Objective: Migraine affects millions of individuals in the US, resulting in high health care costs and productivity loss. Traditional medications are often limited in effectiveness and tolerability, creating a need for accessible nonpharmacologic options. This coverage with evidence development (CED) study assessed the necessity of the remote electrical neuromodulation (REN) wearable device for migraine treatment as a standard payer-covered treatment.
View Article and Find Full Text PDFMigraine affects 10% of adolescents and children. Typical school protocols in the USA require pharmacological medications to be administered by school nurses, often resulting in treatment delays or omissions when migraine attacks occur during school hours. The Remote Electrical Neuromodulation (REN) wearable is an FDA-cleared smartphone-controlled device delivering acute and preventive treatment of migraine attacks in patients aged 8 and above, allowing safe, effective, discreet, and independent usage.
View Article and Find Full Text PDFIntroduction: Migraine is a chronic neurological disorder causing severe pain and disability in more than a billion people worldwide. Ideal treatment should provide long-term efficacy with minimal side effects. Previous studies indicate that remote electrical neuromodulation (REN) is an efficacious and safe treatment option for the acute treatment of migraine in clinical practice.
View Article and Find Full Text PDFTo evaluate the onset, magnitude and persistence of efficacy of remote electrical neuromodulation (REN) compared with placebo for the preventive treatment of migraine. Analysis was conducted on data from a prospective, double-blind, placebo-controlled clinical trial, which assessed the efficacy of REN for the prevention of migraine. The number of monthly migraine days (MMD) per group was calculated in 2-week intervals and compared between the groups.
View Article and Find Full Text PDFAims: Assess the clinical benefits and associated direct and indirect cost-savings from Remote Electrical Neuromodulation (REN) for migraine prevention.
Methods: REN, a prescribed, wearable, FDA-cleared neuromodulation-device for acute and/or preventive treatment of migraine, recently demonstrated efficacy for migraine prevention when used every-other-day, in a prospective, randomized, double-blind, placebo-controlled, multi-center study. Following baseline (4-weeks), subjects underwent treatment with REN or placebo (8-weeks), and electronically reported migraine symptoms and acute treatments daily.
Nearly 10% of children and adolescents in the United States experience migraine. Pharmacologic treatment of migraine in adolescents is limited due to only few US Food and Drug Administration (FDA)-approved medications, limited efficacy, or lack of tolerability. Remote Electrical Neuromodulation (REN) is a nonpharmacologic abortive treatment for migraine, cleared by the FDA for patients aged 12 years and above.
View Article and Find Full Text PDFObjective: To assess the clinical efficacy of remote electrical neuromodulation (REN), used every other day, for the prevention of migraine.
Background: Preventive treatment is key to managing migraine, but it is often underutilized. REN, a non-pharmacological acute treatment for migraine, was evaluated as a method of migraine prevention in patients with episodic and chronic migraine.
The current study compared the effectiveness of remote electrical neuromodulation (REN) to that of standard-care medications for acute treatments of migraine, using a within-subjects design. within-subject analysis was performed on data from 78 adult chronic migraine patients who participated in a clinical trial with REN, on four end points: single-treatment pain relief, single-treatment pain freedom, consistency of pain relief and consistency of pain freedom. No statistical differences were found between REN and the tested medications, in any of the effectiveness outcomes: single-treatment pain relief p = 0.
View Article and Find Full Text PDFNerivio (by Theranica Bio-Electronics Ltd, Tel Aviv, Israel) is a wireless, wearable, noninvasive, battery-operated, remote electrical neuromodulation device controlled by a smartphone application. It is US FDA authorized for the acute treatment of migraine with or without aura in people 12 years and older in the US, and European Conformity (CE) marked for the same indication in the EU. The American Headache Society Consensus Statement recommends Nerivio as a tier 2 treatment for migraines.
View Article and Find Full Text PDFTo evaluate the feasibility of a smartphone remote patient monitoring approach in a real-life Parkinson's disease (PD) cohort during the Italian COVID-19 lockdown. Fifty-four non-demented PD patients who were supposed to attend the outpatient March clinic were recruited for a prospective study. All patients had a known UPDRS-III and a modified Hoehn and Yahr (H&Y) score and were provided with a smartphone application capable of providing indicators of gait, tapping, tremor, memory and executive functions.
View Article and Find Full Text PDFSensors (Basel)
November 2019
Gait disorders and falls are common in elders and in many clinical conditions, yet they are typically infrequently and subjectively evaluated, limiting prevention and intervention. Completion-time of the Timed-Up-and-Go (TUG) test is a well-accepted clinical biomarker for rating mobility and prediction of falls risk. Using smartphones' integral accelerometers and gyroscopes, we already demonstrated that TUG completion-time can be accurately measured via a smartphone app.
View Article and Find Full Text PDFCognitive models of depression suggest that depressed individuals exhibit a tendency to attribute negative meaning to neutral stimuli, and enhanced processing of mood-congruent stimuli. However, evidence thus far has been inconsistent. In this study, we sought to identify both differential interpretation of neutral information as well as emotion processing biases associated with depression.
View Article and Find Full Text PDFHum Brain Mapp
December 2017
Voluntary movements require control of multiple kinematic parameters, a task carried out by a distributed brain architecture. However, it remains unclear whether regions along the motor system encode single, or rather a mixture of, kinematic parameters during action execution. Here, rapid event-related functional magnetic resonance imaging was used to differentiate brain activity along the motor system during the encoding of movement amplitude, duration, and speed.
View Article and Find Full Text PDFJMIR Mhealth Uhealth
April 2017
Background: Mood disorders are dynamic disorders characterized by multimodal symptoms. Clinical assessment of symptoms is currently limited to relatively sparse, routine clinic visits, requiring retrospective recollection of symptoms present in the weeks preceding the visit. Novel advances in mobile tools now support ecological momentary assessment of mood, conducted frequently using mobile devices, outside the clinical setting.
View Article and Find Full Text PDFUnlabelled: In standard taxonomies, motor skills are typically treated as representative of implicit or procedural memory. We examined two emblematic tasks of implicit motor learning, sensorimotor adaptation and sequence learning, asking whether individual differences in learning are correlated between these tasks, as well as how individual differences within each task are related to different performance variables. As a prerequisite, it was essential to establish the reliability of learning measures for each task.
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