Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache. Final order.

The Food and Drug Administration (FDA or we) is classifying the thermal vestibular 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 thermal vestibular 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.

Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders. Final order.

The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders 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 percutaneous nerve stimulator for substance use disorders' 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; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. 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.

The effects of ULF-TENS stimulation on gnathology: the state of the art.

AIMS: The aim of this study was to evaluate the state of the art in the current literature regarding the effect of ultra low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) on patients with temporomandibular disorders (TMD). METHODOLOGY: The authors reviewed the literature through a thorough manual and electronic research on PubMed database (using the Medical Subject Headings thesaurus) and subsequent analysis of all the found papers regarding the effect of TENS on TMD patients. No randomized controlled trials on the investigated topic were found. Only eight papers regarding controlled clinical trials (CCT) were selected according to the search strategy selection criteria. RESULTS: According to the available literature and the authors' experience, ULF-TENS seems to be a valid support in the management of TMD patients, but also a 'provocative' tool, so its application should always be monitored by electromyographic and electrognathographic analysis (before and after TENS). CONCLUSIONS: Further clinical studies (mainly randomized controlled trials) on ULF-TENS application in neuromuscular gnathology are needed.

Peripheral nerve stimulation: definition.

Recently, there has been a tremendous evolution in the field of neurostimulation, both from the technological point of view and from development of the new and different indications. In some areas, such as peripheral nerve stimulation, there has been a boom in recent years due to the variations in the surgical technique and the improved results documented by in multiple published papers. All this makes imperative the need to classify and define the different types of stimulation that are used today. The confusion arises when attempting to describe peripheral nerve stimulation and subcutaneous stimulation. Peripheral nerve stimulation, in its pure definition, involves implanting a lead on a nerve, with the aim to produce paresthesia along the entire trajectory of the stimulated nerve.

¿Qué respuesta fisiológica desencadena la aplicación de la técnica de estimulación nerviosa eléctrica transcutánea? / Which physiological response triggers the application of the transcutaneous electrical nerve stimulation technique?

Objetivo. Revisar qué efectos fisiológicos tiene la aplicación de la técnica de estimulación nerviosa eléctrica transcutánea (TENS) sobre los pacientes, de modo que pueda servir de orientación para su correcta aplicación en la práctica clínica. La técnica TENS consiste en la aplicación de corriente eléctrica pulsada, tradicionalmente empleada con finalidad analgésica. A la hora de su utilización, los diferentes parámetros de programación del TENS deben ajustarse teniendo en cuenta que las diferentes posibilidades de programación van a activar diferentes mecanismos fisiológicos. En los últimos tiempos, se han venido realizando importantes estudios con animales y en sujetos sanos, con el fin de dilucidar qué efectos fisiológicos son los que se producen en el organismo al aplicarse TENS. Material y métodos. Se llevó a cabo una revisión exhaustiva de la literatura científica publicada sobre la utilización de la técnica TENS y sus efectos fisiológicos. Los estudios relevantes fueron identificados a través de una búsqueda en las diversas bases de datos, así como de libros de referencia en la materia, procedentes de la Biblioteca de la Universidad CEU-Cardenal Herrera de Valencia. Resultados. Se localizaron 97 referencias que cumplieron con los criterios de inclusión. Conclusiones. El TENS produce su efecto analgésico por la activación de las aferencias de los tejidos profundos por estimulación de las fibras aferentes primarias de gran diámetro ABeta. Los mecanismos de acción fisiológicos del TENS de alta y baja frecuencia son distintos, aunque ambos se producen a nivel periférico, espinal y supraespinal, y se basan primordialmente en la activación de distintos receptores opioides. Con la combinación de parámetros adecuada, el TENS reduce el dolor desde el primer minuto de aplicación. Respecto a la duración del efecto analgésico tras una sesión de tratamiento, se ha demostrado la importancia de emplear intensidades elevadas para conseguir una mayor duración del efecto postsesión. La aplicación repetida diariamente de TENS con los mismos parámetros produce el desarrollo de tolerancia. Aunque se ha especulado respecto a un efecto vascular de la aplicación de TENS, éste sólo tiene efecto sobre la circulación periférica aplicado a una intensidad suficiente para conseguir contracciones musculares importantes; en todo caso, el efecto es local sobre la zona de aplicación. La aplicación de TENS puede influir positivamente en la actividad muscular de pacientes con déficits motores en accidentes cerebrovasculares y otros desórdenes neurológicos (AU)

Purpose. To analyze the physiological effects of the application of the transcutaneous electrical nerve stimulation (TENS) technique on patients, to provide guidance for successful implementation in clinical practice. TENS technique involves the application of a pulsed electric current, traditionally used for pain control. Different TENS programming parameters should be adjusted, taking into account that the different programming options will activate various physiological mechanisms. Extensive studies in animals and in healthy subjects have been conducted recently, in order to elucidate the physiological effects produced in the body when TENS is applied. Material and methods. We conducted a comprehensive review of published scientific literature on the use of the TENS technique and its physiological effects. Relevant trials were identified through a search of various databases and reference books on the subject, from the Library of the CEU-Cardenal Herrera University of Valencia. Results. We found 97 references that met the inclusion criteria. Conclusions. TENS produces its analgesic effect by activation of afferents of deep tissues by stimulation of primary ABeta large diameter afferent fibers. The physiological mechanisms of action of TENS at low and high frequency are different, although both occur at peripheral, spinal and supraspinal level, and are based primarily on the activation of different opioid receptors. With the proper combination of parameters, TENS reduces pain from the first minute of application. Regarding the duration of analgesic effect after a treatment session, it is known the importance of using higher intensities for greater duration of post-session effect. The daily repeated application of TENS with the same parameters will lead to the development of tolerance. Although there has been speculation about a vascular effect of the application of TENS, it only has an effect on peripheral circulation when applied at intensity sufficient to achieve significant muscle contractions; in any case the effect is reduced in the area of application. The application of TENS can positively influence muscle activity in patients with motor deficits in stroke and other neurological disorders (AU)