Clinical trial NCT04008303: Outcomes of Migraine Surgery
Official title: Outcomes of Following Surgical Decompression for the Treatment of Migraine
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Migraine
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with migraine headaches that meet above inclusion/exclusion criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Frequency
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Duration
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Location
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Quality
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Severity
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Laterality
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Associated Symptoms
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Exacerbating factors
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
measure: Change in International Classification of Headache Disorders Diagnostic criteria: Relieving factors
timeFrame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Salam Kassis, MD
role: STUDY_DIRECTOR
References:
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citation: Janis JE, Barker JC, Javadi C, Ducic I, Hagan R, Guyuron B. A review of current evidence in the surgical treatment of migraine headaches. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):131S-141S. doi: 10.1097/PRS.0000000000000661.
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citation: Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring disability in headache disorders with WHO's Classification of Functioning, Disability and Health (ICF). J Headache Pain. 2005 Dec;6(6):429-40. doi: 10.1007/s10194-005-0252-4. Epub 2005 Dec 15.
citation: Guyuron B, Kriegler JS, Davis J, Amini SB. Five-year outcome of surgical treatment of migraine headaches. Plast Reconstr Surg. 2011 Feb;127(2):603-608. doi: 10.1097/PRS.0b013e3181fed456.
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citation: Guyuron B, Reed D, Kriegler JS, Davis J, Pashmini N, Amini S. A placebo-controlled surgical trial of the treatment of migraine headaches. Plast Reconstr Surg. 2009 Aug;124(2):461-468. doi: 10.1097/PRS.0b013e3181adcf6a.
citation: Guyuron B, Varghai A, Michelow BJ, Thomas T, Davis J. Corrugator supercilii muscle resection and migraine headaches. Plast Reconstr Surg. 2000 Aug;106(2):429-34; discussion 435-7. doi: 10.1097/00006534-200008000-00030.
citation: Lee M, Monson MA, Liu MT, Reed D, Guyuron B. Positive botulinum toxin type a response is a prognosticator for migraine surgery success. Plast Reconstr Surg. 2013 Apr;131(4):751-757. doi: 10.1097/PRS.0b013e3182818b7f.
citation: Guyuron B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005 Jan;115(1):1-9.