Study Results
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Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-05-31
2020-06-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with migraines
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.
Migraine surgery
Surgical decompression of neuromuscular structures causing migraine headaches.
Interventions
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Migraine surgery
Surgical decompression of neuromuscular structures causing migraine headaches.
Eligibility Criteria
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Inclusion Criteria
* 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
* Does not meet criteria for migraine diagnosis
* History of prior surgery for migraines
18 Years
ALL
Yes
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Brian Drolet
Assistant Professor Department of Plastic Surgery
Principal Investigators
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Salam Kassis, MD
Role: STUDY_DIRECTOR
Vanderbilt University Medical Center
References
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Negro A, Rocchietti-March M, Fiorillo M, Martelletti P. Chronic migraine: current concepts and ongoing treatments. Eur Rev Med Pharmacol Sci. 2011 Dec;15(12):1401-20.
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.
Stewart WF, Simon D, Shechter A, Lipton RB. Population variation in migraine prevalence: a meta-analysis. J Clin Epidemiol. 1995 Feb;48(2):269-80. doi: 10.1016/0895-4356(94)00128-d.
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.
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.
Gfrerer L, Guyuron B. Surgical treatment of migraine headaches. Acta Neurol Belg. 2017 Mar;117(1):27-32. doi: 10.1007/s13760-016-0731-1. Epub 2016 Dec 24.
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.
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.
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.
Guyuron B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005 Jan;115(1):1-9.
Other Identifiers
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190993
Identifier Type: -
Identifier Source: org_study_id
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