MigraineNCT04008303
Outcomes of Migraine Surgery
An observational study of Migraine, run by Vanderbilt University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Migraine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with migraine headaches that meet above inclusion/exclusion criteria
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- High dose opioid medication use
- Does not meet criteria for migraine diagnosis
- History of prior surgery for migraines
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Migraine surgery
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Migraine surgeryProcedure or surgery
Surgical decompression of neuromuscular structures causing migraine headaches.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Migraine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Classification of Headache Disorders Diagnostic criteria: Frequency
Frequency
- Number of migraine headaches per day
- Number of migraine headaches per week
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startMay 2020 (estimated)
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Why it stopped: No participants enrolled since this study open. The Primary research member (medical school student) is no longer available to do this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Drolet, Vanderbilt University Medical Center
- Investigators
- Salam Kassis, MD, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008303
- Sponsor's protocol ID
- 190993
- Status last verified
- Jan 2021
- First submitted
- 11 Jun 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
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.
PubMed 22288302Janis 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.
PubMed 25254996Stewart 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.
PubMed 7869073Leonardi 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.
PubMed 16388337Guyuron 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.
PubMed 20966820Gfrerer 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.
PubMed 28013487Guyuron 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.
PubMed 19644260Guyuron 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.
PubMed 10946944Lee 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.
PubMed 23542247Guyuron B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005 Jan;115(1):1-9.
PubMed 15622223
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Following Surgical Decompression for the Treatment of Migraine
- ClinicalTrials.gov ID
- NCT04008303
- Acronym / sponsor ID
- 190993
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled since this study open. The Primary research member (medical school student) is no longer available to do this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with migraines | – | Procedure: Migraine surgeryPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with migraine headaches that meet above inclusion/exclusion criteria
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- High dose opioid medication use
- Does not meet criteria for migraine diagnosis
- History of prior surgery for migraines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Migraine surgerySurgical decompression of neuromuscular structures causing migraine headaches. | Procedure or surgery | Patients with migraines |
Primary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 22288302Negro 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.
- Background: PubMed 25254996Janis 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.
- Background: PubMed 7869073Stewart 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.
- Background: PubMed 16388337Leonardi 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.
- Background: PubMed 20966820Guyuron 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.
- Background: PubMed 28013487Gfrerer 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.
- Background: PubMed 19644260Guyuron 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.
- Results publication: PubMed 10946944Guyuron 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.
- Results publication: PubMed 23542247Lee 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.
- Results publication: PubMed 15622223Guyuron B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005 Jan;115(1):1-9.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salam Kassis, MD study director
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04008303, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.