Understanding the Pathophysiology of Migraine Pain

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 20
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Nitroglycerin
• Last Updated: 2017-08-28

Criteria

Inclusion Criteria:

• Subjects with a documented diagnosis of migraine by a neurologist

• Subjects refractory to standard migraine therapy with persistent severe, debilitating symptoms

• Subjects without changes to their neurological exam within the preceding 6 months

• Migraines at least twice a month

• Migraines unique and distinguishable 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

Exclusion Criteria:

• Subjects taking vasoactive drugs including epinephrine, norepinephrine, dopamine, dobutamine, isoprenaline, dopexamine, milrinone, amrinon, levosimendan, glucagon, phenylephrine, metaraminol, ephedrine, vasopressin, digoxin, and levothyroxine

• Subjects with underlying cardiac pathology including but not limited to coronary artery disease, heart attacks, or severe atherosclerosis,

• Subjects with severe pulmonary disease requiring supplemental oxygen therapy

• Subjects taking medications similar to nitroglycerin such as phosphodiesterase inhibitors

• Subjects with contraindications to nitroglycerin or calcium channel blocker use

• Subjects who have had coffee, tea, or alcohol in the 12 hours before the start of the angiogram

• Subjects having other headache conditions or pain syndromes

• Subjects with prior intracranial therapies or craniotomies for management of any intracranial lesions

• Subjects in whom the angiography demonstrates severe vessel tortuosity or stenosis, vasospasm not responsive to medical therapy, or abnormal communication between intracranial and extracranial vessels either in the past or during the study procedure

• Subjects who are not able to reliably report symptoms

• Subjects who do not consent to participate

• Subjects who are pregnant and children