Actively Recruiting
Study of the Effectiveness and Safety of Embolization of the Middle Meningeal Artery Using Non-adhesive Materials SQUID 12 and SQUID 18 in the Treatment of Patients With Chronic Resistant Migraine
Led by Vedanta University Clinic · Updated on 2025-02-26
30
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of embolizing the middle meningeal artery (MMA) using non-adhesive materials SQUID 12 and SQUID 18 in patients with chronic resistant migraine. This early phase study focuses on patients aged 35 to 59 who have had chronic migraines for at least a year and have not responded to other treatments. The goal is to see if this embolization procedure can reduce the number and severity of migraine days. The study involves a total endovascular embolization of specific branches of the middle meningeal artery depending on the location of migraine pain. If the migraine is on one side, the corresponding artery branch will be embolized; if on both sides, both branches will be treated. The procedure aims to fully block blood flow in these branches using SQUID 12 and SQUID 18 materials. Participants will be monitored for up to 12 months after the embolization procedure. Researchers will track the number of migraine days, headache days, headache intensity, and associated symptoms like nausea or sensitivity to light and sound. Various scales including HIT-6 and MIDAS will assess the impact on daily life. Safety will also be closely observed through regular visits and assessments throughout the study period.
CONDITIONS
Brief Title
Study of the Effectiveness and Safety of Embolization of the Middle Meningeal Artery Using Non-adhesive Materials SQUID 12 and SQUID 18 in the Treatment of Patients With Chronic Resistant Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient has read, understood, and signed the informed consent form.
- Aged between 35 and 59 years inclusive at consent.
- Diagnosed with chronic migraine at least 12 months before screening.
- Migraine is resistant as defined by European Headache Federation criteria for at least 6 months.
- Experienced at least 14 headache days in 28 days, with 8 days qualifying as migraine.
- History of migraine resistant to both pharmacological and non-pharmacological treatments.
- Headache intensity during migraine days is 5 or higher on a 10-point scale during screening.
- No positive response to previous botulinum toxin therapy (OnabotulinumtoxinA) per PREEMPT protocol.
- Consent to use effective contraception and not serve as egg/sperm donor during the study (for participants with reproductive potential).
You will not qualify if you...
- Contraindications to middle meningeal artery embolization.
- Allergies to contrast agents used during embolization.
- History of brain vascular malformations, aneurysms, tumors, hydrocephalus, or severe brain injuries.
- History of skull base fractures or neurosurgical operations.
- Mental illness affecting study participation or safety.
- History of hyperthyroidism, diabetes, or other endocrine disorders affecting participation.
- History of drug addiction, alcoholism, or medication abuse.
- Medication-induced headache within 3 months before screening.
- Other types of chronic headache within 12 months before screening.
- Inability to distinguish migraine from other headache types.
- Migraine complications like status migrainosus or persistent aura.
- Body mass index below 18.5 or above 39.9 kg/m².
- Migraine onset after age 50.
- Metabolic syndrome or cachexia.
- Severe cardiovascular diseases or uncontrolled hypertension.
- Varicose veins or history of vein thrombosis.
- Ischemic heart disease or atherosclerosis.
- History of stroke or cerebrovascular accident.
- Pregnancy or plans to become pregnant within 3 months.
- Atrial fibrillation, heart anomalies, or heart surgeries.
- Blood clotting disorders or anticoagulant use within 5 days before procedure.
- Uncontrolled asthma or severe COPD.
- Renal or liver insufficiency.
- History of generalized pain syndrome or fibromyalgia.
- Women using combined oral contraceptives with thrombosis history.
- History of epilepsy or neurological conditions other than migraine.
- Positive tests or history of HIV, hepatitis B/C, or syphilis.
- Recent or current cancer.
- Other serious medical or psychological conditions affecting participation.
- Participation in other interventional clinical trials within 30 days before screening.
- Inability to comply with study procedures or protocol.
- Employees or relatives of the medical institution or sponsor involved in the study.
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 undergo total endovascular embolization of the middle meningeal artery using non-adhesive liquid embolic agents SQUID 12 or SQUID 18 to treat chronic resistant migraine.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for effectiveness and safety after the embolization procedure, including assessment of migraine and headache days and intensity over a 12-month period.
Visits at 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months post-procedure (in-person)
Trial Site Locations
Total: 1 location
1
Vedanta University Clinic
Bishkek, Bishkek, Kyrgyzstan, 720054
Actively Recruiting
Research Team
A
Andrey E Petrov, MD, PhD
A
Andrey S Dakovskiy, MD
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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