NCT07061847

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Given the current literature and using intent-to-treat clinical judgement, the research team believes that the treatment offered in this study may offer a promising benefit to treatment resistant migraine patients. Despite modest advances in drug therapy, some patients still suffer from chronic migraines. Therefore, the headache medicine community continues to search for alternative treatments in the form of research. The research team is conducting a prospective observational study to gather data before and after this treatment is administered to determine whether there is improvement in migraine duration, intensity, and frequency. 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. This is NOT the first time this procedure has been performed. Intra-arterial lidocaine infusion has been used safely during the treatment of other brain diseases. Infusing brain vessels with lidocaine is not new technique. The treatment offered in this study is new for the treatment of migraines. This particular treatment has been performed successfully in the small group studies that the study investigators are modeling after. The investigative neuro-interventionists have been rigorously trained for this approach and hold a minimum of double board certifications. This team is experienced in using these techniques for other brain diseases and have successfully performed this specific procedure in a select group of early patients. Collectively, the team holds over 45+ years of experience in performing neuro-endovascular procedures. During the intra-arterial infusion of lidocaine for treatment of a subdural procedure, an incidental finding noted that patients had reduced headache intensity following this treatment. Therefore, this technique has been re-purposed in this study to treat chronic migraine sufferers. The procedure is considered investigational because lidocaine is not yet FDA-approved for this specific use. Although several studies have demonstrated that this approach is a safe and tolerable treatment for chronic migraine, there is still insufficient evidence to incorporate it into the current day standard of care protocol. Ultimately, the purpose of this study is to explore this approach to and determine if this treatment can induce a significant improvement in chronic migraine, intensity, duration, and frequency.

Conditions

• Migraine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2027-03-10
• Completion: 2027-06-30
• First posted: 2025-07-11
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study