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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether injecting lidocaine, a numbing medicine, into two blood vessels in the brain can help treat chronic migraines. It is for adults with chronic migraines who have been referred for a special scan of the brain’s blood vessels.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have been diagnosed with chronic migraines.
  • You have been referred for cerebral angiography, a test of the brain’s blood vessels, to check for problems inside the skull.
  • You can give written consent to join the study.

Who can't join

  • Your starting HIT-6 score, which measures how headaches affect your life, is below 50.
  • You are pregnant, breastfeeding, or unwilling to use birth control during the study.
  • The study doctor thinks a health problem could make the study unsafe or affect the results, or you may not be able to follow study rules.
  • You have another condition inside the skull, such as cancer, or scans show blood vessel problems that cause headaches or make the procedure risky or impossible.
  • You have an allergy or another reason you cannot receive lidocaine, similar numbing medicines, or medicines used to keep you relaxed during the procedure.
  • You regularly take medicines that, when combined with lidocaine, raise the risk of a blood problem that limits how well blood carries oxygen.
  • You cannot safely have angiography. People with a contrast dye allergy will receive diphenhydramine and steroids beforehand.
  • You are in another research study testing an experimental treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NJ