Outcomes of Migraine Surgery

NCT04008303 | Withdrawn

• 1 other identifier: 190993
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

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.

Procedure: Migraine surgery

Interventions

Migraine surgery PROCEDURE

Surgical decompression of neuromuscular structures causing migraine headaches.

Patients with migraines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with migraine headaches that meet above inclusion/exclusion criteria

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Related Publications (10)

• 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.

  PMID: 22288302 BACKGROUND

• 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.

  PMID: 25254996 BACKGROUND

• 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.

  PMID: 7869073 BACKGROUND

• 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.

  PMID: 16388337 BACKGROUND

• 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.

  PMID: 20966820 BACKGROUND

• 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.

  PMID: 28013487 BACKGROUND

• 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.

  PMID: 19644260 BACKGROUND

• 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.

  PMID: 10946944 RESULT

• 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.

  PMID: 23542247 RESULT

• Guyuron B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005 Jan;115(1):1-9.

  PMID: 15622223 RESULT

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Salam Kassis, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Plastic Surgery

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: July 5, 2019
• Study Start: May 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share