Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
Northwell Health
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.
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 mig…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH). 1. Chronic: as defined by the International Headache Society Classification ICHD 3 (\>15 headache days a month for a period of at least 3 months) 2. Medically refractory: defined as failure of ≥3 headache preventative treatments. 3. Severely disabling (Migraine Disability Assessment \[MIDAS\] Tool score of ≥ 21 \[Grade IV\]) 4. Score of 6 (very severe) or 7 (extremely severe) on the Global Assessment of Migraine Severity (GAMS) rating scale.…
Interventions
- DrugLidocaine (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.
- ProcedureLidocaine Procedure
All patient who meet eligibility criteria at their baseline visit will be scheduled for the Liocaine procedure.
Location
- Neuroscience Institute at Great NeckGreat Neck, New York