Outcomes of Migraine Surgery

January 12, 2021 updated by: Brian Drolet, Vanderbilt University Medical Center

Outcomes of Following Surgical Decompression for the Treatment of Migraine

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with migraine headaches that meet above inclusion/exclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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.
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
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.
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
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.
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
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.
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
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
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
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)
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
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)
1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Study Director: Salam Kassis, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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