Outcomes of Migraine Surgery

Study Overview
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Brief Summary
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Migraines are very common and affect over 35 million Americans a year. Migraines can be painful and affect daily life. The cause of migraine is multifactorial and not completely understood. Treatment usually includes different classes of medications, life style changes, physical therapy, acupuncture, nerve stimulators and avoiding common triggers (like bright lights, certain foods, or loud sounds). For some patients, Botox injected into the muscles of the forehead and neck can significantly reduce pain. Unfortunately, this does not provide long-term relief as the effect of Botox lasts for 3 months. Since year 2000 surgery to treat a selected population of migraine patients has been gaining popularity and showing promising results. The surgery reduces the pressure on the peripheral nerves that are believed to cause migraine headaches by resecting the surrounding tissue (bone, fascia, muscle, and arteries). This surgery provides a more long-term and permanent relief. The purpose of this study is to follow the effectiveness and outcomes of migraine surgery.

Detailed Description
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Migraines are very common and affect over 35 million Americans a year. Migraines can be painful and affect daily life. The cause of migraine is multifactorial and not completely understood. Treatment usually includes different classes of medications, life style changes, physical therapy, acupuncture, nerve stimulators and avoiding common triggers (like bright lights, certain foods, or loud sounds). For some patients, Botox injected into the muscles of the forehead and neck can significantly reduce pain. Unfortunately, this does not provide long-term relief as the effect of Botox lasts for 3 months. Since year 2000 surgery to treat a selected population of migraine patients has been gaining popularity and showing promising results. The surgery reduces the pressure on the peripheral nerves that are believed to cause migraine headaches by resecting the surrounding tissue (bone, fascia, muscle, and arteries). This surgery provides a more long-term and permanent relief. The purpose of this study is to follow the effectiveness and outcomes of migraine surgery.

Official Title
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Outcomes of Following Surgical Decompression for the Treatment of Migraine

Conditions
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Migraine

Intervention / Treatment
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* Procedure: Migraine surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Cleared by neurology and headache specialists for surgery Patient cleared by neurology for not having medication overuse headaches Patient able to localize a consistent trigger site where the migraines start Patient has been suffering from migraine for more than 2 years Botox injections or nerve blocks have worked for migraine relief in the past Patients formally diagnosed with migraine headaches by a neurologist Migraines impact quality of life per MIDAS survey No history of Mania, Bipolar disorder, Major Dispersive disorder, or suicidal ideation Exclusion Criteria: High dose opioid medication use Does not meet criteria for migraine diagnosis History of prior surgery for migraines

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with migraines<br>Patients seen in clinic and assessed with Migraine Headache Diagnostic Criteria to ensure diagnosis. Patients track the characteristics of migraine headaches for one month before surgery. After this month, patients receive surgery in the operating room for migraine. After surgery, patients track the characteristics of migraine headaches for 3 months. Patients will then be asked to track the characteristics migraine headaches again at 1 year and 2 years and 5 years after surgery. For these time periods, patients only have to keep track of the characteristics for 1 month intervals. | Procedure: Migraine surgery<br>* Surgical decompression of neuromuscular structures causing migraine headaches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Classification of Headache Disorders Diagnostic criteria: Frequency | Frequency Number of migraine headaches per day Number of migraine headaches per week | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | 
| Change in International Classification of Headache Disorders Diagnostic criteria: Duration | Duration -How long the migraine headaches last in minutes | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | 
| Change in International Classification of Headache Disorders Diagnostic criteria: Location | Location Area of head that hurts with migraines. Options include front, side, top, and back. | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | 
| Change in International Classification of Headache Disorders Diagnostic criteria: Quality | Quality Description of the migraine pain. Options include sharp, stabbing, dull, pulsating, and burning. | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | 
| Change in International Classification of Headache Disorders Diagnostic criteria: Severity | Severity - Migraine headache severity graded on a 0-10 scale, with 10 being the most severe. | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | 
| Change in International Classification of Headache Disorders Diagnostic criteria: Laterality | Laterality Side of the head that is impacted with migraine headaches Options include right, left, or both. | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | 
| Change in International Classification of Headache Disorders Diagnostic criteria: Associated Symptoms | Associated symptoms Question to record associated symptoms that occur with migraine headaches Options include nausea, vomiting, photophobia, photophobia, and aura symptoms | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | 
| Change in International Classification of Headache Disorders Diagnostic criteria: Exacerbating factors | Exacerbating factors Open ended question to record anything that makes the migraine headaches worse. Examples include medications, environmental triggers (light, noise, etc), and lifestyle (stress, exercise, etc) | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | 
| Change in International Classification of Headache Disorders Diagnostic criteria: Relieving factors | Relieving factors Open ended question to record anything that makes the migraine headaches better. Examples include medications, avoidance of environmental triggers (light, noise, etc), and lifestyle changes (stress avoidance, exercise, etc) | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |