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 |
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 |
| 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 |
| 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.
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Frequency
Duration
-How long the migraine headaches last in minutes
Location
Quality
Severity
- Migraine headache severity graded on a 0-10 scale, with 10 being the most severe.
Laterality
Associated symptoms
Exacerbating factors
Relieving factors
| 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 |
Inclusion Criteria:
Exclusion Criteria:
| 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 |
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| 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. |
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| 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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.
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| 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
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Withdrawn | ||||
| Actual Enrollment |
0 | ||||
| Original Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Brian Drolet, Vanderbilt University Medical Center | ||||
| Study Sponsor | Vanderbilt University Medical Center | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Vanderbilt University Medical Center | ||||
| Verification Date | January 2021 | ||||