will be conducted to evaluate the recovery of headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Unilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy | Experimental | Procedure: Middle meningeal artery embolization, Drug: Conventional standard pharmacotherapy for migraineSubjects in this arm will receive unilateral middle meningeal artery embolization with coils plus conventional standard pharmacotherapy for migraine. |
| Bilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy | Experimental | Procedure: Middle meningeal artery embolization, Drug: Conventional standard pharmacotherapy for migraineSubjects in this arm will receive bilateral middle meningeal artery embolization with coils plus conventional standard pharmacotherapy for migraine. |
| Conventional Standard Pharmacotherapy | Active comparator | Drug: Conventional standard pharmacotherapy for migraineSubjects in this arm will receive only conventional standard pharmacotherapy for migraine, without any middle meningeal artery embolization intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18~80 years old (inclusive), regardless of gender.
- Voluntary written informed consent.
- Migraine diagnosed by neurologists/pain specialists according to the current International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria for migraine with or without aura.
- Migraine attack frequency of no less than 4 days per month within one month prior to enrollment.
- History of pharmacotherapy for migraine prophylaxis or treatment for at least 6 months.
Key exclusion criteria (14 listed)
- Findings on cerebral angiography indicating secondary headache due to intracranial vascular disorders, including dural arteriovenous fistula, arteriovenous malformation, venous malformation, or other relevant cerebrovascular lesions; Moyamoya disease; or high-risk vascular anatomical variants unsuitable for safe vascular access or contraindicating MMA embolization.
- Complicated with cervical spondylosis and secondary headache of otogenic, rhinogenic, odontogenic origin; patients with a history of trigeminal autonomic cephalalgias; headache with other definite etiologies or secondary headache;
- Imaging diagnosis shows acute or chronic subdural hematoma, other acute intracranial lesions and other space-occupying lesions;
- Patients planning to undergo surgery within 90 days;
- Patients with a life expectancy of less than 12 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle meningeal artery embolizationMiddle meningeal artery embolization with coils. | Procedure or surgery | Bilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy, Unilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy |
| Conventional standard pharmacotherapy for migraineConventional standard pharmacotherapy for migraine | Drug | Bilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy, Conventional Standard Pharmacotherapy, Unilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy |
Primary outcome
Migraine attack frequency (days / month)
Time frame: :At baseline,within 90 days, 90-day, 180-day after treatment
Change from baseline in the mean number of migraine days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
9 secondary outcomes
Migraine attack frequency (times / month)
Time frame: At baseline, within 90 days, 90-day, 180-day after treatment
Total headache frequency (days / month)
Time frame: At baseline, within 90 days after treatment
Migraine medication use frequency (days / month)
Time frame: At baseline, within 90 days, 90-day, 180-day after treatment
Proportion of ≥50% reduction in migraine days (days/month)
Time frame: At baseline, within 90 days, 90-day, 180-day after treatment
Numerical Rating Scale for migraine pain severity (NRS) (score/month)
Time frame: At baseline, within 90 days, 180 days after treatment
Migraine Disability Assessment Questionnaire (MIDAS) (score/month)
Time frame: At baseline, within 90 days, 180 days after treatment
Clinical Global Impression Scale (CGI) (score/month)
Time frame: At baseline, within 90 days, 180 days after treatment
Headache Impact Test (HIT-6) (score/month)
Time frame: At baseline, within 90 days, 180 days after treatment
Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) (score/month)
Time frame: At baseline, within 90 days, 180 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 26015518Tempaku A, Yamauchi S, Ikeda H, Tsubota N, Furukawa H, Maeda D, Kondo K, Nishio A. Usefulness of interventional embolization of the middle meningeal artery for recurrent chronic subdural hematoma: Five cases and a review of the literature. Interv Neuroradiol. 2015 Jun;21(3):366-71. doi: 10.1177/1591019915583224. Epub 2015 May 26.
- Background: PubMed 36913712Levy D, Moskowitz MA. Meningeal Mechanisms and the Migraine Connection. Annu Rev Neurosci. 2023 Jul 10;46:39-58. doi: 10.1146/annurev-neuro-080422-105509. Epub 2023 Mar 13.
- Background: PubMed 37292400Lam A, Selvarajah D, Htike SS, Chan S, Lalloo S, Lock G, Redmond K, Leggett D, Mews P. The efficacy of postoperative middle meningeal artery embolization on chronic subdural hematoma - A multicentered randomized controlled trial. Surg Neurol Int. 2023 May 12;14:168. doi: 10.25259/SNI_208_2023. eCollection 2023.
- Background: PubMed 41186515Xu K, Cui J, Demiraj F, Chen G, Wang Q, Mokin M, Yan Z, Peng H, Huang Y, Peng Z, Xiang X, Chu L, Wu S, Song S, Zheng Y, Wang L, Cai J, Shao Y, Yao Y, Yang H, Ren Z. Middle meningeal artery embolization for migraine headaches - a prospective self-control cohort trial. Int J Surg. 2026 Feb 1;112(2):3399-3411. doi: 10.1097/JS9.0000000000003714. Epub 2025 Nov 4.
- Background: PubMed 33888570Catapano JS, Karahalios K, Srinivasan VM, Baranoski JF, Rutledge C, Cole TS, Ducruet AF, Albuquerque FC, Jadhav AP. Chronic headaches and middle meningeal artery embolization. J Neurointerv Surg. 2022 Mar;14(3):301-303. doi: 10.1136/neurintsurg-2021-017602. Epub 2021 Apr 22.
- Background: PubMed 35899261Valdueza JM, Dreier JP, Woitzik J, Dohmen C, Sakowitz O, Platz J, Leistner-Glaess S, Witt VD. Course of Preexisting Migraine Following Spontaneous Subarachnoid Hemorrhage. Front Neurol. 2022 Jul 11;13:880856. doi: 10.3389/fneur.2022.880856. eCollection 2022.
- Background: PubMed 16868520Fan Z, Fan Z, Wang H. New surgical approach for migraine. Otol Neurotol. 2006 Aug;27(5):713-5. doi: 10.1097/01.mao.0000226304.66822.6d.
- Background: PubMed 37574789Mancuso-Marcello M, Qureshi AI, Nikola C, Stoian I, Jia Y, Saeed D, Bhogal P. Intra-arterial lidocaine therapy via the middle meningeal artery for migraine headache: Theory, current practice and future directions. Interv Neuroradiol. 2026 Feb;32(1):104-108. doi: 10.1177/15910199231195470. Epub 2023 Aug 13.
- Background: PubMed 34388298Qureshi AI, Pfeiffer K, Babar S, Huang W, Lobanova I, Ishfaq MF, French BR, Siddiq F, Gomez CR. Intra-arterial injection of lidocaine into middle meningeal artery to treat intractable headaches and severe migraine. J Neuroimaging. 2021 Nov;31(6):1126-1134. doi: 10.1111/jon.12918. Epub 2021 Aug 13.
- Background: PubMed 25566345Qureshi AI, Qureshi MH, Khan AA, Suri MF. Effect of intra-arterial injection of lidocaine and methyl-prednisolone into middle meningeal artery on intractable headaches. J Vasc Interv Neurol. 2014 Dec;7(5):69-72.
- Background: PubMed 21416486Asghar MS, Hansen AE, Amin FM, van der Geest RJ, Koning Pv, Larsson HB, Olesen J, Ashina M. Evidence for a vascular factor in migraine. Ann Neurol. 2011 Apr;69(4):635-45. doi: 10.1002/ana.22292. Epub 2011 Mar 17.
- Background: PubMed 40452399Vanzin JR, Manzato LB. Chronic migraine and bilateral occlusion of the middle meningeal artery. Interv Neuroradiol. 2025 Jun 2:15910199251337520. doi: 10.1177/15910199251337520. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeguang Ren, MD. PhD. study chair
The Affiliated Hospital Of Guizhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Middle meningeal artery embolization and Conventional standard pharmacotherapy for migraine in people with Migraine, run by The Affiliated Hospital Of Guizhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeguang Ren, MD. PhD. (+86 0851-86770232., renzem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine attack frequency (days / month) (time frame: :At baseline,within 90 days, 90-day, 180-day after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07633067, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.