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IRB submission never completed, study application withdrawn by IRB due to lack of response from PI
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The main goal of this study is to find out how well middle meningeal artery coil embolization works for patients with recurrent chronic migraines that are not resolved with medication.
This study seeks to evaluate the therapeutic potential of middle meningeal artery coil embolization as an interventional strategy for patients with recurrent and pharmacoresistant chronic migraine. Middle meningeal artery embolization has recently gained recognition as a safe and effective intervention for the management of chronic subdural hematoma, demonstrating a low complication profile. The procedure achieves therapeutic effect by reducing or occluding arterial flow within the middle meningeal artery, thereby minimizing arterial dilatation and facilitating hematoma resorption over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle Meningeal Artery Embolization | Experimental | Participants receive middle meningeal artery embolization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Middle Meningeal Artery Embolization | Procedure | Middle meningeal artery embolization using particles or coils |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migraine Disability Assessment (MIDAS) | The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache. | Baseline |
| Migraine Disability Assessment (MIDAS) | The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache. | 1 Hour Post Procedure |
| Migraine Disability Assessment (MIDAS) | The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache. | Day 15 Follow Up |
| Migraine Disability Assessment (MIDAS) | The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache. | Month 3 Follow Up |
| Migraine Disability Assessment (MIDAS) | The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache. | Month 6 Follow Up |
| Migraine Disability Assessment (MIDAS) | The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache. | Month 12 Follow Up |
| Migraine Pain Scale | Migraine pain scale range is 1-10 with a higher indicating severe level of pain. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pain Meds Used Post Procedure | Number of pain meds used by participant post embolization procedure | 1 Hour Post Procedure |
| Number of Pain Meds Used Post Procedure | Number of pain meds used by participant post embolization procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamad Farhat, MD | advocate christ medical center | Principal Investigator |
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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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| Migraine Pain Scale | Migraine pain scale range is 1-10 with a higher indicating severe level of pain. | 1 Hour Post Procedure |
| Migraine Pain Scale | Migraine pain scale range is 1-10 with a higher indicating severe level of pain. | Day 15 Follow Up |
| Migraine Pain Scale | Migraine pain scale range is 1-10 with a higher indicating severe level of pain. | Month 3 Follow Up |
| Migraine Pain Scale | Migraine pain scale range is 1-10 with a higher indicating severe level of pain. | Month 6 Follow Up |
| Migraine Pain Scale | Migraine pain scale range is 1-10 with a higher indicating severe level of pain. | Month 12 Follow Up |
| 6 Hours Post Procedure |
| Number of Pain Meds Used Post Procedure | Number of migraine pain meds used by participant post embolization procedure | Day 15 Follow Up |
| Number of Pain Meds Used Post Procedure | Number of migraine pain meds used by participant post embolization procedure | Month 3 Follow Up |
| Number of Pain Meds Used Post Procedure | Number of migraine pain meds used by participant post embolization procedure | Month 6 Follow Up |
| Number of Pain Meds Used Post Procedure | Number of migraine pain meds used by participant post embolization procedure | Month 12 Follow Up |
| D009422 | Nervous System Diseases |