Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
Part of paid clinical trials in Great Neck, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT07061847
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Lidocaine (drug) — DRUGThe 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.
- Lidocaine Procedure — PROCEDUREAll patient who meet eligibility criteria at their baseline visit will be scheduled for the Liocaine procedure.
Study Details
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 Dates
- Start date
- Mar 10, 2025
- Status verified
- May 2026
- Primary completion
- Mar 10, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: LidocaineAll patients who meet eligilibity criteria at their baseline visit will be scheduled for the Lidocaine procedure.
Primary Outcome Measure
Reduction in Monthly Migraine Headache Days [ Time Frame: From enrollment to post-treatment at 3 months ]
Central Contacts
- Jeffrey Katz, MD5163257000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Neuroscience Institute at Great Neck | Great Neck | New York | 11021 |
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