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Preventive pharmacologic therapies for migraine aim to reduce attack frequency and duration and improve quality of life; however, their use, overall benefit and adherence are often limited. Remote electrical neuromodulation (REN) is a non-invasive FDA-cleared wearable device for acute and/or preventive migraine treatment. This study will evaluate the real-world efficacy and patient-reported outcomes of preventive REN use over 3 months in migraine patients.
Preventive treatment options for migraine aim to reduce attack frequency, severity, and duration, as well as the overall burden of disease, with the goal of improving patients' quality of life. The 2021 AHS Consensus Statement reports that preventive treatments are used by only 3%-13% of patients with migraine, despite the potential benefits for almost 40% of this population. Existing pharmacological treatments include several classes, such as beta-adrenergic blockers, calcium channel blockers, antiepileptic agents, tricyclic antidepressants, and therapies targeting the calcitonin gene-related peptide (CGRP) pathway, including monoclonal antibodies and small-molecule antagonists. Different studies have demonstrated that these agents can reduce monthly migraine days (MMDs) and migraine-related disability. However, their clinical use is often limited due to adverse effects, reduced effectiveness, contraindications, high cost, and poor long-term adherence, resulting in high discontinuation rates in real-world practice. These limitations highlight the need for effective, well-tolerated, and adherence-friendly preventive treatment alternatives.
Remote electrical neuromodulation (REN) is an FDA-cleared, non-invasive, non-pharmacologic prescribed wearable device indicated for the acute and/or preventive treatment of migraine in individuals aged 8 years and older. For acute treatment, REN is indicated for administration as early as possible at the onset of an attack to relieve pain and associated migraine symptoms. For preventive use, REN is indicated for treatment every other day to reduce migraine attack frequency.
The efficacy of REN for acute treatment of migraine attacks has been demonstrated in randomized controlled trials (RCTs), open-label studies, and many real-world evidence (RWE) studies. The efficacy of migraine prevention with the REN wearable has been also shown in an RCT. Preventive benefits were also shown in adolescents with high reduction in MMDs after 3 months of REN use. This study is the first to evaluate real-world preventive use of the REN wearable device in patients with migraine, assessing multiple efficacy and patient-reported outcomes following 3 months of treatment, in accordance with International Headache Society (IHS) guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerivio treatment | Active Comparator | Nerivio users who were prescribed with the REN wearable for their routine migraine care and treated in a prevention-like manner over 3 consecutive months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerivio REN device | Device | Remote electrical neuromodulation (REN) device for the acute treatment of migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average number of monthly migraine days (MMD) | Change in average number of monthly migraine days (MMD) from baseline to 3-months follow-up questionnaire. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients clinical improvement | Proportion of patients reporting improvement on PGIC scale at 3-months follow-up questionnaire. | 3 months |
| Change in migraine attack duration | Change in average migraine attack duration from baseline to 3-months follow-up questionnaire. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in acute migraine drug intake | Change in the percentage of treatments with acute migraine drug use. | 3 months |
| Reduction of >30% in all outcome measures (MMD, migraine attack duration, acute intake medication) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alit Stark Inbar | Theranica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theranica Bio-Electronics Inc | Bridgewater | New Jersey | 08807 | 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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Single Group Assignment Open label, single arm, Real-World-Evidence (RWE) study
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|
| 3 months |
| Device Safety | Rate of serious adverse events, adverse events and device-related adverse events | 3 months |
A clinically meaningful response, defined as the percentage of patients achieving a ≥30% reduction in MMDs, migraine attack duration, and acute drug use.
| 3 months |
| Change in migraine attack severity | Change in typical migraine attacks severity from baseline to 3-months follow-up questionnaire. | 3 months |
| D009422 | Nervous System Diseases |