RESUMEN
MANDAT: L'Institut national d'excellence en santé et en services sociaux (INESSS) a reçu le mandat du Bureau de l'innovation d'estimer la valeur de la technologie OptuneMC et la pertinence de sa couverture par le régime public en tant que dispositif de traitement des patients adultes souffrant d'un glioblastome nouvellement diagnostiqué avec et après la chimiothérapie d'entretien standard au témozolomide. DESCRIPTION: Pour l'indication demandée, le dispositif requiert la pose de matrices de transducteurs fixées sur le crâne rasé des patients afin de délivrer un champ électrique alternatif antitumoral via le générateur de champ OptuneMC. Les champs antitumoraux visent à stopper la progression des tumeurs en ciblant les étapes de la mitose des cellules cancéreuses et ils doivent agir en continu. Le dispositif OptuneMC est donc proposé avec des accessoires permettant un traitement ambulatoire et constant des patients. DÉMARCHE D'ÉVALUATION: Une revue des donn
MANDATE: L'Institut national d'excellence en santé et en services sociaux (INESSS) was mandated by the Bureau de l'innovation to assess the value of OptuneTM technology and the relevance of its coverage by the public plan as a treatment device for adult patients with newly diagnosed glioblastoma with and after standard temozolomide maintenance chemotherapy. DESCRIPTION: For the requested indication, the device requires the placement of transducer arrays to patients' shaved scalp to deliver to deliver a tumour-treating field through the OptuneTM field generator. Tumour treating fields aim to halt tumour progression by targeting the mitosis stages of cancer cells and must act continuously. The OptuneTM device is therefore provided with accessories for constant ambulatory treatment of patients. EVALUATION PROCESS: A review of data from the literature and those provided by the manufacturer was carried out to assess the scientific evidence regarding the application of tumour treating fields provided by Novocure's OptuneTM device for the treatment of newly diagnosed glioblastoma. Contextual and experiential stakeholder data were also collected through an expert advisory committee and one-on-one interviews with caregivers and patients who have used the OptuneTM device. SOCIO-CULTURAL DIMENSION: Despite the media visibility of the OptuneTM device and the enthusiasm for new therapeutic options, the acceptability of the device by Quebec patients is difficult to predict, as several factors need to be taken into consideration - e.g., aesthetic considerations, portability of the device and usage requirements. According to advisory committee members, the maximum acceptability rate could be as high as 50% of eligible patients offered the treatment. Some health technology assessment agencies have assessed OptuneTM and issued divergent recommendations, some favourable from the Haute Autorité de Santé (HAS, France), other unfavourable from the National Institute for Health and Care Excellence (NICE, UK). For their part, publications by listed oncology learned societies have chosen to recommend the OptuneTM device as a complementary treatment option to temozolomide in patients under 70 years of age. POPULATION DIMENSION: Glioblastoma is a heterogeneous cancer, with some subtypes more aggressive than others, affecting an estimated 150 new patient/year in Quebec. Median survival is around 8 months, with a 1-year survival rate of 25%. The disease is both cognitively and physically disabling, and family caregivers play an important role in its management. Current management is mainly based on diagnosis with magnetic resonance imaging (MRI), followed by tumour resection, when possible, combined radiotherapy with temozolomide, and maintenance chemotherapy with temozolomide (Stupp protocol). Despite treatment, 90% of patients will experience a recurrence of their cancer within 7 months. At this stage, there is no recognized standard of care. Glioblastoma is therefore an incurable pathology with limited treatment options, and with high unmet medical needs related to the development of new treatment options to prolong life and reduce the risk of recurrence. CLINICAL DIMENSION: The efficacy of the OptuneTM device is supported by the EF-14 study, an open-label, multicenter, randomized Phase 3 clinical trial conducted in 14 countries, including Canada. This study compared the efficacy of the OptuneTM device / temozolomide combination versus temozolomide alone in adult patients with supratentorial glioblastoma. The EF-14 study is judged to be of good methodological quality, despite the presence of a selection bias favouring the inclusion of individuals with a better prognosis. Moreover, the study population is also younger, has a higher performance index and contains a higher proportion of individuals with MGMT (6-O-Methylguanine-DNA methyltransferase) promoter methylation than the Quebec glioblastoma patient population. The main results of the study showed clinically significant gains in progression-free survival of 2.7 months and overall survival of 4.9 months. A dose-response effect was also observed according to patients' level of adherence to treatment, with a minimum use threshold of 50% to obtain a benefit, i.e., 12 hours per day. Secondary analyses failed to identify a sub-population that might benefit more from treatment and showed that all subgroups treated with the OptuneTM device benefited. The main adverse events attributable to this device were skin reactions and irritations. The results of the quality-of-life assessment indicate that the device is well tolerated by patients, as illustrated by the fact that the 75% adherence threshold was reached by 75% of the cohort. Skin irritation was the main cause of reduced quality of life in the cohort studied. Other results are subject to uncertainty due to the open design of the study, the low response of patients to the quality-of-life questionnaires, and the design of the device used, which was heavier, bulkier, and noisier than the model currently available. ORGANIZATIONAL DIMENSION: The OptuneTM device does not replace current care, but it is added to the standard maintenance treatment. GBM patients' diagnosis MRI images are transmitted to the manufacturer for array creation. Once the healthcare professional has assessed the patient's eligibility and transmitted the prescription to the manufacturer, the latter charges a monthly fee for unlimited array replacement, equipment delivery, patient service (technical assistance and training), and healthcare professional service, which includes training and reporting on patient compliance. This rental model is not common in Quebec, and the real involvement of healthcare network professionals and resources in monitoring patient use of the device is also uncertain, for example regarding skin effects, array repositioning and technical problems. However, Quebec centres participated in the EF-14 study and therefore have some experience with the device and the manufacturer. The OptuneTM device requires the help of a third party to place the electrode arrays, which may represent an issue for patients who have no family caregiver and/or for whom resources from the healthcare network could be solicited. Members of the advisory committee consulted are therefore of the opinion that, without access to such a resource, patients may be unable to use the device. In addition, there is uncertainty as to the optimal discontinuation criteria for patients treated with the OptuneTM device. Indeed, according to the members of the advisory committee consulted, there is no clinical advantage to continuing treatment after a first recurrence. Because of the organizational issues, several uncertainties remain as to whether the results of the clinical study can be reproduced in a real healthcare setting. ECONOMIC DIMENSION: The use of the OptuneTM device to treat patients with newly diagnosed glioblastoma concomitantly with temozolomide versus temozolomide alone is not cost-effective. Public coverage could generate additional costs of $ XX million over 5 years for the treatment of 308 patients. The real costs of adding the OptuneTM device, particularly those associated with its implementation in the health and social services network and with the involvement of healthcare personnel in patient follow-up, are uncertain. Market share for the OptuneTM device is also uncertain, since it depends on the quality of the manufacturer's service offering in Quebec, the organizational capacity of the Quebec healthcare network, and real patient acceptability. INESSS'S RECOMMENDATION: Based on the information available to date, and given the importance of the uncertainties raised, INESSS considers that it would not be fair and equitable to provide public coverage for the OptuneTM device for the treatment of adult patients with newly diagnosed supratentorial glioblastoma following maximal reduction surgery and completion of radiotherapy with and after standard maintenance chemotherapy. INESSS may reassess the OptuneTM device, at the request of the ministère de la Santé et des Services sociaux (MSSS), when more information becomes available, including data in reallife settings that will better reduce uncertainties and mitigate associated risks.
Asunto(s)
Humanos , Terapia por Estimulación Eléctrica/instrumentación , Neoplasias del Sistema Nervioso Central/tratamiento farmacológico , Glioblastoma/terapia , Evaluación en Salud/economía , Análisis Costo-Beneficio/economíaRESUMEN
⢠La Esclerosis Múltiple (EM) es una enfermedad neurodegenerativa y autoinmune, que se caracteriza por la presencia de desmielinización inflamatoria con afectación en la conducción axonal a diferentes niveles del sistema nervioso central. ⢠La sintomatología de la EM es muy variada, y puede provocar prácticamente cualquier síntoma neurológico atribuible a una lesión del SNC. Los problemas motores son percibidos como especialmente incapacitantes por pacientes y cuidadores. ⢠El dispositivo de neuromodulación portátil PoNS™ es un dispositivo de estimulación translingual, compacto y no implantable, que administra una leve estimulación eléctrica a las fibras nerviosas aferentes situadas en la superficie dorsal de la lengua, a través de pequeños electrodos. El dispositivo PoNS™ se ha utilizado en combinación con sesiones de entrenamiento de la marcha realizadas por fisioterapeutas. ⢠La evidencia científica disponible actualmente sobre el dispositivo de neuromodulación portátil PoNS™ para la ayuda a la marcha en EM es muy limitada para extraer conclusiones robustas sobre sus efectos, principalmente debido a los pocos estudios realizados y a sus pequeños tamaños muestrales (34 participantes en total). ⢠En los dos ensayos controlados aleatorizados identificados en este informe, las personas que utilizan el dispositivo PoNS™, en combinación con un programa individualizado de fisioterapia, mejoran de forma significativa su patrón de marcha tras 14 semanas de intervención. Sin embargo, sólo en uno de ellos, esa mejoría fue significativamente superior a la obtenida con estimulación simulada y fisioterapia. ⢠En general, la evidencia disponible destaca la vialidad y seguridad del uso del dispositivo PoNS™, sin embargo, se requieren ensayos clínicos de calidad, independientes de la industria y con muestras de tamaño apropiado, para determinar su eficacia como complemento de los programas de rehabilitación de la marcha en personas con EM.
⢠Multiple sclerosis (MS) is an autoimmune-mediated neurodegenerative disease characterized by inflammatory demyelination with axonal transection at different levels of the central nervous system. ⢠There is a wide range of symptoms associated with MS, and it can cause pretty much any neurological symptom caused by a central nervous system lesion. Patients and caregivers perceive motor problems as particularly disabling. ⢠The PoNS™ device is a non-implantable, translingual stimulation device that uses small electrodes to provide mild electrical stimulation to afferent nerve fibers located on the dorsal surface of the tongue. The PoNS™ device has been used in conjunction with gait training sessions conducted by physiotherapists. ⢠The current scientific evidence on the PoNS™ device for gait assistance in MS is too limited to draw robust conclusions about its effects, mainly due to the few studies conducted and the small sample sizes (34 participants in total). ⢠Two randomized controlled trials identified in this report found that people using the PoNS™ device with an individualized physical therapy program significantly improved their gait pattern after 14 weeks. In only one of them, however, this improvement was significantly greater than the obtained with simulated stimulation and physiotherapy. ⢠The available evidence indicates that the PoNS™ device is both feasible and safe. However, high-quality, industry-independent clinical trials with appropriate sample size are required to determine whether it is an effective adjunct to gait rehabilitation programs in people with MS.
Asunto(s)
Terapia por Estimulación Eléctrica/instrumentación , Esclerosis Múltiple/rehabilitación , Dispositivos de Autoayuda , Marcha , Esclerosis Múltiple/terapiaRESUMEN
OBJETIVO: Avaliar a eficácia da alta frequência na cicatrização de feridas por queimadura durante internação hospitalar. MÉTODO: Trata-se de um estudo de caso, realizado com uma voluntária do sexo feminino, 19 anos, em um hospital de pronto-socorro. Foram aplicados a alta frequência e curativos convencionais, com a amostra única sendo dividida em área de intervenção e área controle. Foram avaliados dados clínicos e sociodemográficos, registros fotográficos pré e pós as intervenções, dimensão da área da ferida por meio de planimetria digitalizada, aspecto da cicatriz através da Escala Vancouver e a qualidade de vida por meio do questionário Burn Specific Health Scale. RESULTADOS: A área da ferida teve redução de 54% na área de intervenção e 26% na área controle. Aspectos como vascularização e flexibilidade também apresentaram discreta melhora. O questionário de qualidade de vida reduziu dois pontos, relacionados à melhora da sensibilidade da pele e aos cuidados com a queimadura. CONCLUSÃO: A utilização de alta frequência combinada com uso de curativos durante a internação hospitalar mostrou resultados favoráveis em comparação a apenas o uso de curativos na cicatrização de feridas. Contudo, mais estudos são necessários.
OBJECTIVE: To evaluate the effectiveness of the high frequency in the healing of burn wounds during hospitalization. METHODS: This is a case study, conducted with a 19-year-old female volunteer, in an emergency room. The high frequency and conventional dressings were applied, with the single sample being divided into the intervention area and the control area. Clinical and sociodemographic data, photographic records before and after the interventions, dimension of the wound area through digitalized planimetry, the aspect of the scar through the Vancouver Scale and quality of life through the Burn Specific Health Scale questionnaire were evaluated. RESULTS: The wound area decreased 54% in the intervention area and 26% in the control area. Aspects such as vascularity and flexibility also showed a slight improvement. The quality of life questionnaire reduced two points, related to the improvement of skin sensitivity and care for burns. CONCLUSION: The use of the high frequency combined with the use of dressings during hospitalization showed favorable results compared to only the use of dressings in wound healing. However, more studies are needed.
Asunto(s)
Humanos , Femenino , Adulto , Cicatrización de Heridas , Quemaduras/terapia , Terapia por Estimulación Eléctrica/instrumentación , Sulfadiazina de Plata/administración & dosificación , Vendajes/provisión & distribuciónRESUMEN
OBJECTIVES/HYPOTHESIS: Upper airway stimulation has demonstrated marked improvements in apnea-hypopnea index, oxygen desaturation index, and quality-of-life measures in patients with moderate to severe obstructive sleep apnea (OSA) who cannot tolerate continuous positive airway pressure. Cardiac arrhythmias are common in patients with OSA and can require electrical cardioversion. We describe the first four reported cases of hypoglossal nerve stimulator (HGNS) dysfunction after electrical cardioversion and illustrate our operative approach to device troubleshooting and repair. STUDY DESIGN: Retrospective case series. METHODS: A retrospective review of 201 HGNS implantations performed at two academic institutions revealed four cases of HGNS device dysfunction after electrical cardioversion requiring surgical revision. Preoperative and postoperative device performance metrics and electrical cardioversion specifications were retrospectively assessed and compiled for this case series. The senior authors (R.J.S., M.S.B.) detail operative planning and approach for HGNS implantable pulse generator (IPG) replacement. RESULTS: At least two patients with HGNS device dysfunction had received cardioversion via anterolateral electrode pad placement. Three patients had received multiple shocks. All four patients experienced a change in device functionality or complete cessation of functionality after electrocardioversion. Operatively, each patient required replacement of the IPG, with subsequent intraoperative interrogation revealing proper device functionality. CONCLUSION: Counseling for patients with HGNS undergoing external electrical cardioversion should include possible device damage and need for operative replacement. Anteroposterior electrode pad placement should be considered for patients with HGNS who require electrocardioversion. Operative replacement of an HGNS system damaged by electrocardioversion begins with IPG replacement and intraoperative device interrogation. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:1949-1953, 2019.
Asunto(s)
Arritmias Cardíacas/terapia , Cardioversión Eléctrica/efectos adversos , Terapia por Estimulación Eléctrica/instrumentación , Falla de Equipo , Neuroestimuladores Implantables , Apnea Obstructiva del Sueño/terapia , Anciano , Arritmias Cardíacas/etiología , Femenino , Humanos , Nervio Hipogloso , Masculino , Calidad de Vida , Estudios Retrospectivos , Apnea Obstructiva del Sueño/complicacionesRESUMEN
Functional electrical stimulation cycling has been proposed as an assistive technology with numerous health and fitness benefits for people with spinal cord injury, such as improvement in cardiovascular function, increase in muscular mass, and reduction of bone mass loss. However, some limitations, for example, lack of optimal control strategies that would delay fatigue, may still prevent this technology from achieving its full potential. In this work, we performed experiments on a person with complete spinal cord injury using a stationary tadpole trike when both cadence tracking and disturbance rejection were evaluated. In addition, two sets of experiments were conducted 6 months apart and considering activation of different muscles. The results showed that reference tracking is achieved above the cadence of 25 rpm with mean absolute errors between 1.9 and 10% when only quadriceps are activated. The disturbance test revealed that interferences may drop the cadence but do not interrupt a continuous movement if the cadence does not drop below 25 rpm, again when only quadriceps are activated. When other muscle groups were added, strong spasticity caused larger errors on reference tracking, but not when a disturbance was applied. In addition, spasticity caused the last experiments to result in less smooth cycling.
Asunto(s)
Ciclismo , Terapia por Estimulación Eléctrica/métodos , Actividad Motora , Contracción Muscular , Músculo Cuádriceps/inervación , Traumatismos de la Médula Espinal/rehabilitación , Adulto , Fenómenos Biomecánicos , Terapia por Estimulación Eléctrica/instrumentación , Diseño de Equipo , Tolerancia al Ejercicio , Humanos , Masculino , Fatiga Muscular , Fuerza Muscular , Traumatismos de la Médula Espinal/diagnóstico , Traumatismos de la Médula Espinal/fisiopatología , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCCIÓN: La Enfermedad de Parkinson (EP) es la segunda enfermedad neurodegenerativa más común (después de la enfermedad de Alzheimer) en el sistema nervioso central, afectando principalmente el sistema motor. Actualmente los medicamentos antiparkinsonianos como levodopa y agonistas dopaminérgicos son la primera línea de tratamiento para EP. Estos medicamentos pueden mejorar los síntomas tempranos de EP, pero se vuelven inefectivos e incluso producen efectos adversos, como disquinesia y síntomas psicóticos, a medida que la enfermedad progresa. La terapia de estimulación cerebral profunda (ECP) o Deep Brain Stiumulation (DBS Therapy) es un tratamiento quirúrgico que puede reducir algunos de los síntomas asociados a la Enfermedad de Parkinson. Para esto, se utiliza un dispositivo médico implantado quirúrgicamente, similar a un marcapasos cardíaco, para administrar estimulación eléctrica en áreas muy definidas del cerebro. La estimulación de estas áreas bloquea las señales que causan los síntomas motores incapacitantes de la enfermedad de Parkinson. La estimulación eléctrica puede ajustarse de forma no invasiva para aumentar al máximo los beneficios de la terapia. Como resultado, muchas personas logran tener un mayor control sobre los movimientos de su cuerpo. TECNOLOGÍAS SANITARIA DE INTERÉS: La terapia de estimulación cerebral profunda (DBS Therapy) es un tratamiento quirúrgico que puede reducir algunos de los síntomas asociados a la EP. Para esto, se utiliza un dispositivo médico implantado quirúrgicamente, similar a un marcapasos cardíaco, para administrar estimulación eléctrica en áreas muy definidas del cerebro. La estimulación de estas áreas bloquea las señales que causan los síntomas motores incapacitantes de la enfermedad de Parkinson. La estimulación eléctrica puede ajustarse de forma no invasiva para aumentar al máximo los beneficios de la terapia. Como resultado, muchas personas logran tener un mayor control sobre los movimientos de su cuerpo. Este sistema cuenta con tres componentes: Electrodo: se compone de cuatro cables delgados aislados dispuestos en espiral con cuatro polos en la punta del electrodo. El electrodo se implanta en el cerebro. Extensión: se conecta al electrodo y se conduce bajo la piel desde la cabeza al tórax superior, pasando por el cuello. Neuroestimulador: se conecta a la extensión. Este pequeño dispositivo, similar a un marcapasos cardíaco, contiene una batería y componentes electrónicos. El neuroestimulador se implanta normalmente bajo la piel en el tórax, debajo de la clavícula (si el paciente lo requiere, el cirujano puede implantar el neuroestimulador en el abdomen). El denominado, a veces, "marcapasos del cerebro" genera los impulsos eléctricos necesarios para la estimulación. EFICACIA DE LOS TRATAMIENTOS: La ECP está asociada con un mejoramiento significativo en la función motora, calidad de vida y reducción de dosis de L-dopa Existe una posibilidad pequeña de serios eventos adversos como Hemorragia Subaracnoidea. Es necesario que la operación sea realizada por un equipo multidisciplinario y experimentado para asegurar la selección óptima de personas y reducir el riesgo de eventos adversos. ALTERNATIVAS DISPONIBLES: Tratamiento farmacológico: Destinados principalmente al alivio de síntomas de la enfermedad. Entre los fármacos que se utilizan para el tratamiento de síntomas motores se puede mencionar a levodopa, antagonistas de la dopamina, anticolinérgicos, amantadina e inhibidores de la monoamino oxidasa, entre otros. Por otro lado, se utilizan medicamentos para el tratamiento de síntomas no motores derivados de condiciones relacionadas (comorbilidades o secuelas del tratamiento) como psicosis, demencia, depresión y fatiga. Tratamiento no farmacológico: Entre las intervenciones no farmacológicas para el tratamiento de la enfermedad de Parkinson se encuentran educación, programas de apoyo, terapias de ejercicios y del lenguaje. Cirugía: Estimulador cerebral profundo. Es la técnica quirúrgica más utilizada en la actualidad y consiste en estimular eléctricamente a través de la implantación de electrodos en ciertas zonas del cerebro con el objetivo de controlar los síntomas del Parkinson. Otros procedimientos quirúrgicos: talamotomía, palidotomía, subtalamotomía, entre otros. RESULTADOS DE LA BÚSQUEDA DE EVIDENCIA: La información presentada fue extraída de 3 revisiones sistemáticas publicadas entre los años 2013 y 2016 que evaluaron el dispositivo de estimulación cerebral profunda en comparación con terapia farmacológica. A continuación, en la Tabla 1, se muestra un resumen con la evidencia encontrada. CONCLUSIÓN: Para dar cumplimiento al artículo 28° del Reglamento que establece el proceso destinado a determinar los diagnósticos y tratamientos de alto costo con Sistema de Protección Financiera, según lo establecido en los artículos 7° y 8° de la ley N°20.850, aprobado por el decreto N°13 del Ministerio de Salud, se concluye que el presente informe de evaluación se considera no favorable, dado el impacto en las redes asistenciales, de acuerdo a lo establecido en el Título III. de las Evaluaciones Favorables de la Norma Técnica N° 0192 de este mismo Ministerio.
Asunto(s)
Humanos , Enfermedad de Parkinson/rehabilitación , Terapia por Estimulación Eléctrica/instrumentación , Evaluación de la Tecnología Biomédica , Análisis Costo-Beneficio/economíaRESUMEN
BACKGROUND: Placing the right ventricular pacing electrode in different places than the apex is less deleterious to the ejection fraction and left ventricular synchrony. Currently it is not defined which non apical site is better alternative. The aim of this paper was to determine if there is a difference in systolic function and left ventricular synchrony with stimulation of medial septum or outflow tract of the right ventricle in patients with atrioventricular block and pacemaker device. METHODS: This was an observational analytical cross study. The patients included in this study were the population over 18 years old, diagnosed with atrioventricular block and pacemaker device. Two groups were divided according to the site of electrode placement whether in medial septum region or outflow tract of the right ventricle. The ejection fraction and left ventricular synchrony was determined by echocardiogram. RESULTS: 54 patients were included in each group, with similar demographic characteristics, except for the time of placement of ventricular electrode (p = < 0.001). No significant difference in ejection fraction or left ventricular synchrony was found. CONCLUSIONS: There were no differences in ejection fraction or left ventricular synchrony regardless of the ventricular electrode placement.
Introducción: el objetivo del presente estudio fue determinar si existe diferencia en la función sistólica y la sincronía del ventrículo izquierdo con estimulación del septum medio o tracto de salida del ventrículo derecho en pacientes con bloqueo auriculoventricular portadores de marcapaso. Métodos: estudio observacional, analítico, transversal. Se seleccionaron todos los pacientes mayores de 18 años portadores de marcapaso con diagnóstico de bloqueo auriculoventricular. Se analizaron dos grupos acorde al sitio de colocación del electrodo de estimulación en región septal media o tracto de salida del ventrículo derecho. Se determinó la fracción de expulsión y sincronía del ventrículo izquierdo. Resultados: se incluyeron 54 pacientes por cada grupo, siendo las características de ambos similares, excepto el tiempo de colocación del electrodo de estimulación ventricular (p = < 0.001). No hubo diferencia significativa en la fracción de expulsión o sincronía del ventrículo izquierdo. Conclusiones: no se encontró diferencia en la fracción de expulsión o sincronía del ventrículo izquierdo independientemente del sitio de colocación del electrodo de estimulación.
Asunto(s)
Bloqueo Atrioventricular/terapia , Terapia por Estimulación Eléctrica/métodos , Ventrículos Cardíacos/fisiopatología , Marcapaso Artificial , Función Ventricular Izquierda/fisiología , Adulto , Anciano , Bloqueo Atrioventricular/fisiopatología , Estudios Transversales , Terapia por Estimulación Eléctrica/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Volumen Sistólico , Resultado del TratamientoRESUMEN
Objetivo: Este estudo que visou analisar os efeitos de um programa de treinamento muscular através da EENM de membros inferiores (MMII) e exercícios ativos resistidos de MMSS em pacientes portadores de Doença Pulmonar Obstrutiva Crônica (DPOC) grave. Métodos: A amostra foi constituída por 5 sujeitos com idade média de 65,2 ± 6,09 anos. As avaliações iniciais e finais, compreenderam os testes: uma repetição máxima; senta-levanta; perimetria das coxas; caminhada de seis minutos; questionário St George; escala de dispneia MRC; índice de BODE. A intervenção foi realizada três vezes/semana, totalizando 18 sessões de 30 min de Estimulação elétrica neuromuscular (EENM) e 30 min de treinamento membros superiores, com uso de diagonais do Método Kabat. Os parâmetros da EENM foram: frequência 50 Hz, Ton 6s, Toff 8s, rampa de subida 2s, rampa de descida 2s, largura de pulso 400 µs e intensidade conforme a tolerância do paciente, aumentada em 1 a 5 mA a cada dia. Resultados: Mostraram aumento da força muscular (p = 0,01) e da resistência muscular (p = 0,01). Verificou-se uma tendência à melhora na qualidade de vida (p = 0,16) e na aptidão cardiorrespiratória (p = 0,11). Conclusão: A associação de EENM e exercícios com diagonais pode ser um recurso valioso para o tratamento dos pacientes com DPOC grave. Entretanto, sugere-se pesquisas com um maior número amostral para comprovar seus benefícios
Objective: The objective of this study was to analyze the effects of a muscle training program with neuromuscular electrical stimulation (NMES) for lower limbs (LL) and active resisted exercises for upper limbs (UL) for patients with severe Chronic Obstructive Pulmonary Disease. Methods: With a sample of 5 subjects (65.2 ± 6.09 years), the initial and final evaluations were: One-Repetition-Maximum testing; Sit-to-stand test; perimetry of the thigh; 6-minute walk test; Saint George's Respiratory Questionnaire; Medical Research Council scale for dyspnea and the BODE index. The intervention was performed three times a week and was composed of 18 sessions of 30-minute NMES followed by 30 minutes of exercise for the UL based on the diagonal Kabat method. The NMES parameters were: 50Hz of frequency, 6s on and 8s off, increase slope of 2s and decrease slope of 2s, pulse width of 400µs, and intensity defined as patient tolerance and increased from 1 to 5mA each day. Results: The results have shown an increase in muscle strength (p = 0.01) and of muscle resistance (p = 0.01). There was an improvement tendency in the quality of life (p = 0.16) and in the cardiorespiratory fitness (p = 0.11). Conclusion: The association of physical exercises with diagonals and NMES can be a beneficial resource for the treatment of patients with severe COPD. It is suggested, however, the need for new researches with a wider sample size for assuring these benefits
Asunto(s)
Calidad de Vida , Tolerancia al Ejercicio , Enfermedad Pulmonar Obstructiva Crónica/patología , Terapia por Estimulación Eléctrica/instrumentación , Encuestas y CuestionariosRESUMEN
Objetivo: Analisar os diferentes métodos de Eletroestimulação Neuromuscular (EENM) na intervenção das disfagias orofaríngeas. Metódos: Revisão através dos descritores: "transtornos de deglutição" e "estimulação elétrica" nas bases PubMed, BVS, SciELO e MedLine, de 1997 a 2015. Classificados segundo Sistema Integrado CAPES (SiCAPES), Escala PEDro e Jadad. Resultados: 165 artigos encontrados. 25 selecionados de acordo com o tema proposto. Entre 2009-2012 (60%, n = 15) ocorreu maior número de publicações. Caso Controle foi o tipo de estudo mais relatado (28%, n = 7). A maioria investigou indivíduos pós acidente vascular cerebral (44%, n = 11). O tipo de terapia mais recorrente considera EENM em repouso e terapia tradicional (TT) (28%, n = 8), EENM durante a deglutição e TT (28%, n = 7) e EENM em repouso (24%, n = 3). Vital Stim® foi o aparelho de eletroestimulação mais citado (32%, n = 8). A eletroestimulação transcutânea foi a mais relatada (76%, n = 19). Quanto à localização, destacam-se eletrodos fixados na região do pescoço (48%, n = 12) e submentual (44%, n =11). Correntes mais utilizadas: FES (40%, n = 10) e TENS (24%, n = 6). Videofluoroscopia é o método de avaliação predominante (52%, n = 13). Pela distribuição SiCAPES o maior número de materiais classificam-se em B2 (36%, n = 9) e A1 (16%, n=4). Na Escala PEDro os trabalhos pontuaram, principalmente, em 11 (24%, n = 6) e 10 (16%, n = 4). Considerando a Escala Jadad, (24%, n = 6) estudos obtiveram 3 pontos. Conclusão: Observou-se maior prevalência de efeito terapêutico na elevação do complexo hiolaríngeo, importante mecanismo de defesa das vias respiratórias durante a deglutição, utilização da corrente FES, e eletrodos posicionados na região submentual ou de pescoço. Novas pesquisas são necessárias, com grupos etiológicos definidos, para comprovação do efeito terapêutico a médio e longo prazo
Objective: To analyze the different methods of Neuromuscular Electrical Stimulation (NMES) in the intervention of oropharyngeal dysphagia. Methods: Review using the descriptors: "deglutition disorders" and "electrical stimulation" in PubMed, BVS, SciELO, and MedLine, from 1997 to 2015. Classified according to the CAPES Integrated System (SiCAPES), PEDro, and Jadad scales. Results: There were 165 articles found, from which 25 were selected according to the theme. Between 2009-2012 there were more publications (60%, n = 15). Case-control was the most reported type of study (28%, n = 7). Most individuals were investigated after a stroke (44%, n = 11). The most popular type of therapy considered NMES at rest and traditional therapy (TT) (28%, n = 8), NMES during swallowing and TT (28%, n = 7), and NMES at rest (24%, n = 3). Vital Stim® was the most cited electrical stimulation device (32%, n = 8). Transcutaneous electrical nerve stimulation was the most reported (76%, n = 19). As to location, electrodes placed on the neck (48%, n = 12) and submental (44%, n = 11) stood out. Electric current commonly used: FES (40%, n = 10) and TENS (24%, n = 6). Fluoroscopy was the prevailing evaluation method (52%, n = 13). For SiCAPES distribution, the greatest number of materials was classified as B2 (36%, n = 9) and A1 (16%, n = 4). On the PEDro scale, the studies mostly scored 11 (24%, n = 6) and 10 (16%, n = 4). Considering the Jadad scale, (24%, n = 6) the studies scored 3 points. Conclusion: A higher prevalence of therapeutic effect on hyolaryngeal complex elevation, an important airway defense mechanism during swallowing, and the use of FES current and electrodes placed on the submental region or neck. Further research is needed, with defined etiological groups, to prove the therapeutic effect in the medium and long term
Asunto(s)
Humanos , Trastornos de Deglución/rehabilitación , Terapia por Estimulación Eléctrica/instrumentación , Fluoroscopía , Accidente CerebrovascularRESUMEN
BACKGROUND: Striae distensae are linear atrophic dermal scars with associated epidermal atrophy. This recurrent skin disorder causes a significant cosmetic and psychologic concern and remains a therapeutic challenge, especially when they are mature and hypopigmented (striae alba). AIMS: In this prospective single-center study, we evaluated the efficacy, safety, and patient's satisfaction of galvanopuncture for the treatment of striae alba. PATIENTS/METHODS: Thirty-two female subjects with striae alba present on the buttocks were treated with galvanopuncture once a week over a period of 10 weeks. Photographs and a percentage category scale were used to assess striae improvement and patient's satisfaction. Biochemical analyses were performed to assess possible systemic inflammatory effects or oxidative stress induction by the treatment. RESULTS: All patients achieved a substantial increase in clinical improvement in their striae within 10 treatment sessions. Galvanopuncture did not induce any inflammatory effect; however, it reduced oxidative injury. CONCLUSION: The use of galvanopuncture for the treatment of striae alba demonstrated a significant improvement in the lesions with visible results. This study supports the high degree of patient's satisfaction and demonstrate the safe and effective use of galvanopuncture in the treatment of striae alba on several skin types.
Asunto(s)
Terapia por Estimulación Eléctrica/métodos , Inflamación/sangre , Estrés Oxidativo , Estrías de Distensión/terapia , Adulto , Proteína C-Reactiva/metabolismo , HDL-Colesterol/sangre , LDL-Colesterol/metabolismo , Terapia por Estimulación Eléctrica/efectos adversos , Terapia por Estimulación Eléctrica/instrumentación , Femenino , Humanos , Inflamación/diagnóstico , Inflamación/etiología , Lipoproteínas LDL/sangre , Agujas , Óxido Nítrico/sangre , Satisfacción del Paciente , Proyectos Piloto , Estudios Prospectivos , Sustancias Reactivas al Ácido Tiobarbitúrico/metabolismo , Factor de Necrosis Tumoral alfa/sangre , Adulto JovenRESUMEN
Rapid advances are occurring in neural engineering, bionics and the brain-computer interface. These milestones have been underpinned by staggering advances in micro-electronics, computing, and wireless technology in the last three decades. Several cortically-based visual prosthetic devices are currently being developed, but pioneering advances with early implants were achieved by Brindley followed by Dobelle in the 1960s and 1970s. We have reviewed these discoveries within the historical context of the medical uses of electricity including attempts to cure blindness, the discovery of the visual cortex, and opportunities for cortex stimulation experiments during neurosurgery. Further advances were made possible with improvements in electrode design, greater understanding of cortical electrophysiology and miniaturisation of electronic components. Human trials of a new generation of prototype cortical visual prostheses for the blind are imminent. This article is part of a Special Issue entitled Hold Item.
Asunto(s)
Terapia por Estimulación Eléctrica/historia , Corteza Visual , Prótesis Visuales/historia , Animales , Terapia por Estimulación Eléctrica/instrumentación , Terapia por Estimulación Eléctrica/métodos , Historia del Siglo XVIII , Historia del Siglo XIX , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Diseño de Prótesis , Corteza Visual/fisiología , Corteza Visual/fisiopatologíaRESUMEN
We report the case of a child with tetraplegia after cervical trauma, who subsequently underwent diaphragmatic pacemaker implantation. We reviewed the major indications for diaphragmatic pacing and the types of devices employed. We highlight the unequivocal benefit of diaphragmatic pacing in the social and educational reintegration of individuals with tetraplegia.
Relatamos o caso de uma criança tetraplégica após trauma cervical que foi posteriormente submetida a implante de marca-passo diafragmático. Revisamos as principais indicações da estimulação diafragmática e os tipos de dispositivos empregados, assim como apontamos o inequívoco benefício da reinserção socioeducacional desses indivíduos na sociedade.
Asunto(s)
Diafragma , Terapia por Estimulación Eléctrica/instrumentación , Marcapaso Artificial , Nervio Frénico , Cuadriplejía/complicaciones , Respiración Artificial/instrumentación , Cirugía Torácica Asistida por Video , Anestesia/métodos , Niño , Terapia por Estimulación Eléctrica/métodos , Electrodos Implantados , Humanos , Masculino , Implantación de Prótesis/métodos , Respiración Artificial/métodos , Traumatismos de la Médula Espinal/complicacionesRESUMEN
We report the case of a child with tetraplegia after cervical trauma, who subsequently underwent diaphragmatic pacemaker implantation. We reviewed the major indications for diaphragmatic pacing and the types of devices employed. We highlight the unequivocal benefit of diaphragmatic pacing in the social and educational reintegration of individuals with tetraplegia.
Relatamos o caso de uma criança tetraplégica após trauma cervical que foi posteriormente submetida a implante de marca-passo diafragmático. Revisamos as principais indicações da estimulação diafragmática e os tipos de dispositivos empregados, assim como apontamos o inequívoco benefício da reinserção socioeducacional desses indivíduos na sociedade.
Asunto(s)
Niño , Humanos , Masculino , Diafragma , Terapia por Estimulación Eléctrica/instrumentación , Marcapaso Artificial , Nervio Frénico , Cuadriplejía/complicaciones , Respiración Artificial/instrumentación , Cirugía Torácica Asistida por Video , Anestesia/métodos , Electrodos Implantados , Terapia por Estimulación Eléctrica/métodos , Implantación de Prótesis/métodos , Respiración Artificial/métodos , Traumatismos de la Médula Espinal/complicacionesRESUMEN
Pelvic floor dysfunction is a highly prevalent functional pathology that affects women and can present with different clinical symptoms that include urinary urgency with or without incontinence, diurnal and nocturnal frequency, urinary retention, fecal incontinence, obstructive defecation, sexual dysfunction and pelvic pain. Lately, concern arised as to offer patients an advanced therapy within an integral approach. This interest was first focused in sacral nerve root modulation, a key element for pelvic function. Neuromodulation is considered a normal characteristic of the nervous system that regulates or modifies the electric impulses that come from different nervous body tissues. Neuromodulation is carried out through sacral neurostimulation (SNS), posterior tibial nerve stimulation (PNTS), which are reversible non destructive therapies used for peripheric stimulation of nerves, ganglia, spinal medula and brain. Even though there is evidence of efficacy for sacral nerve stimulation at short, medium and long-term, there are two main concerns within this approach: invasivity and high cost. It seems posterior nerve tibial stimulation has the same neuromodulatory effect as the one obtained by sacral nerve stimulation through a less invasive route and lower cost.
Asunto(s)
Terapia por Estimulación Eléctrica , Trastornos del Suelo Pélvico/terapia , Nervio Tibial , Terapia por Estimulación Eléctrica/instrumentación , Terapia por Estimulación Eléctrica/métodos , Diseño de Equipo , Femenino , HumanosRESUMEN
BACKGROUND: Although electrical stimulation of the larynx has been widely studied for treating voice disorders, its effectiveness has not been assessed under safety and comfortable conditions. This article describes design, theoretical issues, and preliminary evaluation of an innovative system for transdermal electrical stimulation of the larynx. The proposed design includes synchronization of electrical stimuli with laryngeal neuromuscular activity. OBJECTIVE: To study whether synchronous electrical stimulation of the larynx could be helpful for improving voice quality in patients with dysphonia due to unilateral recurrent laryngeal nerve paralysis (URLNP). MATERIALS AND METHODS: A 3-year prospective study was carried out at the Instituto Nacional de Rehabilitacion in the Mexico City. Ten patients were subjected to transdermal current electrical stimulation synchronized with the fundamental frequency of the vibration of the vocal folds during phonation. The stimulation was triggered during the phase of maximum glottal occlusion. A complete acoustic voice analysis was performed before and after the period of electrical stimulation. RESULTS: Acoustic analysis revealed significant improvements in all parameters after the stimulation period. CONCLUSION: Transdermal synchronous electrical stimulation of vocal folds seems to be a safe and reliable procedure for enhancing voice quality in patients with (URLNP).
Asunto(s)
Disfonía/terapia , Terapia por Estimulación Eléctrica/métodos , Músculos Laríngeos/fisiología , Parálisis de los Pliegues Vocales/terapia , Voz/fisiología , Adulto , Disfonía/fisiopatología , Terapia por Estimulación Eléctrica/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Nervio Laríngeo Recurrente/fisiopatología , Acústica del Lenguaje , Resultado del Tratamiento , Parálisis de los Pliegues Vocales/fisiopatología , Pliegues Vocales/fisiología , Adulto JovenAsunto(s)
Terapia por Estimulación Eléctrica/instrumentación , Hipoventilación/diagnóstico , Hipoventilación/terapia , Trastornos Parkinsonianos/diagnóstico , Trastornos Parkinsonianos/terapia , Nervio Frénico/fisiología , Colombia , Depresión/diagnóstico , Depresión/genética , Depresión/terapia , Diafragma/inervación , Diafragma/cirugía , Complejo Dinactina , Terapia por Estimulación Eléctrica/métodos , Femenino , Humanos , Hipoventilación/genética , Proteínas Asociadas a Microtúbulos/genética , Persona de Mediana Edad , Trastornos Parkinsonianos/genética , Resultado del TratamientoRESUMEN
The idea that magnetic fields could be used therapeutically arose 2000 years ago. These therapeutic possibilities were expanded after the discovery of electromagnetic induction by the Englishman Michael Faraday and the American Joseph Henry. In 1896, Arsène d'Arsonval reported his experience with noninvasive brain magnetic stimulation to the scientific French community. In the second half of the 20th century, changing magnetic fields emerged as a noninvasive tool to study the nervous system and to modulate neural function. In 1985, Barker, Jalinous, and Freeston presented transcranial magnetic stimulation, a relatively focal and painless technique. Transcranial magnetic stimulation has been proposed as a clinical neurophysiology tool and as a potential adjuvant treatment for psychiatric and neurologic conditions. This article aims to contextualize the progress of use of magnetic fields in the history of neuroscience and medical sciences, until 1985.
Asunto(s)
Campos Magnéticos , Estimulación Magnética Transcraneal/historia , Animales , Encéfalo/fisiología , Terapia por Estimulación Eléctrica/historia , Terapia por Estimulación Eléctrica/instrumentación , Terapia por Estimulación Eléctrica/métodos , Electricidad , Historia del Siglo XV , Historia del Siglo XVIII , Historia del Siglo XIX , Historia del Siglo XX , Historia Antigua , Historia Medieval , Humanos , Neurociencias/historia , Neurociencias/instrumentación , Neurociencias/métodos , Estimulación Magnética Transcraneal/instrumentación , Estimulación Magnética Transcraneal/métodosRESUMEN
In this retrospective case study, we report the apparent clinical effectiveness of neuromuscular electrical stimulation (NMES) in combination with voice therapy (VT) for rehabilitating dysphonia secondary to suspected superior laryngeal nerve (SLN) weakness in two female patients. Both patients failed or plateaued with traditional VT but had significant improvement with the addition of NMES of the cricothyroid muscle and SLN using a VitalStim unit. Stimulation was provided simultaneously with voice exercises based on musical phonatory tasks. Both acoustic analysis and endoscopic evaluation demonstrated important improvements after treatment. In the first patient, the major change was obtained within the primo passaggio region; specifically, a decrease in voice breaks was demonstrated. In the second patient, an improvement in voice quality (less breathiness) and vocal range were the most important findings. Additionally, each patient reported a significant improvement in their voice complaints. Neuromuscular laryngeal electrical stimulation in combination with vocal exercises might be a useful tool to improve voice quality in patients with SLN injury.
Asunto(s)
Terapia por Estimulación Eléctrica/instrumentación , Músculos Laríngeos/inervación , Nervios Laríngeos/fisiopatología , Prótesis Neurales , Fonación , Canto , Parálisis de los Pliegues Vocales/terapia , Calidad de la Voz , Entrenamiento de la Voz , Acústica , Terapia Combinada , Femenino , Humanos , Persona de Mediana Edad , Recuperación de la Función , Estudios Retrospectivos , Espectrografía del Sonido , Factores de Tiempo , Resultado del Tratamiento , Parálisis de los Pliegues Vocales/diagnóstico , Parálisis de los Pliegues Vocales/fisiopatologíaRESUMEN
CONTEXT: Biofeedback has been used successfully in the treatment of fecal incontinence, working mainly on rehabilitation of the sphincter muscle. However, there are few studies presenting objective results of biofeedback, in terms of functional results and those related to the quality of life. OBJECTIVES: The aims of this study was to evaluate the immediate results of biofeedback in the treatment of fecal incontinence and its impact on the quality of life of patients by using validated questionnaires, correlating the results with those related to functional parameters of quality of life and clinical variables. METHODS: We analyzed and compared the results of biofeedback in 52 patients with fecal incontinence before the start of the sessions and immediately after the end of them, by applying validated questionnaires assessing the degree of intensity of fecal incontinence (FISI - Fecal Incontinence Severity Index) and evaluation of quality of life related to fecal incontinence (FIQL - Faecal Incontinence Quality of Life Scale) as compared to clinical variables (age, onset of symptoms, etiology of the fecal incontinence, number of sessions of biofeedback and number and types of deliveries). RESULTS: The evaluation of the results of FISI showed a significant increase in the number of individuals who had low severity scores of symptoms before and after the biofeedback (from 48.1 to 65.4%) with P = 0.004. There was significant improvements in domains of the FIQL, behavior (P = 0.008), depression (P = 0.006) and embarrassment (P = 0.008) after biofeedback. There was no significant correlation between the improvement of functional parameters evaluated by FISI and the improvement of quality of life. Positive correlation was found between the improvements of the domains of FIQL. There was no significant correlation between the results obtained using the FISI and FIQL with clinical variables assessed. CONCLUSIONS: Biofeedback has proven to be an effective therapy in the treatment of fecal incontinence, improving symptoms and/or quality of life for most patients, regardless of clinical presentation of this functional disorder.