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Investigator retierment
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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, Relievion™).
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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 |
|
| 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 |
|---|---|---|
| Pain Visual Analogue Scale (VAS) Change from basline to 1 hour | Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used) | 1 Hour |
| Measure | Description | Time Frame |
|---|---|---|
| Pain VAS change from baseline to 30 minutes | Mean change of pain score (measured on a visual analog scale) at 30 minutes compared to baseline (if rescue therapy was not used). | 30 minutes |
| Pain VAS change from baseline to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Klein, Dr | Meir Medical Center, Kfar Saba, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir General Hospital | Kfar Saba | Israel |
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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 on a visual analog scale) at 2 hours compared to baseline (if rescue therapy was not used).
| 2 Hours |
| Pain VAS change from baseline to 24 hours | Mean change of pain score (measured on a visual analog scale) at 24 hours compared to baseline (if rescue therapy was not used). | 24 Hours |
| Pain VAS change from baseline to 48 hours | Mean change of pain score (measured on a visual analog scale) at 48 hours compared to baseline (if rescue therapy was not used). | 48 Hours |
| Rescue medication at 2 hours | Proportion of patients not having required rescue medication at 2 hours | 2 hours |
| Rescue medication within 24 hours | Proportion of patients not having required rescue medication within 24 hours | 24 hours |
| Rescue medication within 48 hours | Proportion of patients not having required rescue medication within 48 hours | 48 hours |
| D009422 | Nervous System Diseases |