What is the embolization treatment studying for chronic resistant migraine?

This clinical trial is studying whether blocking certain arteries in the head using SQUID 12 and SQUID 18 materials can reduce the number and severity of migraines in adults with chronic resistant migraine. The research aims to find new treatment options for patients whose migraines have not improved with other methods. The study is sponsored by Vedanta University Clinic.

Who may be eligible for this chronic resistant migraine clinical trial?

Adults aged 35 to 59 with a diagnosis of chronic migraine lasting at least 12 months may be eligible. Participants must have frequent migraine days despite trying various treatments and be able to use adequate contraception if applicable. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic resistant migraine clinical trial?

Study-related care, including the embolization procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Early Phase 1

Age: 35Years - 59Years

All Genders

ID06848166

Effectiveness and Safety of Middle Meningeal Artery Embolization Using SQUID 12 and SQUID 18 Devices for Treating Chronic Resistant Migraine in Adults Aged 35 to 59

Led by Vedanta University Clinic · Updated on 2025-02-26

Participants Needed

Research Sites

30 weeks

Total Duration

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

Age: 35Years - 59Years

All Genders

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.

Research Team

Andrey E Petrov, MD, PhD

Andrey S Dakovskiy, MD

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Effectiveness and Safety of Middle Meningeal Artery Embolization Using SQUID 12 and SQUID 18 Devices for Treating Chronic Resistant Migraine in Adults Aged 35 to 59

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria