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RECRUITING
NCT07061847
PHASE2

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the effectiveness of a new treatment in improving chronic migraine symptoms. This treatment involves a targeted lidocaine infusion into blood vessels in the skull to numb pain receptors, potentially leading to improvements in chronic migraine intensity, frequency, and duration.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-03-10

Completion Date

2027-06-30

Last Updated

2025-07-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

Lidocaine (drug)

The study intervention involves the use of 1% cardiac preservative-free lidocaine. Lidocaine is a local anesthetic commonly used in medical procedures to numb a specific area of the body. In this case, the lidocaine is formulated at a concentration of 1% and will be diluted to 50 mL with normal saline. This treatment is an intra-arterial bilateral lidocaine infusion into the middle meningeal artery (i.e. this is a lidocaine infusion into the brain blood vessels to turn off the pain receptors responsible for causing chronic headaches). Lidocaine is an FDA approved anesthetic (i.e. pain killer) used in common medical practice. Lidocaine, however, has not yet been approved by the FDA for this particular use. For this reason, the use of lidocaine in this study is considered investigational.

PROCEDURE

Lidocaine Procedure

All patient who meet eligibility criteria at their baseline visit will be scheduled for the Liocaine procedure.

Locations (1)

Neuroscience Institute at Great Neck

Great Neck, New York, United States