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Recruiting NCT07361549

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

Conditions: Refractory Migraine, Headache

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 80
Sponsor: Daniel A Tonetti, MD

Location: Cooper University Health Care Camden New Jersey

Summary

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)

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07361549). StuddyBuddy aggregates publicly available trial information.