Medical Devices; Neurological Devices; Classification of the External Upper Limb Tremor Stimulator. Final order.

The Food and Drug Administration (FDA or we) is classifying the external upper limb tremor stimulator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external upper limb tremor stimulator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms. Final order.

The Food and Drug Administration (FDA or we) is classifying the intranasal electrostimulation device for dry eye symptoms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intranasal electrostimulation device for dry eye symptoms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device. Final order.

The Food and Drug Administration (FDA or we) is classifying the tear electrostimulation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the tear electrostimulation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Surgical anatomy of the hypoglossal nerve: A new classification system for selective upper airway stimulation.

BACKGROUND: Selective upper airway stimulation (UAS) has shown effectiveness in treating patients with obstructive sleep apnea (OSA). The terminating branches of the hypoglossal nerve show a wide complexity, requiring careful discernment of a functional breakpoint between branches for inclusion and exclusion from the stimulation cuff electrode. The purpose of this study was to describe and categorize the topographic phenotypes of these branches. METHODS: Thirty patients who received an implant with selective UAS from July 2015 to June 2016 were included. All implantations were recorded using a microscope and resultant tongue motions were captured perioperatively for comparison. RESULTS: Eight different variations of the branches were encountered and described, both in a tabular numeric fashion and in pictorial schema. CONCLUSION: The examinations showed the complex phenotypic surgical anatomy of the hypoglossal nerve. A schematic classification system has been developed to help surgeons identify the optimal location for cuff placement in UAS.

Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache. Final order.

The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Dental Devices; Reclassification of Electrical Salivary Stimulator System. Final order.

The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the "electrical salivary stimulator system." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Classification of methods in transcranial electrical stimulation (tES) and evolving strategy from historical approaches to contemporary innovations.

Transcranial Electrical Stimulation (tES) encompasses all methods of non-invasive current application to the brain used in research and clinical practice. We present the first comprehensive and technical review, explaining the evolution of tES in both terminology and dosage over the past 100 years of research to present day. Current transcranial Pulsed Current Stimulation (tPCS) approaches such as Cranial Electrotherapy Stimulation (CES) descended from Electrosleep (ES) through Cranial Electro-stimulation Therapy (CET), Transcerebral Electrotherapy (TCET), and NeuroElectric Therapy (NET) while others like Transcutaneous Cranial Electrical Stimulation (TCES) descended from Electroanesthesia (EA) through Limoge, and Interferential Stimulation. Prior to a contemporary resurgence in interest, variations of transcranial Direct Current Stimulation were explored intermittently, including Polarizing current, Galvanic Vestibular Stimulation (GVS), and Transcranial Micropolarization. The development of these approaches alongside Electroconvulsive Therapy (ECT) and pharmacological developments are considered. Both the roots and unique features of contemporary approaches such as transcranial Alternating Current Stimulation (tACS) and transcranial Random Noise Stimulation (tRNS) are discussed. Trends and incremental developments in electrode montage and waveform spanning decades are presented leading to the present day. Commercial devices, seminal conferences, and regulatory decisions are noted. We conclude with six rules on how increasing medical and technological sophistication may now be leveraged for broader success and adoption of tES.

Estudio Delphi sobre terminología vinculada a electroterapia entre profesores de la materia / Delphi study on terminology related to electrotherapy among teachers of the subject

Se presenta un estudio Delphi sobre si una serie de términos se debe o no vincular al marco conceptual de la electroterapia. Para realizar el estudio se contactó con los responsables de impartir los contenidos de electroterapia en las universidades españolas. Tras los datos obtenidos, nos encontramos con términos donde apenas existen dudas, como TENS, interferenciales, diadinámicas, corrientes de Träbert, microcorrientes, ultrasonidos, sonoforesis, ondas de choque o ultravioletas. Por otra parte, hay una falta de acuerdo sobre si pertenecen o no a la electroterapia términos como iontoforesis, microondas, onda corta, magnetoterapia, láser o infrarrojos. En este caso, nos encontramos con dos situaciones que nos exigen que debamos aclarar adecuadamente cuál es el marco conceptual de la electroterapia (AU)

A Delphi study regarding whether a series of terms should be linked to the conceptual framework of electrotherapy. To do so, national experts who teach this subject in the Spanish Universities were contacted. Based on the results obtained, we have found terms in which there is almost complete consensus: TENS, Inteferential Current, Diadynamic Current, Träbert Current, Microcurrent, Ultrasound, Phonophoresis, Shockwave or Ultraviolet Therapy. On the other hand, consensus is lacking on whether the following terms belong within electrotherapy terminology: Iontophoresis, Shortwave and Microwave Diathermy, Magnetic Therapy, Laser or Infrared radiation. Thus, there are two situations that make it necessary for us to adequately clarify what is the conception framework of electrotherapy (AU)

Seguimiento del paciente con marcapasos. Disfunciones del sistema de estimulación. Efectos de indicación o programación incorrecta: síndrome de marcapasos / Following up patients with pacemakers. Pacemaker system dysfunction. Effect of incorrect indications or programming: pacemaker syndrome

El funcionamiento adecuado de un sistema de estimulación cardiaca depende de una indicación, modo de estimulación y seguimiento correctos. El seguimiento debe seguir un protocolo que incluya personal especializado, test de umbral de estimulación y detección, análisis de batería, electrodos y arritmias, con una periodicidad determinada, directamente con el paciente y/o por contactos telemétricos desde el domicilio del paciente. En segundo lugar, se analizan los problemas objetivados tanto en estimulación como en detección en cada una de las cámaras cardiacas. Por último, se lleva a cabo una actualización del síndrome de marcapasos (AU)

Proper functioning of a cardiac pacemaker system depends on the indication and the pacing mode being appropriate, and on close follow-up. Follow-up must be carried out in accordance with a protocol that involves specialist personnel, and the assessment of sensing and pacing thresholds, battery condition, electrode condition, and arrhythmias. Follow-up should be carried out at a specified time interval either with the patient present or at the patient’s home via telemetry. This article also describes the problems arising with both pacing and sensing in each of the heart chambers. Finally, there is an update on pacemaker syndrome (AU)

Contribución del método Brunnstrom al tratamiento fisioterápico del pacientehemipléjico adulto / Brunnstrom's method contribution to the physical therapy treatment of adult hemiplegic patient

Dentro del gran numero de posibilidades terapéuticas de reeducación neuromuscular ante una hemiplejía, se encuentra el enfoque particular que ofreció Signe Brunnstrom, y que fue continuado por Sawner y LaVigne (USA) y Sultana (Francia) entre otros, si bien no hay estudios que demuestren la mayor eficacia de unos métodos frente a otros. Basado fundamentalmente en una detallada observación de los principales problemas de los pacientes hemipléjicos, Brunnstrom propuso la estimulación del control sinérgico del movimiento mediante el uso de reflejos, reacciones asociadas y estímulos aferentes, sin esfuerzo voluntario. Posteriormente serian modificadas para permitir el acercamiento a un movimiento mas normal, gracias al descenso del tono muscular y al control voluntario. Una de sus principales aportaciones fue la clasificación de la evolución del paciente en siete etapas y la evaluación de las mismas y las propuestas de entrenamiento para resolver los problemas sensoriomotores del paciente, desde la postura en cama, sentado, en pie y preparando la marcha, en cada una de las etapas (AU)

Advances in gastrointestinal electrical stimulation.

Electrical stimulation of the gastrointestinal (GI) tract, analogous to pacing the human heart, is an attractive idea. This is because these organs, like the heart, have their own natural pacemakers, and the electrical signals they generate can be altered by externally delivering certain types of electric currents via intraluminal or serosal electrodes to certain areas of the GI tract. A number of studies on animals have been accomplished successfully to treat a variety of disease models, including gastroparesis, dumping, and short bowel syndrome. Over the past 10 years or so, electrical stimulation of the GI tract has received increasing attention among researchers and clinicians because of new techniques, such as implantable devices, and promising results achieved in treatment of gastroparesis and morbid obesity. The objective of this article is to review the advances in electrical stimulation of the gastrointestinal tract. First the electrophysiology of the GI tract and history of GI electrical stimulation are introduced. Then various methods of electrical stimulation of the stomach and small bowel in healthy animals and models of GI diseases are reviewed. Finally clinical applications of electrical stimulation to GI disorders and their possible mechanisms are discussed.

Can muscle models improve FES-assisted walking after spinal cord injury?

Some persons with a spinal cord injury can use functional electrical stimulation (FES) to walk again, but many cannot, and for those that can the walking obtained is limited. This paper argues that muscle models can help improve FES systems, but only if these muscle models are enhanced. Part 1 reviews differences between muscle models for FES systems and those for "natural" movement; FES models emphasize limb angle, demand simplicity, exploit feedback, and grade force through recruitment rather than rate coding. Part 2 tells how FES systems have used muscle models. Those that do not use muscle models to control stimulation do not fare well, although two recent ones (rule-based control and neural-net control with feedback) may yet do so. Those that do use muscle models provide good control initially, but fare poorly as the muscle properties change. Part 3 lists important questions that muscle models must address: questions of goal, type of activation, spasticity, simulation, simplicity, and fatigue. If these features can be incorporated, models can improve both the design and control of FES systems.

Effects of low voltage pulsed current on edema formation in frog hind limbs following impact injury.

The purpose of this study was to test the effect of low voltage pulsed current (LVPC) on posttraumatic edema formation in frog hind limbs. Feet of 26 anesthetized bullfrogs were systematically injured by weight drop. One hind limb of each animal was randomly selected to receive continuous 100-pps LVPC at 90% of motor threshold; the opposite hind limb served as a control. A series of four 30-minute treatments (interrupted by 30-minute rests) was begun minutes after injury. Changes from pretrauma limb volumes were determined before and after each treatment and at 8, 17, 20, and 24 hours posttrauma. Analysis of variance revealed no significant treatment effect. Similar studies utilizing high voltage pulsed current (HVPC) at 90% of motor threshold revealed significant curbing of edema formation in frogs. Waveform (LVPC versus HVPC) seems to influence the efficacy of electrotherapy for edema control.