Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment (LIGHT 2)

January 21, 2026 updated by: Daniel A Tonetti, MD

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Health Care
        • Contact:
          • Cooper University Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Intra-arterial lidocaine
Drug: Lidocaine (drug)
Intra-arterial lidocaine infusion into bilateral middle meningeal arteries
Other Names:
  • Xylocaine
Sham Comparator: Sham
Intra-arterial saline
Drug: Saline
Intra-arterial saline infusion into bilateral middle meningeal arteries
Other Names:
  • Fluids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to 4 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel A Tonetti, MD

Investigators

  • Study Chair: Manisha Koneru, MD, The Cooper Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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