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NCT Number: NCT07361549

Localized Injection of Lidocaine Via the Middle Meningeal Artery for 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 status: Recruiting

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
  • 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

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

  1. Change in Headache Impact Test-6 Scores (1 Month)

    Time frame: From baseline to 1 month follow-up

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

Secondary outcomes

  1. Change in Numeric Pain Scores

    Time frame: From baseline to periprocedural

    Difference in Numeric Pain Scores (0-10), with larger decreases in scores correlating with improvement in symptoms

  2. Change in Migraine Disability Assessment Scores

    Time frame: From baseline to 3 month follow-up

    Difference in Migraine Disability Assessment Scores, with larger decreases in scores correlating with improvement in symptoms

  3. Change in Headache Impact Test-6 Scores Over Time (2 Months)

    Time frame: From baseline to 2 month follow-up

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

  4. Change in Headache Impact Test-6 Scores Over Time (3 Months)

    Time frame: From baseline to 3 month follow-up

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

  5. Proportion with Substantial or Severe Headache Impact Test-6 Scores (1 Month)

    Time frame: From baseline to 1 month follow-up

    Proportion of patients with substantial (56-59) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms

  6. Proportion with Substantial or Severe Headache Impact Test-6 Scores (2 Months)

    Time frame: From baseline to 2 month follow-up

    Proportion of patients with substantial (56-59) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms

  7. Proportion with Substantial or Severe Headache Impact Test-6 Scores (3 Months)

    Time frame: From baseline to 3 month follow-up

    Proportion of patients with substantial (56-69) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms

  8. Proportion with Low Patient Global Impression of Change Scores (Post-Treatment)

    Time frame: From baseline to periprocedural

    Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms

  9. Proportion with Low Patient Global Impression of Change Scores (1 Month)

    Time frame: From baseline to 1 month follow-up

    Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms

  10. Proportion with Low Patient Global Impression of Change Scores (2 Months)

    Time frame: From baseline to 2 month follow-up

    Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms

  11. Proportion with Low Patient Global Impression of Change Scores (3 Months)

    Time frame: From baseline to 3 month follow-up

    Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms

  12. Related or Serious Adverse Events

    Time frame: From post-treatment to 1 week

    Incidence of related adverse events or serious adverse events

  13. New Stroke or All-Cause Death

    Time frame: From post-treatment to 1 month follow-up

    Incidence of new, disabling stroke or death from any cause

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Daniel A Tonetti, MD

Other

Collaborators

  • SNIS Foundation
  • Stryker Neurovascular

Registry information

Official study title

Localized Injection of Lidocaine Via the Middle Meningeal Artery for 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
Sep 22, 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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