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Outcomes of Migraine Surgery

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ClinicalTrials.gov Identifier: NCT04008303
Recruitment Status : Withdrawn (No participants enrolled since this study open. The Primary research member (medical school student) is no longer available to do this study)
First Posted : July 5, 2019
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Brian Drolet, Vanderbilt University Medical Center

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

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.




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008303


Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Study Director: Salam Kassis, MD Vanderbilt University Medical Center
Publications of Results:
Other Publications:
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Responsible Party: Brian Drolet, Assistant Professor Department of Plastic Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04008303    
Other Study ID Numbers: 190993
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases