Outcomes of Migraine Surgery

Migraine Clinical Trial

Official title:

Outcomes of Following Surgical Decompression for the Treatment of Migraine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04008303
• Other study ID #: 190993
• Status: Withdrawn
• Start date: May 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: January 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Procedure:
• Migraine surgery
Surgical decompression of neuromuscular structures causing migraine headaches.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

References & Publications (10)

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. Review. — View Citation

Guyuron B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005 Jan;115(1):1-9. — View 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):603-8. doi: 10.1097/PRS.0b013e3181fed456. — View 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):461-8. doi: 10.1097/PRS.0b013e3181adcf6a. — View 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. — View 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-41S. doi: 10.1097/PRS.0000000000000661. — View 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):751-7. doi: 10.1097/PRS.0b013e3182818b7f. — View 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. Epub 2005 Dec 15. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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