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COVID-19 impact
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Patients with migraine often report that stressors such as skipping a meal can bring on a migraine whereas some patients report that their migraine improves with food. Few studies to date have looked at the relationship between blood glucose (sugar) and migraine. We are conducting this study to better understand whether or not changes in blood glucose levels can trigger migraine or provide relief during a migraine attack.
The purpose of this pilot and feasibility study is to assess if changes in blood glucose both trigger migraine and can provide analgesia. This information will provide a vital basis for the mechanism of migraine and offer insights into better treatments as well as prevention.
This is a pilot unblinded randomized trial with two independent components, Aims 1 and 2. It is not possible to blind the current protocol both in terms of the blood sugar readings and the luna bar, non-luna bar intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luna Bar Intervention | Experimental | Participants will be asked to monitor their blood sugar during migraine. Study data will also include blood glucose levels, pain severity, 24-hour food diary, 24-hour exercise diary, duration of sleep, perception of quality of sleep, and last menstrual period. This information will be recorded at times when a Luna bar is not consumed, and at times when a Luna Bar is consumed. Participants will serve as their own controls. |
|
| Morning Migraine | No Intervention | Participants will be asked to monitor their blood sugar on headache free days as well as during migraine. This arm is only for participants who identify as having morning migraine. Study data will also include blood glucose levels, pain severity, 24-hour food diary, 24-hour exercise diary, duration of sleep, perception of quality of sleep, and last menstrual period. Participants will serve as their own controls. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luna Bar | Other | Luna Bar (blueberry bliss or lemon zest flavor) product of Clif |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in blood glucose on days with migraine compared to blood glucose on days without migraine | The primary endpoint will be the difference in blood glucose on days with migraine compared to blood glucose on days without migraine using repeated measure ANOVA | Change Measure: migraine days and non-migraine days over 3 month period. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the change in pain score from the time of pain plateau to the pain score at 120 minutes as measured by a visual analogue scale. | The primary outcome is the change in pain score from the time the patients pain plateaus (as measured by having a stable pain score for 60 minutes) compared to the pain score at 120 minutes using a repeated measures ANOVA. We will compare these measures on migraine days with Luna and without Luna bar (control days) using a repeated measures ANOVA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Hovaguimian, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medial Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Change Measure: migraine days and non-migraine days over 3 month period. |
| D009422 | Nervous System Diseases |