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This study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievionâ„¢).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relievion device- Treatment stimulation | Active Comparator | Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation |
|
| Sham Comparator: Relievion device- Sham Stimulation | Sham Comparator | Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relievion device- Treatment stimulation | Device | 1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used). | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable painbaseline (if rescue therapy was not used). | 2 hours |
| Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints will consist of recording of adverse events and serious adverse events during the study. Device related adverse events will be evaluated between study groups | Safety endpoints will consist of recording of adverse events and serious adverse events during the study. Device related adverse events will be evaluated between study groups | 1, 2, 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Dr. Oved, Dr. | Laniado Medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laniado Medcial Center | Netanya | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35661128 | Derived | Daniel O, Tepper SJ, Deutsch L, Sharon R. External Concurrent Occipital and Trigeminal Neurostimulation Relieves Migraine Headache: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial. Pain Ther. 2022 Sep;11(3):907-922. doi: 10.1007/s40122-022-00394-w. Epub 2022 Jun 4. |
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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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|
| Relievion Device- Sham stimulation | Device | 1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation |
|
|
Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used). |
| 24 hours |
| Proportion of patients not having required rescue medication within 24 hours | Proportion of patients not having required rescue medication within 24 hours | 24 hours |
| Proportion of patients not having required rescue medication at 2 hours compared to baseline. | Proportion of patients not having required rescue medication at 2 hours | 2 hours |
| Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used). | Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used). | 1, 2, 24 hours |
| Proportion of "responders" ("responder" is defined as decrease of at least 50% in VAS pain score from baseline) at 1,2 and 24 hours from baseline (if rescue therapy was not used). | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain | 1, 2, 24 hours |
| D009422 | Nervous System Diseases |