Headache, Refractory Migraine
Conditions
Keywords
headache, migraine, lidocaine, middle meningeal artery
Brief summary
The goal of this clinical trial is to test whether injecting lidocaine into two blood vessels of the brain can help treat chronic headaches (migraines)
Interventions
DRUGLidocaine (drug)
Intra-arterial lidocaine infusion into bilateral middle meningeal arteries
DRUGSaline
Intra-arterial saline infusion into bilateral middle meningeal arteries
Sponsors
Daniel A Tonetti, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or above * Referred for diagnostic angiography * Diagnosis of intractable migraine * Written informed consent able to be obtained from subject
Exclusion criteria
* Baseline HIT-6 score less than 60 (severe) * Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data * Concomitant intracranial pathology (eg, intracranial malignancy) * Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type * Taking chronic medications that, when co-administered with lidocaine and other local anesthetics, are at increased risk of developing methemoglobinemia (nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, acetaminophen, metoclopramide, quinine, sulfasalazine) * Known contraindications for angiography (eg, ESRD not requiring hemodialysis). Patients with contrast allergy with be premeditated with diphenhydramine and steroids. * Contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC) * Concurrent participation in another research protocol for investigation of an experimental therapy * Per DSA imaging, presence of a cerebrovascular pathology known to cause headache (eg, arteriovenous malformation, dural arteriovenous fistula) * Per DSA imaging, presence of anastomosis or anatomical variation (eg, branches of middle meningeal artery) that could lead to increased procedural risk * Per DSA imaging, lack of endovascular access to either middle meningeal artery, or origin of the middle meningeal artery other than from the external carotid artery * Known or suspected inability to adhere to study protocol or protocol requirements, as per discretion of the Investigator or treating provider
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Headache Impact Test-6 Scores | From baseline to 4 week follow-up | Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms |
Countries
United States
Contacts
STUDY_CHAIRManisha Koneru, MD
The Cooper Health System
Outcome results
None listed