Understanding migraine pain mechanisms

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

This study is testing how certain medications that widen blood vessels can change migraine pain in people who haven't found relief with regular treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Montefiore Medical Center (other)
• Locations: 1 site (Bronx, New York)
• Trial ID: NCT03026101 on ClinicalTrials.gov

What this trial studies

This study aims to explore the underlying mechanisms of migraine pain by administering vasodilatory medications to specific branches of the external carotid artery and observing the resulting changes in headache pain and blood vessels. It will utilize advanced angiography techniques to correlate headache onset with vessel dilation, a novel approach that could enhance our understanding of migraines. Participants will be individuals who have not responded to standard migraine treatments and will undergo thorough evaluations and monitoring during the study.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with migraines who have not found relief from conventional treatments and experience severe, persistent symptoms.

Not a fit: Patients currently taking vasoactive drugs or those with significant underlying cardiac or pulmonary conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients suffering from debilitating migraines.

How similar studies have performed: While the approach of using angiography to study migraine pain is novel, similar studies have shown promise in understanding headache disorders.

Eligibility 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

Where this trial is running

Bronx, New York

• Montefiore Medical Center — Bronx, New York, United States (RECRUITING)

Study contacts

• Principal investigator: David J Altschul, MD — Montefiore Medical Center
• Study coordinator: David J Altschul, MD

Conditions: Migraine Disorders, Migraine, Classic, Migraine Without Aura