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

• Lidocaine (drug) (Drug), also known as Xylocaine: Intra-arterial lidocaine infusion into bilateral middle meningeal arteries
• Saline (Drug), also known as Fluids: Intra-arterial saline infusion into bilateral middle meningeal arteries

Primary outcomes

• Change in Headache Impact Test-6 Scores (1 Month) [From baseline to 1 month follow-up]: Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms

Secondary outcomes

• Change in Numeric Pain Scores [From baseline to periprocedural]: Difference in Numeric Pain Scores (0-10), with larger decreases in scores correlating with improvement in symptoms
• Change in Migraine Disability Assessment Scores [From baseline to 3 month follow-up]: Difference in Migraine Disability Assessment Scores, with larger decreases in scores correlating with improvement in symptoms
• Change in Headache Impact Test-6 Scores Over Time (2 Months) [From baseline to 2 month follow-up]: Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms
• Change in Headache Impact Test-6 Scores Over Time (3 Months) [From baseline to 3 month follow-up]: Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms
• Proportion with Substantial or Severe Headache Impact Test-6 Scores (1 Month) [From baseline to 1 month follow-up]: Proportion of patients with substantial (56-59) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms
• Proportion with Substantial or Severe Headache Impact Test-6 Scores (2 Months) [From baseline to 2 month follow-up]: Proportion of patients with substantial (56-59) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms
• Proportion with Substantial or Severe Headache Impact Test-6 Scores (3 Months) [From baseline to 3 month follow-up]: Proportion of patients with substantial (56-69) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms
• Proportion with Low Patient Global Impression of Change Scores (Post-Treatment) [From baseline to periprocedural]: Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms
• Proportion with Low Patient Global Impression of Change Scores (1 Month) [From baseline to 1 month follow-up]: Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms
• Proportion with Low Patient Global Impression of Change Scores (2 Months) [From baseline to 2 month follow-up]: Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms
• Proportion with Low Patient Global Impression of Change Scores (3 Months) [From baseline to 3 month follow-up]: Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms
• Related or Serious Adverse Events [From post-treatment to 1 week]: Incidence of related adverse events or serious adverse events
• New Stroke or All-Cause Death [From post-treatment to 1 month follow-up]: Incidence of new, disabling stroke or death from any cause

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age 18 years or above
* Diagnosis of chronic migraine
* Referred for diagnostic cerebral angiography to screen for intracranial pathology
* Written informed consent able to be obtained from subject

Exclusion Criteria:

* Baseline HIT-6 score less than 50
* 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

• Koneru M, Shaikh HA, Khalife J, Syrow L, Santucci J, Ballout AA, Patel PD, Thomas AJ, Jovin TG, Tonetti DA. Localized Injection of Lidocaine and Glucocorticoid for Refractory Headache Treatment (LIGHT): A Phase 1 Clinical Trial for Safety. Stroke Vasc Interv Neurol. 2025 Oct 29;5(6):e001966. doi: 10.1161/SVIN.125.001966. eCollection 2025 Nov. No abstract available. PMID 41608705