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 among veterans with migraine, 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
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 impairmen. 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, headach disorders are particularly common, and their diagnosis has increased throughout the years. Veterans headaches mostly include both migraine and post-traumatic headache (PTH). PTH commonly develops 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 commonly 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, the risk of medication-overuse headache (MOH), or polypharmacy. These challenges are particularly pronounced among veterans where comorbid conditions and polypharmacy often complicate or restrict therapeutic options highlighting the need for effective, well-tolerated, non-pharmacological alternatives. Demonstrating effective pain, functional impairment and symptom relief or freedom 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 have shown the efficacy and safety of the REN wearable device in treating migraine pain and associated symptoms. Given that many PTH cases present with migraine-like characteristics, VA providers may prescribe the REN wearable for PTH with migraine-like symptoms. This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable among veterans with migraine, with a primary focus on whether they need rescue medications following REN treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Remote electrical neuromodulation (REN) device for the acute treatment of migraines. 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
Theranica Bio-Electronics Inc
Bridgewater, New Jersey, United States
Rescue Medication Usage
Proportion of treatments in which patients did not use additional prescribed medications within 2-hours following REN treatment
Time frame: 2 hours
Pain Relief
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.
Time frame: 2 hours
Pain Freedom
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.
Time frame: 2 hours
Functional Disability Relief
Proportion of treatments in which there was at least one-grade improvement in functional disability level at baseline to 2 hours post-treatment.
Time frame: 2 hours
Functional Disability Freedom
Proportion of treatments in which there was a reduction in functional disability level at baseline to no functioal disability at 2 hours post-treatment.
Time frame: 2 hours
Freedom from each migraine-associated symptom (Photophobia, Phonophobia, Nausea/Vomiting)
Proportion of treatments in which there was an absence of each of the three associated symptoms 2 hours post-treatment in treatments with reported associated symptoms at baseline
Time frame: 2 hours
Treatment intensity
Average treatment intensity across all treatments per patient and cohort
Time frame: 45 minutes
Device Safety
Rate of serious adverse events, adverse events and device-related adverse events
Time frame: up to 5 years
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