Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine (NCT07223008)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (13 items).
Location: Johns Hopkins Medicine — Baltimore, Maryland
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria:
- History of cranial or cervical vascular interventions or surgery, including craniotomy/craniectomy, shunt placement, stereoelectroencephalography, and carotid endarterectomy.
- A history of opiate or barbiturate use for the treatment of chronic migraine within one year.
- Current intracranial lesions as determined by routine care MRI for exclusion of secondary headache disorders.
- History of cranial radiation treatment.
- Patients with additional diagnoses under ICHD3 (such as hemiplegic migraine, basilar migraine, new daily persistent headache, or cluster headache) are ineligible
- Significant liver function impairment or serum creatinine \> 2.0 mg/dL. Patients with elevated creatinine levels who are on dialysis may be eligible.
- History of systemic malignancy or auto-immune inflammatory disorders (such as multiple sclerosis, rheumatoid arthritis, autoimmune diseases).
- History of life-threatening allergy to radiographic contrast. Patients with this allergy may be eligible if it can be managed medically.
- Enrollment in another migraine study which could confound this study's endpoints, including undergoing any intervention or receiving an experimental drug under investigation for migraine therapy.
- Additional medical or social concerns which could confound this study's endpoints or otherwise create undue risk or interfere with the participant's ability to complete the study, as assessed by the PI.
- As this study is open only to patients with chronic migraine, which is refractory to treatment, patients who have previously been diagnosed with chronic migraine but now experience episodic migraine due to effective therapy are not eligible.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Johns Hopkins Medicine — Baltimore, Maryland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.