A Pilot Study of Safety and Feasibility of Bilateral Middle Meningeal Artery Embolization (bMMAE) in Patients With Refractory Chronic Migraine Headache: The MMAE-MIGRAINE Trial
This study is to test the safety and feasibility of a procedure called embolization of the middle meningeal arteries (MMA), using a product called Onyx. Embolization creates a plug in the arteries. MMA embolization with Onyx is not approved for use in patients with migraines, but is currently used in patients with subdural hematomas. The FDA is allowing the use of Onyx in this study. It is thought that by using Onyx to block the middle meningeal arteries, the amount of migraine-causing substances which are released into the brain's bloodstream will be reduced. The company that manufactures Onyx, Medtronic, is providing the supplies for this study. Participants will be in the study for about 8 months after enrolling, including 6 months of follow up after the procedure. The participants will be asked to complete a daily headache diary and continue the participant's regular migraine medications. Participants will also have several clinic visits and be asked to provide blood samples for research.
• Age 18\<x\<80
• Meets ICHD3 criteria for chronic migraine, (ICHD3, 1.3; with inclusion of ICHD3 1.1 and 1.2.1 only), with first migraine before age 50 (in concordance with previously published trials in migraine therapy36,39) . Patients must experience bilateral migraine symptoms.
• Satisfy criteria for refractory chronic migraine defined as failure of, inadequate response to, or inability to tolerate migraine preventatives in at least 2 classes. Migraine preventatives include beta-blockers, calcium channel blockers, anti-convulsants (valproic acid, topiramate), anti-depressants (venlafaxine, amitriptyline), CGRP monoclonal antibodies, botulinum toxin injections. Chronic migraines must have persisted for at least 12 months prior to enrollment and at least 6 months after failing 2 classes of medication.
• Has not used opiates or barbiturates as acute (rescue) therapy for migraine headache. Opiate or barbiturate use for reasons other than migraine is allowed. Other classes of acute migraine medications are acceptable. Acute (rescue, abortive) medications for migraines include acetaminophen, NSAIDs (ibuprofen, naproxen), gepants, triptans, anti-emetics (anti-nausea medications).
• Exclusion of secondary headache disorder which may cause migraines/symptoms, including MRI/MRA (performed as routine care showing no underlying lesion that may be causing headaches, within 3 years of screening).
• At least one migraine free day during the last month per headache diary.
• Minimum MIDAS score of 21 (reflecting severely disabling migraine, in concordance with ongoing MMA lidocaine infusion trial44).
• Able to read/write in English. Patients who are not English language users will not be enrolled as the study assessments are only validated in English.
• Able to sign informed consent for themselves.
• Able to complete study requirements/follow-up as outlined in study plan section 3.6.