Treatment Patterns Among US Veterans Using Remote Electrical Neuromodulation (REN) for Migraine Treatment
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full 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 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- VA patiets who were prescribed withthe Nerivio REN device
- Performed REN treatments and reported baseline and 2-hours questionnaires at least twice
Exclusion criteria
- None
Trial design
Primary purpose
Allocation
Interventional model
Masking
600 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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