Outcomes of Migraine Surgery

Withdrawn

• Conditions: Migraine
• Interventions: Procedure: Migraine surgery

• Registration Number: NCT04008303
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Study Start: 2020-05
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• High dose opioid medication use
• Does not meet criteria for migraine diagnosis
• History of prior surgery for migraines

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with migraines	Migraine surgery	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.

Primary Outcome Measures

Name	Time	Method
Change in International Classification of Headache Disorders Diagnostic criteria: Frequency	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	Frequency; * Number of migraine headaches per day; * Number of migraine headaches per week
Change in International Classification of Headache Disorders Diagnostic criteria: Location	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	Location; * Area of head that hurts with migraines.; * Options include front, side, top, and back.
Change in International Classification of Headache Disorders Diagnostic criteria: Exacerbating factors	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	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)
Change in International Classification of Headache Disorders Diagnostic criteria: Duration	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	Duration; -How long the migraine headaches last in minutes
Change in International Classification of Headache Disorders Diagnostic criteria: Quality	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	Quality; * Description of the migraine pain.; * Options include sharp, stabbing, dull, pulsating, and burning.
Change in International Classification of Headache Disorders Diagnostic criteria: Severity	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	Severity; - Migraine headache severity graded on a 0-10 scale, with 10 being the most severe.
Change in International Classification of Headache Disorders Diagnostic criteria: Laterality	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	Laterality; * Side of the head that is impacted with migraine headaches; * Options include right, left, or both.
Change in International Classification of Headache Disorders Diagnostic criteria: Relieving factors	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	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)
Change in International Classification of Headache Disorders Diagnostic criteria: Associated Symptoms	1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative	Associated symptoms; * Question to record associated symptoms that occur with migraine headaches; * Options include nausea, vomiting, photophobia, photophobia, and aura symptoms