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出境医 / 临床实验 / Outcomes of Migraine Surgery

Outcomes of Migraine Surgery

Study Description
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.


Condition or disease Intervention/treatment
Migraine Procedure: 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.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Following Surgical Decompression for the Treatment of Migraine
Estimated Study Start Date : May 2020
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
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
Surgical decompression of neuromuscular structures causing migraine headaches.

Outcome Measures
Primary Outcome Measures :
  1. Change in International Classification of Headache Disorders Diagnostic criteria: Frequency [ Time Frame: 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

  2. Change in International Classification of Headache Disorders Diagnostic criteria: Duration [ Time Frame: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative ]

    Duration

    -How long the migraine headaches last in minutes


  3. Change in International Classification of Headache Disorders Diagnostic criteria: Location [ Time Frame: 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.

  4. Change in International Classification of Headache Disorders Diagnostic criteria: Quality [ Time Frame: 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.

  5. Change in International Classification of Headache Disorders Diagnostic criteria: Severity [ Time Frame: 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.


  6. Change in International Classification of Headache Disorders Diagnostic criteria: Laterality [ Time Frame: 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.

  7. Change in International Classification of Headache Disorders Diagnostic criteria: Associated Symptoms [ Time Frame: 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

  8. Change in International Classification of Headache Disorders Diagnostic criteria: Exacerbating factors [ Time Frame: 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)

  9. Change in International Classification of Headache Disorders Diagnostic criteria: Relieving factors [ Time Frame: 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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with migraine headaches that meet above inclusion/exclusion criteria
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
Contacts and Locations

Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Layout table for investigator information
Study Director: Salam Kassis, MD Vanderbilt University Medical Center
Tracking Information
First Submitted Date June 11, 2019
First Posted Date July 5, 2019
Last Update Posted Date January 14, 2021
Estimated Study Start Date May 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
  • Change in International Classification of Headache Disorders Diagnostic criteria: Frequency [ Time Frame: 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: Duration [ Time Frame: 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: Location [ Time Frame: 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: Quality [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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: Associated Symptoms [ Time Frame: 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
  • Change in International Classification of Headache Disorders Diagnostic criteria: Exacerbating factors [ Time Frame: 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: Relieving factors [ Time Frame: 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes of Migraine Surgery
Official Title Outcomes of Following Surgical Decompression for the Treatment of Migraine
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with migraine headaches that meet above inclusion/exclusion criteria
Condition Migraine
Intervention Procedure: Migraine surgery
Surgical decompression of neuromuscular structures causing migraine headaches.
Study Groups/Cohorts 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.

Intervention: Procedure: Migraine surgery
Publications *
  • 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.
  • 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.
  • 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.
  • 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. Review.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 9, 2021)
0
Original Estimated Enrollment
 (submitted: July 1, 2019)
100
Actual Study Completion Date June 1, 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04008303
Other Study ID Numbers 190993
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared
Responsible Party Brian Drolet, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Not Provided
Investigators
Study Director: Salam Kassis, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date January 2021