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Facial nerve stimulation in healthy human subjects

机译:健康人类受试者的面神经刺激

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摘要

Stroke affects more than 16 M people worldwide and emergency treatments are available for less than 5% of the patients. Magnetic stimulation of the facial nerve has been tested in pre-clinical studies as a new, non-invasive emergency treatment of ischemic stroke that acts by increasing cerebral blood flow (CBF). The objective of this study in healthy human subjects is to help understand the safety, tolerability, and effectiveness of a clinical prototype facial nerve stimulator as a first step toward clinical studies in ischemic stroke patients. The geniculate ganglion region of the facial nerve was located bilaterally with neuronavigation and then stimulated in 35 healthy subjects. Safety was assessed with adverse event reports and by medical examination in all 35 subjects. Tolerability was defined as each subjects' self-determined ability to withstand at least 2 minutes of stimulation at escalating power levels. MRI perfusion cerebral blood flow (CBF) measurements were available in 31 of the subjects. Stimulation produced a clear (> 25%) increase in CBF in 10 of 31 subjects, and smaller increases in most of the remaining subjects. These results support the development of our device as an emergency ischemic stroke treatment.
机译:中风影响全球超过1600万患者,只有不到5%的患者可以接受紧急治疗。在临床前研究中已经对面神经进行磁刺激进行了测试,它是一种新的,无创性的治疗缺血性中风的紧急治疗方法,可通过增加脑血流量(CBF)起作用。这项针对健康人类受试者的研究的目的是帮助了解临床原型面神经刺激器的安全性,耐受性和有效性,作为针对缺血性中风患者进行临床研究的第一步。面神经的膝状神经节区域通过神经导航在两侧定位,然后在35名健康受试者中受到刺激。通过不良事件报告和所有35位受试者的医学检查评估安全性。耐受性被定义为每个受试者在逐渐增加的力量水平下承受至少2分钟刺激的自我确定的能力。 31位受试者可进行MRI灌注脑血流量(CBF)测量。刺激使31名受试者中的10名的CBF明显增加(> 25%),而其余大多数受试者的CBF升高较小。这些结果支持我们的设备开发为一种紧急缺血性中风的治疗方法。

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