Acute Treatment of Migraine, Migraine
Conditions
Keywords
Nerivio, Remote Electrical Neuromodulation, Acute Treatment of Migraine
Brief summary
Among US veterans, migraine is a prevalent and disabling neurological disorder, creating a clinical need for effective treatment options. This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatment of migraine among veterans, with a primary focus on whether they need rescue medications following REN treatment. Findings from this study may help guide clinical decision-making as veterans and providers craft treatment plans that include non-pharmacologic options.
Detailed description
Migraine is a highly prevalent and disabling neurological disorder characterized by recurrent headache attacks often accompanied by nausea, sensitivity to light or sound, and functional impairment. Affecting approximately 14% of the global population, migraine substantially reduces quality of life and interferes with daily functioning. Within the veteran affairs (VA) population in the United States, headache disorders including migraine, are particularly common, and their diagnosis has increased throughout the years. In this population, headache disorders commonly develop following service-related injuries or exposures, such as service eras and traumatic brain injury (TBI), contributing their prevalence and severity. Moreover, veterans with headache disorders frequently present with multiple comorbidities, including post-traumatic stress disorder (PTSD), depression, anxiety, sleep disorders, chronic musculoskeletal pain, neck and back disorders, and TBI-related symptoms. This complex clinical profile increases disability, complicates treatment decisions, and can limit the use of certain pharmacologic therapies due to contraindications or polypharmacy. Despite the availability of multiple therapeutic options, many patients face challenges in managing their migraine due to limited drug tolerability, contraindications, or medication-overuse headache (MOH). These challenges are particularly pronounced among veterans where comorbid conditions and polypharmacy often complicate or restrict pharmacological therapeutic options highlighting the need for effective, well-tolerated, non-pharmacological alternatives. Demonstrating effective pain, functional impairment, and symptom freedom or relief, with minimal reliance on additional medications, is particularly relevant in this population. This need is supported by the adoption of non-pharmacological treatment options by the Veterans Health Administration (VHA). Remote electrical neuromodulation (REN) is a prescribed wearable device for non-invasive, non-pharmacological treatment of migraine, indicated for acute and/or preventive treatment in patients aged 8 years and older. Many studies, including randomized controlled trials and real-world evidence studies, have shown the efficacy and safety of the REN wearable device in treating migraine pain and associated symptoms. This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatments of migraine among veterans, with a primary focus on whether they need rescue medications following REN treatment, as well as on treatment effectiveness.
Interventions
DEVICENerivio REN device
Remote electrical neuromodulation (REN) wearable 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.
Sponsors
Theranica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open label, single arm, real-world-evidence (RWE) study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* VA patients who were prescribed the Nerivio REN device * Performed at least 2 REN treatments with both baseline and 2-hours reports
Exclusion criteria
• None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Medication Usage | 2 hours | Proportion of treatments in which patients did not use additional prescribed medications within 2-hours following REN treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief | 2 hours | Proportion of treatments in which there was a reduction in headache intensity from moderate or severe headache at baseline to mild or no pain 2 hours post-treatment. |
| Pain Freedom | 2 hours | Proportion of treatments in which there was a reduction in headache intensity from mild or moderate or severe headache at baseline to no headache 2 hours post-treatment. |
| Functional Disability Relief | 2 hours | Proportion of treatments in which there was at least one-grade improvement in functional disability level at baseline to 2 hours post-treatment. |
| Functional Disability Freedom | 2 hours | Proportion of treatments in which there was a reduction in functional disability level at baseline to no functional disability at 2 hours post-treatment. |
| Freedom from migraine-associated symptoms (Photophobia, Phonophobia, Nausea/Vomiting) | 2 hours | Proportion of treatments in which there was an absence of at least one of the three associated symptoms 2 hours post-treatment in treatments with reported associated symptoms at baseline. |
| Treatment intensity | 45 minutes | Average treatment intensity across all treatments per patient and cohort |
| Device Safety | up to 5 years | Rate of serious adverse events, adverse events, and device-related adverse events |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlit Stark-Inbar, PhD
Theranica
Outcome results
None listed