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Lidocaine Injection for Intractable Headache Treatment

This study is testing if injecting lidocaine into two specific blood vessels in the brain (bilateral middle meningeal arteries) can help people with severe, ongoing headaches, including migraines. You might be able to join if you are 18 or older, have been diagnosed with intractable (hard-to-treat) migraine, and are referred for a diagnostic angiography (a type of X-ray to look at blood vessels). The researchers will compare lidocaine to saline (saltwater) injections. The main goal is to see if lidocaine improves your headache impact, measured by your Headache Impact Test-6 (HIT-6) scores over 4 weeks. The current status of this study is unclear, and it plans to enroll 80 participants.

Study design
This interventional study plans to enroll 80 participants. It compares intra-arterial lidocaine infusion to intra-arterial saline infusion.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your headache impact will be measured from the start of the study up to 4 weeks later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07361549

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Daniel A Tonetti, MD
~80 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:Lidocaine (drug)Saline

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Headache Impact Test-6 Scores
Measured over From baseline to 4 week follow-up

Conditions

Refractory Migraine
Headache

Explore related trials

Migraine

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Manisha Koneru, MD · STUDY_CHAIR · The Cooper Health System

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in Headache Impact Test-6 ScoresFrom baseline to 4 week follow-up

    Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms