Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment

Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment: A Randomized, Double-Blinded, Parallel Phase 2 Clinical Trial

The goal of this clinical trial is to test whether injecting lidocaine into two blood vessels of the brain can help treat chronic headaches (migraines)

Inclusion Criteria:

• Age 18 years or above
• Referred for diagnostic angiography
• Diagnosis of intractable migraine
• Written informed consent able to be obtained from subject

Exclusion Criteria:

• Baseline HIT-6 score less than 60 (severe)
• Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• Concomitant intracranial pathology (eg, intracranial malignancy)
• Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type
• Taking chronic medications that, when co-administered with lidocaine and other local anesthetics, are at increased risk of developing methemoglobinemia (nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, acetaminophen, metoclopramide, quinine, sulfasalazine)
• Known contraindications for angiography (eg, ESRD not requiring hemodialysis). Patients with contrast allergy with be premeditated with diphenhydramine and steroids.
• Contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC)
• Concurrent participation in another research protocol for investigation of an experimental therapy
• Per DSA imaging, presence of a cerebrovascular pathology known to cause headache (eg, arteriovenous malformation, dural arteriovenous fistula)
• Per DSA imaging, presence of anastomosis or anatomical variation (eg, branches of middle meningeal artery) that could lead to increased procedural risk
• Per DSA imaging, lack of endovascular access to either middle meningeal artery, or origin of the middle meningeal artery other than from the external carotid artery
• Known or suspected inability to adhere to study protocol or protocol requirements, as per discretion of the Investigator or treating provider