Localized lidocaine injection into the middle meningeal artery for chronic migraine relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with chronic migraine who have not found relief with standard treatments will receive lidocaine injections into two brain arteries during diagnostic angiography. The study compares lidocaine to saline to see if the approach can lessen headache frequency or severity. Researchers will monitor safety and collect data on headache impact and potential adverse effects. Participation requires informed consent and adherence to safety criteria, including assessments for intracranial pathology. The trial is led by Daniel A. Tonetti, MD, with SNIS Foundation and Stryker Neurovascular collaborators at Cooper University Health Care in Camden, NJ.

Why it matters

Who can join: the full rules

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

Where it's running

• Cooper University Health Care
  Camden, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Daniel A Tonetti, MD
• Email: tonetti-daniel@cooperhealth.edu
• Phone: (855) 306-3876

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.