Understanding the Role of the External Carotid Artery in the Pathophysiology of Migraine Pain

Status: Terminated
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males. Emergency room visits, physician consults, hospitalizations, medications, and indirect costs such as lost work days and decreased productivity place the global economic burden of migraines at over 20 billion dollars. It is prevalent in 28 million people in the US alone. Symptoms include unilateral, throbbing, debilitating headache pain accompanied by nausea, vomiting, photophobia, and phonophobia. Upwards of 75% of migraine patients have reduced functionability, have lost time at work, and 1/3 of patients require bed rest to manage the symptoms. The health-related impact on quality of life was comparable with that experienced by patients with congestive heart failure, hypertension, or diabetes. While the burden of migraines on our society is clear, the pathophysiology of migraines remains largely unknown. The trigeminovascular system, including the external and internal carotid arteries and their associated sensory fibers which subserve the head have long been implicated in the pain and cutaneous allodynia experienced by migraine patients. Wolff in 1953, was the first to posit that migraine headache pain is the caused by dilation or circumferential expansion of the extracranial carotid artery. He demonstrated that migraineurs had twice the pulse amplitude in their external carotid arteries compared to control subjects and these changes were directly correlated to migraine symptoms. In a 2008 study, randomized migraineurs received nitroglycerin via peripheral IV or placebo for 20 minutes prior to obtaining magnetic resonance angiography (MRA). Nitroglycerin, a potent dilator of blood vessels, reliably induced migraine-like pain in up to 80% of patients, and transient dilation of vessels of up to nearly 40%, mostly in the extracranial vessels. Sumatriptan's efficacy in migraine relief provides further evidence for this theory, as it is a selective extracranial vessel constrictor which does not cross the blood brain barrier. The goal of this current work is to utilize the direct, real-time angiography, which provides a high resolution map of vasculature, and demonstrate changes in vessel flow in patients who have migraine headache attacks. This information may guide therapeutic interventions in the future in order to better treat these migraine patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• No changes to neurological exam within the preceding 6 months

• Requirement of a diagnostic cerebral angiogram for a previously treated aneurysm or arteriovenous malformation with no history of persistent disease

• A documented diagnosis of migraine made by a neurologist

• Migraines that are refractory to standard migraine pharmacologic treatment, with or without aura, either prophylactic or abortive, with persistent severe, debilitating symptoms

• Experience migraine symptoms at least twice a month

• Migraines symptomology which is discernible from other non-migraine headache pain

• Subjects must sign a consent form for both angiography and for participation in this study, and must be willing to undergo angiography for the evaluation of their symptoms

Locations
United States
New York
Montefiore Medical Center
The Bronx
Time Frame
Start Date: 2017-01
Completion Date: 2025-04-24
Participants
Target number of participants: 4
Treatments
Experimental: Migraine Intervention
A catheter will be placed in the symptomatic side external carotid artery and a diagnostic angiogram will be performed. The diameter of the occipital artery, superficial temporal artery and middle meningeal artery will be measured. Depending on the location of the headache superselective catheterization with microcatheter will be placed in either superficial temporal artery, occipital artery or middle meningeal artery. A volume of 50µg of nitroglycerin diluted in 10ml saline will be injected into the branch of interest dependent on laterality and location of symptoms over 30 seconds, to be delivered into these vessels only. 1 minute after superselective nitroglycerin injection the patient will be questioned as to whether the headache has been induced. A follow up diagnostic angiogram of the external carotid artery will be performed 3 minutes after injection. If there is no response to the lower 50µg, a dose of 150µg nitroglycerin in 10ml saline will be administered.
Sponsors
Leads: Montefiore Medical Center
Collaborators: Johns Hopkins University

This content was sourced from clinicaltrials.gov