BackgroundAlthough the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or... Show moreBackgroundAlthough the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or preventive treatment of migraine, the Clinical Trials Committee of the International Headache Society has not developed guidelines specifically for clinical trials of neuromodulation devices. In recognition of the distinct needs and challenges associated with their assessment in controlled trials, the Committee provides these recommendations for optimizing the design and conduct of controlled trials of neuromodulation devices for the acute and/or preventive treatment of migraine.MethodsAn international group of headache scientists and clinicians with expertise in neuromodulation evaluated clinical trials involving neuromodulation devices that have been published since 2000. The Clinical Trials Committee incorporated findings from this expert analysis into a new guideline for clinical trials of neuromodulation devices for the treatment of migraine.ResultsKey terms were defined and recommendations provided relative to the assessment of neuromodulation devices for acute treatment in adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created.ConclusionsAdoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment. Show less
Recent technological advances in echocardiography, with progressive miniaturization of ultrasound machines, have led to the development of handheld ultrasound devices (HUD). These devices, no... Show moreRecent technological advances in echocardiography, with progressive miniaturization of ultrasound machines, have led to the development of handheld ultrasound devices (HUD). These devices, no larger than some mobile phones, can be used to perform partial, focused exams as an extension to the physical examination. The European Association of Cardiovascular Imaging (EACVI) acknowledges that the dissemination of appropriate HUD use is inevitable and desirable, because of its potential impact on patient management. However, as a scientific society of cardiac imaging, our role is to provide guidance in order to optimize patient benefit and minimize drawbacks from inappropriate use of this technology. This document provides updated recommendations for the use of HUD, including nomenclature, appropriateness, indications, operators, clinical environments, data management and storage, educational needs, and training of potential users. It also addresses gaps in evidence, controversial issues, and future technological developments. Show less
