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1.
Adv Ther ; 41(1): 170-181, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37855973

RESUMO

INTRODUCTION: 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. This study examined long-term safety, utilization, and efficacy of REN during 12 consecutive usage months. METHODS: Data from patients with migraine across the USA using REN to treat their migraine attacks were electronically collected from the Nerivio® device. All patients who used REN during 12 consecutive months were included, and data were compared across months. Safety was assessed by the number and type of adverse events. Utilization was measured by the number of monthly treatments. Efficacy was evaluated as consistent change in headache pain intensity, functional disability, and disappearance of associated symptoms from baseline to 2 h post treatment. RESULTS: Data were analyzed from 409 people living with migraine who treated with REN for 12 consecutive months, performing a total of 39,531 treatments. The incidence of device-related adverse events (dAEs) was 1.96% (8/409), including two negligible (0.49%), five mild (1.22%), one moderate (0.24%), and no severe events. All patients continued treatment with REN despite dAEs. One-year average monthly utilization was 8.05 treatments (SD 1.15). Month-to-month utilization did not change during 12 months of consecutive use [F(4.895, 1997.204) = 2.014, p = 0.075, repeated-measures ANOVA]. One-year average efficacy showed 74.1% of users reported consistent 2-h pain relief, and 26.0% reported consistent pain freedom. Month-to-month pain relief and pain freedom did not change during 12 months of consecutive use [F(11, 1069) = 0.55, p = 0.873 and F(11, 1295) = 0.69, p = 0.750 respectively; generalized linear mixed model analysis]. CONCLUSION: REN is a safe and well-tolerated acute migraine treatment, with stable efficacy and utilization over 1 year, making it an advantageous non-drug option for the long-term management of this chronic disease. TRIAL REGISTRATION NUMBER: NCT05760638.


Migraine is a chronic disease leading to decades of significant disability, thus requiring safe, effective, and tolerable treatment for years. Remote electrical neuromodulation (REN) is a smartphone-controlled wearable device (Nerivio®) indicated for the acute and/or preventive treatment of migraine in patients 12 years of age or older. It is a prescribed, self-administered device for use at the onset of migraine headache or aura for acute treatment, or every-other-day for preventive treatment. Treatments are automatically registered in the REN app and database, and users can prospectively report subjective migraine indicators and response to the treatment in the REN app, at treatment onset and again 2 h later. This study analyzed data from people who used REN for the acute treatment of their migraine attacks at least once per month, for at least 12 consecutive months. Data from 409 patients who met the study criteria and performed a total of 39,531 treatments was analyzed. Safety was measured by the incidence of device-related adverse events, which was 1.96%. Severe device-related adverse events were not reported, and all patients continued treating after the events. Efficacy over the year showed that 74.1% of the patients reported consistent pain relief, and 26.0% reported consistent pain freedom. Average monthly utilization over the year was 8.05 treatments. Month-to-month pain relief, pain freedom, and utilization did not differ between 12 months of consecutive use. These results show that REN is a safe and well-tolerated treatment, with stable efficacy and utilization over at least 1 year, making it an advantageous non-drug option for the long-term management of migraine.


Assuntos
Transtornos de Enxaqueca , Humanos , Resultado do Tratamento , Método Duplo-Cego , Transtornos de Enxaqueca/tratamento farmacológico , Manejo da Dor , Cefaleia
2.
Front Pain Res (Lausanne) ; 4: 1247313, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38028429

RESUMO

Introduction: Migraine is a chronic neurological disease manifesting as attacks of disabling head pain and associated symptoms. Remote electrical neuromodulation (REN) is a non-pharmacological, prescribed, wearable device (Nerivio®). This device has been certified by the FDA for the acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. The device is affixed to the user's arm during 45-min treatment sessions and is operated using a smartphone app. This study (NCT05769322) aims to evaluate whether frequent use of REN for the acute treatment of migraine in adolescents resulted in a reduction in monthly migraine treatment days (MMTD), as previously demonstrated in adults through a dedicated prevention clinical trial (NCT04828707). Methods: The study included real-world prospective data from adolescent patients who used REN on at least 10 days every 28-day month, following the REN migraine prevention guideline of an every-other-day pattern. Additional requirements were at least three REN treatment days in each of the two subsequent months. The number of MMTD was used as a proxy measure for the number of monthly migraine days (MMD). The change in MMTD from the first month, taken as a "baseline," to each of the following months was used to evaluate the presence and size of potential migraine preventive benefits of REN in adolescents. Results: A total of 83 adolescents were eligible for analysis. The users were 15.9 ± 1.3 years of age (mean ± SD), and 89% of them were female. The results demonstrated a substantial month-to-month reduction in the mean (±SD) number of REN treatment days from 12.6 (±3.2) MMTD in the first month to 9.0 (±4.8) MMTD in the second month (p < 0.001), and a further decrease to 7.4 (±4.2) MMTD in the third month (p < 0.001). This indicates an accumulative reduction of 5.2 (±4.8) mean REN MMTD from the first month to the third month of consecutive REN treatment. The users also reported consistent 2-h acute pain responses in at least 50% of their treated attacks, with 61.9% of the users reported experiencing pain relief, 24.5% reported pain freedom, 67.4% indicated relief in functional disability, and 41.3% reported complete freedom from functional disability. Conclusion: The frequent use of REN among adolescents as an acute treatment for migraine attacks resulted in a decrease in the mean number of monthly treatment days in the subsequent months, suggesting that REN may have potential preventive benefits for migraine in this subpopulation.

3.
Pain Manag ; 13(8): 425-432, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37615080

RESUMO

Aim: To evaluate the onset, magnitude and persistence of efficacy of remote electrical neuromodulation (REN) compared with placebo for the preventive treatment of migraine. Materials & methods: 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. Results: Differences between the active (N = 95) and placebo (N = 84) groups reached significance at 2 weeks: therapeutic gain 0.84 MMD; p = 0.036. 4 weeks gain 1.59 MMD; p = 0.025, 6 weeks gain 2.27 MMD; p < 0.001, 8 weeks gain 2.68 MMD; p < 0.001. Conclusion: REN provides rapid and consistent efficacy in preventive treatment of migraine.

5.
J Med Econ ; 26(1): 656-664, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37083448

RESUMO

AIMS: 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. Therapeutic-gain was the between-groups difference (REN minus placebo) in change from baseline to the second month of intervention. Health-economics impact was derived as cost-savings associated with REN's clinical benefits. RESULTS: Out of 248 subjects randomized (128 active, 120 placebo), 179 (95:84) qualified for modified intention-to-treat (mITT) analysis. Significant therapeutic gains favoring REN vs. placebo were found (Tepper et al. 2023), including mean (±SD) reduction in number of acute medication days (3.5 ± 0.4 vs. 1.2 ± 0.5; gain = 2.2; p = .001) and presenteeism days (2.7 ± 0.3 vs. 1.1 ± 0.4; gain = 1.6, p = .001). Mean changes of provider visits (reduction of 0.09 ± 0.1 vs. increase of 0.08 ± 0.2; p = .297), and reduction of absenteeism days (0.07 ± 0.1 vs. 0.07 ± 0.2; p = .997) were not significant. Mean annual cost-saving for one patient using REN for migraine prevention estimated $10,000 (±$1,777) from reductions in these four clinical outcomes relative to baseline without REN treatment. Extrapolated to a hypothetical US commercial health-plan of one-million covered lives, assuming the national prevalence of migraine patients on preventive treatment, annual mean (±SE) cost-saving from using REN migraine prevention estimated $560.0 million (±$99.5 million) from reduction in direct (∼$330 millionm) and indirect costs (∼$230 millionm) measured. LIMITATIONS: Clinical and cost-savings benefits presented are conservative, assessed only from endpoints measured in the clinical trial. Moreover, some of the endpoints had only scarce or no occurrences during the study period. CONCLUSIONS: Coverage of the REN-device for migraine prevention may significantly reduce disease-burden and save a one-million-member payer plan at least $560 million per year.


Migraine affects more than 1 billion people worldwide, causing significant disability and substantial clinical economic burden. Remote Electrical Neuromodulation (REN) is a prescribed, wearable, non-pharmacological, non-invasive device (Nerivio), indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years and older. Efficacy of REN for migraine prevention was recently demonstrated in a randomized, blinded, placebo-controlled clinical-trial. This study further analyzes clinical benefits from endpoints measured in the clinical-trial as well as their associated direct and indirect costs. Out of 248 subjects randomized (128 active, 120 placebo), 179 (95:84) qualified for modified intention-to-treat (mITT) analysis. Significant therapeutic gains favoring REN over placebo were found, including an average reduction of 3.4 acute medication days/month, and an average reduction of 2.7 presenteeism days/month. A reduction in the number of provider visits and absenteeism days was also reported, though not significantly differed from changes in the control group. Mean annual cost-saving from reductions in these four clinical outcomes relative to baseline without REN treatment for a patient using REN for migraine prevention estimated $10,000. Extrapolated to a hypothetical US commercial health-plan of one million covered lives, annual mean cost-saving from using REN for migraine prevention is estimated to be $560.0 million, composed of $327.8 million direct costs and $232.2 million indirect costs. Thus, REN preventive treatment for migraine reduces disease burden and leads to meaningful cost-saving, both direct and indirect, proposing clinical and financial incentives for patients, health insurance systems, and employers to utilize REN for migraine prevention.


Assuntos
Transtornos de Enxaqueca , Humanos , Estudos Prospectivos , Efeitos Psicossociais da Doença , Método Duplo-Cego , Resultado do Tratamento
6.
Pediatr Neurol ; 142: 51-55, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36931109

RESUMO

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. This study evaluated real-world efficacy of REN in adolescents aged 12 to 17 years. Real-world data were collected from patients aged 12 to 17 years treated with the REN device (Nerivio) from January 1, 2021, to May 31, 2022. Study's end points included consistent efficacy two hours after treatment, use of REN as a standalone versus as an adjunct therapy, treatment intensity, and safety. Of 1629 adolescents included in the study, consistent response in at least 50% of treatments at two hours posttreatment was achieved by 60.3% of patients for pain relief, 26.3% for pain freedom, 66.3% for functional disability relief, and 41.2% for functional disability freedom. Of 2365 treatments in which medication usage was reported, REN was used as standalone therapy in 64.4% of the treatments, REN was combined with over-the-counter medications in 18.6%, and it was combined with prescription medications in 17%. Mean treatment intensity from 13,716 treatments was 28.5% (±13.6%) of the max stimulator output. Only three device-related adverse events were reported, all minor. This real-world analysis demonstrates the persistent efficacy of REN for abortive treatment of migraine in adolescents, extending findings of prior clinical trials in adolescents and real-world studies in adults.


Assuntos
Transtornos de Enxaqueca , Adolescente , Criança , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Estados Unidos
7.
Headache ; 63(3): 377-389, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36704988

RESUMO

OBJECTIVE: 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. METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled, multi-center trial, with 1:1 ratio. The study consisted of a 4-week baseline observation phase, and an 8-week double-blind intervention phase in which participants used either REN or a placebo stimulation every other day. Throughout the study, participants reported their symptoms daily, via an electronic diary. RESULTS: Two hundred forty-eight participants were randomized (128 active, 120 placebo), of which 179 qualified for the modified intention-to-treat (mITT) analysis (95 active; 84 placebo). REN was superior to placebo in the primary endpoint, change in mean number of migraine days per month from baseline, with mean reduction of 4.0 ± SD of 4.0 days (1.3 ± 4.0 in placebo, therapeutic gain = 2.7 [confidence interval -3.9 to -1.5], p < 0.001). The significance was maintained when analyzing the episodic (-3.2 ± 3.4 vs. -1.0 ± 3.6, p = 0.003) and chronic (-4.7 ± 4.4 vs. -1.6 ± 4.4, p = 0.001) migraine subgroups separately. REN was also superior to placebo in reduction of moderate/severe headache days (3.8 ± 3.9 vs. 2.2 ± 3.6, p = 0.005), reduction of headache days of all severities (4.5 ± 4.1 vs. 1.8 ± 4.6, p < 0.001), percentage of patients achieving 50% reduction in moderate/severe headache days (51.6% [49/95] vs. 35.7% [30/84], p = 0.033), and reduction in days of acute medication intake (3.5 ± 4.1 vs. 1.4 ± 4.3, p = 0.001). Similar results were obtained in the ITT analysis. No serious device-related adverse events were reported in any group. CONCLUSION: Applied every other day, REN is effective and safe for the prevention of migraine.


Assuntos
Transtornos de Enxaqueca , Humanos , Estudos Prospectivos , Transtornos de Enxaqueca/prevenção & controle , Transtornos de Enxaqueca/tratamento farmacológico , Resultado do Tratamento , Cefaleia , Método Duplo-Cego
8.
Pain Manag ; 12(7): 837-844, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36097974

RESUMO

Aim: 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. Materials & methods: Post-hoc 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. Results: No statistical differences were found between REN and the tested medications, in any of the effectiveness outcomes: single-treatment pain relief p = 0.056, single-treatment pain freedom p = 0.532, consistency of pain relief p = 0.369, consistency of pain freedom p = 1.00. Conclusion: The results suggest that REN may provide an effective non-pharmacological alternative for standard care abortive medications in individuals impacted by chronic migraine.


Due to the high frequency of headaches, patients impacted by chronic migraine are struggling with poor quality of life, as well as elevated risk of medication overuse headache (which might cause migraine chronification). Thus, there is a need for non-pharmacological migraine treatments that are both effective and well tolerated. Remote electrical neuromodulation (REN) is a non-pharmacological abortive migraine treatment, which is US FDA cleared for adults and adolescents with episodic or chronic migraine. The current study compared the effectiveness of REN to that of standard-care medications (i.e., over-the-counter medications and triptans), using data from 78 individuals with chronic migraine who participated in a clinical trial. During the study, each participant treated their attacks with their preferred medication for the first 4 weeks, and then treated their attacks with REN (only) for the following four weeks. The participants rated their pain level prior to each treatment, and 2 h after the beginning of the treatment. The results indicate no statistical difference between the effectiveness of REN and standard care medications and suggest that REN may provide an effective non-pharmacological alternative for standard care abortive medications, for individuals with chronic migraine.


Assuntos
Transtornos de Enxaqueca , Adulto , Método Duplo-Cego , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Manejo da Dor/métodos , Assistência ao Paciente , Resultado do Tratamento
9.
Pain Manag ; 12(3): 267-281, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34538078

RESUMO

Nerivio® (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. This review summarizes a series of five independent clinical trials and two real-world evidence studies that established safety, tolerability and efficacy of Nerivio in treating migraine attacks. It further provides up-to-date practical information on device usability. Based on findings of this review, Nerivio offers a safe and effective nonpharmacological alternative for acute treatment in patients with chronic (and nonchronic) migraine.


Nerivio® is a Bluetooth-enabled device controlled via smartphones for the treatment of migraine attacks. The device is placed on the arm and kept in place with an armband, delivering nonpainful electrical stimulation which in turn activates signals in the brain to release substances that help break pain. The device is cleared by the US FDA in the USA for the acute treatment of migraine in people 12 years or older with episodic or chronic migraine. This review provides a summary of several clinical trials and real-world evidence studies that helped show the safety, tolerability and efficacy of Nerivio as a migraine treatment. Based on these findings, Nerivio can offer a safe, well tolerated nonmedication option for patients with migraine.


Assuntos
Terapia por Estimulação Elétrica , Transtornos de Enxaqueca , Consenso , Cefaleia , Humanos , Transtornos de Enxaqueca/terapia , Manejo da Dor , Resultado do Tratamento
10.
Front Neurol ; 11: 567413, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33117262

RESUMO

Objective: To 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. Methods: 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. Different questionnaires exploring non-motor symptoms and quality of life were administered through phone-calls. Patients were asked to run the app at least twice per week (i.e., full compliance). Subjects were phone-checked weekly throughout a 3-week period for compliance and final satisfaction questionnaires. Results: Forty-five patients (83.3%) ran the app at least once; Twenty-nine (53.7%) subjects were half-compliant, while 16 (29.6%) were fully compliant. Adherence was hindered by technical issues or digital illiteracy (38.7%), demotivation (24%) and health-related issues (7.4%). Ten patients (18.5%) underwent PD therapy changes. The main factors related to lack of compliance included loss of interest, sadness, anxiety, the absence of a caregiver, the presence of falls and higher H&Y. Gait, tapping, tremor and cognitive application outcomes were correlated to disease duration, UPDRS-III and H&Y. Discussion: The majority of patients were compliant and satisfied by the provided monitoring program. Some of the application outcomes were statistically correlated to clinical parameters, but further validation is required. Our pilot study suggested that the available technologies could be readily implemented even with the current population's technical and intellectual resources.

11.
Sensors (Basel) ; 19(23)2019 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-31779224

RESUMO

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. Here we present an extended app, EncephaLogTM, which provides gait analysis in much more detail, offering 9 additional gait biomarkers on top of the TUG completion-time. In this pilot, four healthy adults participated in a total of 32 TUG tests; simultaneously recorded by EncephaLog and motion sensor devices used in movement labs: motion capture cameras (MCC), pressure mat; and/or wearable sensors. Results show high agreement between EncephaLog biomarkers and those measured by the other devices. These preliminary results suggest that EncephaLog can provide an accurate, yet simpler, instrumented TUG (iTUG) platform than existing alternatives, offering a solution for clinics that cannot afford the cost or space required for a dedicated motion lab and for monitoring patients at their homes. Further research on a larger study population with pathologies is required to assess full validity.


Assuntos
Análise da Marcha/instrumentação , Marcha/fisiologia , Monitorização Fisiológica/instrumentação , Acidentes por Quedas/prevenção & controle , Adulto , Feminino , Humanos , Masculino , Movimento/fisiologia , Projetos Piloto , Smartphone
12.
Psychiatry Res ; 275: 143-148, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30908978

RESUMO

Cognitive 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. Fifty adult participants completed standardized mood-related questionnaires, a novel immediate mood scale questionnaire (IMS-12), and a novel task, Emotion Matcher, in which they were required to indicate whether pairs of emotional faces show the same expression or not. We found that overall success rate and reaction time on the Emotion Matcher task did not differ as a function of severity of depression. However, more depressed participants had significantly worse performance when presented with sad-neutral face pairs, as well as increased reaction times to happy-happy pairs. In addition, accuracy of the sad-neutral pairs was found to be significantly associated with depression severity in a regression model. Our study provides partial support for the mood-congruent hypothesis, revealing only a potential bias in interpretation of sad and neutral expressions, but not a general deficit in processing of facial expressions. The potential of such bias in serving as a predictor for depression should be further examined in future studies.


Assuntos
Depressão/psicologia , Expressão Facial , Adulto , Afeto , Viés , Cognição , Transtorno Depressivo Maior/psicologia , Emoções , Feminino , Felicidade , Humanos , Masculino , Pessoa de Meia-Idade , Tempo de Reação , Adulto Jovem
13.
Hum Brain Mapp ; 38(12): 5970-5986, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-28885740

RESUMO

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. We present cumulative evidence supporting preferential encoding of kinematic parameters along the motor system, based on blood-oxygenation-level dependent signal recorded in a well-controlled single-joint wrist-flexion task. Whereas activity in the left primary motor cortex (M1) showed preferential encoding of movement amplitude, the anterior lobe of the right cerebellum (primarily lobule V) showed preferential encoding of movement speed. Conversely, activity in the left supplementary motor area (SMA), basal ganglia (putamen), and anterior intraparietal sulcus was not preferentially modulated by any specific parameter. We found no preference in peak activation for duration encoding in any of the tested regions. Electromyographic data was mainly modulated by movement amplitude, restricting the distinction between amplitude and muscle force encoding. Together, these results suggest that during single-joint movements, distinct kinematic parameters are controlled by largely distinct brain-regions that work together to produce and control precise movements. Hum Brain Mapp 38:5970-5986, 2017. © 2017 Wiley Periodicals, Inc.


Assuntos
Cerebelo/fisiologia , Córtex Motor/fisiologia , Movimento/fisiologia , Adulto , Fenômenos Biomecânicos , Mapeamento Encefálico , Cerebelo/diagnóstico por imagem , Circulação Cerebrovascular/fisiologia , Eletromiografia , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Córtex Motor/diagnóstico por imagem , Músculo Esquelético/fisiologia , Oxigênio/sangue , Punho/fisiologia , Adulto Jovem
14.
JMIR Mhealth Uhealth ; 5(4): e44, 2017 Apr 12.
Artigo em Inglês | MEDLINE | ID: mdl-28404542

RESUMO

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. Such mood assessment may help circumvent problems associated with infrequent reporting and better characterize the dynamic presentation of mood symptoms, informing the delivery of novel treatment options. OBJECTIVES: The aim of our study was to validate the Immediate Mood Scaler (IMS), a newly developed, iPad-deliverable 22-item self-report tool designed to capture current mood states. METHODS: A total of 110 individuals completed standardized questionnaires (Patient Health Questionnaire, 9-item [PHQ-9]; generalized anxiety disorder, 7-Item [GAD-7]; and rumination scale) and IMS at baseline. Of the total, 56 completed at least one additional session of IMS, and 17 completed one additional administration of PHQ-9 and GAD-7. We conducted exploratory Principal Axis Factor Analysis to assess dimensionality of IMS, and computed zero-order correlations to investigate associations between IMS and standardized scales. Linear Mixed Model (LMM) was used to assess IMS stability across time and to test predictability of PHQ-9 and GAD-7 score by IMS. RESULTS: Strong correlations were found between standard mood scales and the IMS at baseline (r=.57-.59, P<.001). A factor analysis revealed a 12-item IMS ("IMS-12") with two factors: a "depression" factor and an "anxiety" factor. IMS-12 depression subscale was more strongly correlated with PHQ-9 than with GAD-7 (z=1.88, P=.03), but the reverse pattern was not found for IMS-12 anxiety subscale. IMS-12 showed less stability over time compared with PHQ-9 and GAD-7 (.65 vs .91), potentially reflecting more sensitivity to mood dynamics. In addition, IMS-12 ratings indicated that individuals with mild to moderate depression had greater mood fluctuations compared with individuals with severe depression (.42 vs .79; P=.04). Finally, IMS-12 significantly contributed to the prediction of subsequent PHQ-9 (beta=1.03, P=.02) and GAD-7 scores (beta =.93, P=.01). CONCLUSIONS: Collectively, these data suggest that the 12-item IMS (IMS-12) is a valid tool to assess momentary mood symptoms related to anxiety and depression. Although IMS-12 shows good correlation with standardized scales, it further captures mood fluctuations better and significantly adds to the prediction of the scales. Results are discussed in the context of providing continuous symptom quantification that may inform novel treatment options and support personalized treatment plans.

15.
J Neurophysiol ; 117(1): 412-428, 2017 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-27832611

RESUMO

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. Participants were tested twice on a visuomotor adaptation task and on a sequence learning task, either the serial reaction time task or the alternating reaction time task. Learning was evident in all tasks at the group level and reliable at the individual level in visuomotor adaptation and the alternating reaction time task but not in the serial reaction time task. Performance variability was predictive of learning in both domains, yet the relationship was in the opposite direction for adaptation and sequence learning. For the former, faster learning was associated with lower variability, consistent with models of sensorimotor adaptation in which learning rates are sensitive to noise. For the latter, greater learning was associated with higher variability and slower reaction times, factors that may facilitate the spread of activation required to form predictive, sequential associations. Interestingly, learning measures of the different tasks were not correlated. Together, these results oppose a shared process for implicit learning in sensorimotor adaptation and sequence learning and provide insight into the factors that account for individual differences in learning within each task domain. NEW & NOTEWORTHY: We investigated individual differences in the ability to implicitly learn motor skills. As a prerequisite, we assessed whether individual differences were reliable across test sessions. We found that two commonly used tasks of implicit learning, visuomotor adaptation and the alternating serial reaction time task, exhibited good test-retest reliability in measures of learning and performance. However, the learning measures did not correlate between the two tasks, arguing against a shared process for implicit motor learning.


Assuntos
Adaptação Fisiológica/fisiologia , Individualidade , Destreza Motora/fisiologia , Movimento/fisiologia , Aprendizagem Seriada/fisiologia , Adolescente , Feminino , Humanos , Masculino , Estimulação Luminosa , Tempo de Reação/fisiologia , Adulto Jovem
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