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This is a Post-marketing, real-world evidence study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura.
Safety will be assessed by the number and type of device-related adverse events. Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment. Disease characteristics will look into demographic and attack differences between patients with and without aura.
The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 12 years old and above. It is a wearable device applied to the upper arm.
As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specify that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secured, personal migraine diary, which enables patients to record and track their migraines and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including the presence or absence of aura, pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), presence of associated symptoms (photophobia, phonophobia, and nausea), and an indication of which medications, if any, were taken within that 2-hour time window.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in patients with and without aura by analyzing data from patients who used the Nerivio device. The following outcomes will be assessed:
Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine with or without aura.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Migraine with aura (MWA) | Patients with migraine who treated their migraine attack with the Nerivio device at least twice and reported having aura in at least two treatment reports |
| |
| Migraine without aura (MWoA ) | Patients with migraine who treated their migraine attack with the Nerivio device at least twice and reported the absence of aura in all of their reports, with at least two reports |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerivio device | Device | REN treatment with Nerivio device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of consistent Headache Relief at 2 Hours Post-treatment between the MWA and MWoA groups | The difference between the MWA and MWoA groups in the proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments. Headache relief is defined as an improvement from severe or moderate pain to mild or no pain. | 2 hours |
| Comparison of Headache Severity at treatment baseline (T=0h) between the MWA and MWoA groups | The difference between the MWA and MWoA groups in the proportion of subjects reporting severe/moderate headache pain in at least 50% of their attacks. | 0 hours (at baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of consistent Pain Freedom at 2 Hours Post-treatment between the MWA and MWoA groups | The difference between the MWA and MWoA groups in the proportion of subjects reporting pain freedom at 2 hours post-treatment in at least 50% of all their treatments. Pain freedom is defined as the disappearance of pain from severe, moderate, or mild at treatment initiation to no pain 2 hours later. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were diagnosed with migraine by their HCP and were prescribed Nerivio for treatment of acute migraine
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| Name | Affiliation | Role |
|---|---|---|
| Alit Stark Inbar, PhD | Theranica Bio-Electronics Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theranica Bio-Electronics Ltd | Netanya | 4520438 | Israel |
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D008881 | Migraine Disorders |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Comparison of Functional Disability at treatment baseline (T=0h) between the MWA and MWoA groups | The difference between the MWA and MWoA groups in the proportion of subjects reporting severe/moderate disability in at least 50% of their attacks. | 0 hours (at baseline) |
| Comparison of Photophobia, Phonophobia and Nausea/vomiting presence at treatment baseline (T=0h) between the MWA and MWoA groups | The difference between the MWA and MWoA groups in the proportion of subjects reporting presence of a specific symptom in at least 50% of their attacks. | 0 hours (at baseline) |
| Comparison of Consistent Functional Disability Relief at 2 Hours Post-treatment between the MWA and MWoA groups | The difference between the MWA and MWoA groups in the proportion of subjects reporting functional disability relief at 2 hours post-treatment in at least 50% of all their treatments. Functional disability relief is defined as an improvement of at least one grade from severe, moderate or mild disability from treatment initiation to 2 hours later. | 2 hours |
| Comparison of Consistent Functional Disability Freedom at 2 Hours Post-treatment between the MWA and MWoA groups | The difference between the MWA and MWoA groups in the proportion of subjects reporting functional disability freedom at 2 hours post-treatment in at least 50% of all their treatments. Functional disability freedom is defined as the disappearance of disability from severe, moderate, or mild disability at treatment initiation to no disability 2 hours later. | 2 hours |
| Comparison of Associated Symptoms Freedom at 2 Hours Post-treatment between the MWA and MWoA groups | The proportion of subjects reporting freedom from each of the migraine-associated symptoms (photophobia, phonophobia, nausea) in at least 50% of their treatments. Associated symptoms freedom is defined as reporting presence of a symptom at treatment initiation and reporting its absence 2 hours later. | 2 hours |
| Device Related Adverse Events | Rate of serious adverse events, and device-related adverse events reported by subjects. | up to 30 months |
| D009422 | Nervous System Diseases |