Actively Recruiting
A Pilot Study of Safety and Feasibility of Bilateral Middle Meningeal Artery Embolization in Patients With Refractory Chronic Migraine Headache
Led by Johns Hopkins University · Updated on 2026-05-04
13
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of embolizing the middle meningeal arteries (MMA) using a product called Onyx for patients with refractory chronic migraine. This procedure is not currently approved for migraines but is used for subdural hematomas. The study aims to reduce migraine-causing substances in the brain's bloodstream by blocking these arteries. The supplies are provided by Medtronic, and the study is sponsored by Johns Hopkins University. Participants will undergo a procedure called bilateral embolization of the middle meningeal arteries with Onyx. After the procedure, participants will be followed for about 6 months, with the total study participation lasting around 8 months. During this time, participants will continue their regular migraine medications and keep a daily headache diary. Several clinic visits will be scheduled, and blood samples will be collected for research purposes. Throughout the study, participants will attend multiple clinic visits for assessments and provide blood samples. They will also maintain a daily headache diary to track migraine symptoms. The primary outcome measured is the number of specific adverse events related to the procedure within 30 days after embolization. Safety and feasibility will be carefully monitored during the follow-up period to understand the procedure's impact on refractory chronic migraine.
CONDITIONS
Brief Title
Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed with chronic migraine according to ICHD3 criteria with symptoms on both sides of the head
- Refractory chronic migraine defined by inadequate response, failure, or intolerance to at least two classes of migraine preventatives
- Chronic migraines lasting at least 12 months before enrollment and at least 6 months after failing two classes of medication
- No use of opiates or barbiturates for migraine treatment
- No secondary headache disorders causing symptoms, confirmed by MRI/MRA within 3 years
- At least one migraine-free day in the last month recorded in a headache diary
- Minimum MIDAS score of 21 indicating severely disabling migraine
- Able to read and write English
- Able to sign informed consent and complete study follow-up requirements
You will not qualify if you...
- History of cranial or cervical vascular interventions or surgeries including craniotomy, shunt placement, or carotid endarterectomy
- Use of opiates or barbiturates for chronic migraine treatment within one year
- Current intracranial lesions found by routine MRI
- History of cranial radiation treatment
- Diagnoses of other headache types such as hemiplegic migraine, basilar migraine, new daily persistent headache, or cluster headache
- Significant liver impairment or serum creatinine above 2.0 mg/dL unless on dialysis
- History of systemic malignancy or autoimmune inflammatory disorders
- Life-threatening allergy to radiographic contrast not manageable medically
- Participation in other migraine studies that could affect this trial's results
- Medical or social issues that could interfere with study completion
- Patients with episodic migraine due to effective therapy are not eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants will undergo embolization of the middle meningeal arteries with Onyx.
1 visit (in-person)
Duration - 30 days
Participants are monitored for safety and adverse events following the embolization procedure.
Approximately 1 follow-up visit within 30 days after procedure
Trial Site Locations
Total: 1 location
1
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
K
Kelly Szajna
K
Kallan Dirmeyer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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