Actively Recruiting
Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
Led by Northwell Health · Updated on 2025-07-16
40
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years with very severe to extremely severe medically refractory chronic daily headache
- Chronic daily headache defined as more than 15 headache days per month for at least 3 months
- Failure of three or more headache preventative treatments
- Severe disability with Migraine Disability Assessment Tool score of 21 or higher (Grade IV)
- Very severe or extremely severe migraine severity score of 6 or 7 on Global Assessment of Migraine Severity scale
- Head pain intensity of more than 5 on a Visual Analog Scale for at least 50% of headaches
- Diagnosis of chronic daily headache for 12 months or more before screening
- Minimum of 15 monthly headache days on average across the 3 months prior to screening
- Reported intolerance or insufficient response to current preventive treatment after at least 6 weeks on a therapeutic dose
- Stable concomitant medication and headache preventive treatment for 3 months prior to screening
- At least 75% compliance with headache diary during baseline period
- Must continue to meet eligibility at baseline completion visit
You will not qualify if you...
- Started new migraine preventative treatment within the past 3 months
- Known allergy or sensitivity to lidocaine
- Use of Lidoderm patch within 3 days before procedure
- Severe allergy or anaphylaxis to iodinated contrast dye
- Any intracranial pathology on brain imaging within past 12 months
- Chronic subdural hematoma
- Ischemic stroke or myocardial infarction within past 3 months
- History of renal insufficiency with creatinine over 1.5 within past 3 months
- History of abnormal ECGs within past 3 months including prolonged QT syndrome
- Use of medications that may prolong QT interval
- Taking any antiarrhythmic medication other than beta blockers
- Symptomatic peripheral arterial disease
- Known inherited or acquired bleeding disorders except antiplatelet or anticoagulation medication
- Active substance-related or addictive disorders within 12 months
- Active chronic pain syndromes like fibromyalgia or chronic pelvic pain
- History of major psychiatric disorder or severe depression (PHQ-9 score 15 or higher)
- Pregnant, planning pregnancy, or planning to make partner pregnant without proper contraception
- Any diagnosis deemed by investigator to make patient unfit for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Neuroscience Institute at Great Neck
Great Neck, New York, United States, 11021
Actively Recruiting
Research Team
J
Jeffrey Katz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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