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

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)

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Key information

Conditions

Refractory Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location contact

Cooper University Health Care

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lidocaine (drug)

Drug

Intra-arterial lidocaine infusion into bilateral middle meningeal arteries

Other names: Xylocaine

Saline

Drug

Intra-arterial saline infusion into bilateral middle meningeal arteries

Other names: Fluids

Primary outcomes

Change in Headache Impact Test-6 Scores

Time frame: From baseline to 4 week follow-up

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

Sponsors and collaborators

Lead sponsor

Daniel A Tonetti, MD

Other

Registry information

Official study title

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

Acronym: LIGHT 2

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2031
First posted: Jan 23, 2026
Registry last updated: Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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