Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1 (LIGHT 1)

Intra-Arterial Injection of Lidocaine and Glucocorticoid in the Treatment of Intractable Headaches: A Non-Randomized, Open-Label Phase 1 Clinical Trial

The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines).

The main questions this study aims to answer: is this treatment safe for chronic migraine patients?

Participants will:

• Be treated once with lidocaine and steroid infused into the middle meningeal arteries (two blood vessels in the brain).
• Attend appointments scheduled 1 week, 6 weeks, and 12 weeks after the treatment for a checkup.
• Keep a log of their symptoms.

Study Overview

• Status: Completed
• Conditions: Refractory Migraine
• Intervention / Treatment: Drug: Lidocaine hydrochloride; Drug: Methylprednisolone sodium succinate

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female greater than or equal to 18 years of age.
• Documentation of a diagnosis of intractable migraine without aura, including failure of at least four classes of preventative drugs. Either intolerance or side effects requiring discontinuation or adequate trial at therapeutic dose without relief constitutes failure of therapy.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

• Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants, or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
• 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.
• Patients with concomitant intracranial pathology (e.g., intracranial malignancy).
• Blood glucose level on screening complete metabolic blood panel > 400 mg/dL.
• Patients with known hypersensitivity and/or contraindication to either lidocaine hydrochloride or methylprednisolone sodium succinate, including:
• Patients with known history of hypersensitivity to local anesthetics of the amide type.
• Patients with systemic fungal infections.
• Patients with known or suspected hypersensitivity to cow's milk or its components or other dairy products (SOLU-MEDROL® 40mg presentation includes lactose monohydrate, and may contain trace amounts of milk ingredients).
• Patients 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.
• Patients taking chronic medications that, when co-administered with methylprednisolone, are at increased risk for hypokalemia, altered drug levels, convulsions, or altered clearance: amphotericin B, diuretics, aminoglutethimide, macrolide antibiotics, anticholinesterases, antitubercular drugs, cholestyramine, cyclosporine, digitalis glycosides, estrogens (including oral contraceptives), hepatic enzyme inducers/inhibitors, and ketoconazole.
• Patients have known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.
• Patient has known active systemic infection or sepsis.
• Patient has contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC).
• Concurrent participation in another research protocol for investigation of an experimental therapy.
• Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the Investigator or treating provider.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Cohort; Intra-arterial 80mg lidocaine and 40mg methylprednisolone	Drug: Lidocaine hydrochloride; Intra-arterial injection of 40mg lidocaine per middle meningeal artery (total 2 arteries) administered one time; Other Names: lidocaine; Xylocaine-MPF; Drug: Methylprednisolone sodium succinate; Intra-arterial injection of 20mg methylprednisolone per middle meningeal artery (total 2 arteries) administered one time; Other Names: methylprednisolone; SOLU-MEDROL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event	From treatment to 12-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event	From screening enrollment to the end of study follow-up at 12 weeks

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Collaborators: Society of Vascular and Interventional Neurology
• Investigators: Principal Investigator: Daniel A Tonetti, MD, The Cooper Health System; Study Chair: Manisha Koneru, MD, The Cooper Health System; Study Chair: Hamza A Shaikh, MD, The Cooper Health System

Publications and helpful links

General Publications

• Koneru M, Shaikh HA, Khalife J, Syrow L, Santucci J, Ballout AA, Patel PD, Thomas AJ, Jovin TG, Tonetti DA. Localized Injection of Lidocaine and Glucocorticoid for Refractory Headache Treatment (LIGHT): A Phase 1 Clinical Trial for Safety. Stroke: Vascular and Interventional Neurology. 2025 Oct 29. https://doi.org/10.1161/SVIN.125.001966

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Actual): May 13, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: November 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: lidocaine; headache; migraine; glucocorticoid; intra-arterial; middle meningeal artery; status migrainosus
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache; Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Prednisolone; Lidocaine; Methylprednisolone; Methylprednisolone Hemisuccinate
• Other Study ID Numbers: 23-267

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No