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) — 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.
  • Lidocaine Procedure — PROCEDURE
    All 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: Lidocaine
    All 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

Locations (1)

FacilityCityStateZIPSite coordinators
Neuroscience Institute at Great NeckGreat NeckNew York11021
Nicholas Zumba
516-473-5807

Find similar trials in Great Neck, NY

By condition
By specialty

Related Studies