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Nerve Conduction Studies as a Measure of Disease Progression: Objectivity or Illusion?

机译:神经传导研究作为疾病进展的衡量标准:客观性或幻觉?

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Background:Clinical nerve conduction studies (NCS) are often used as a secondary outcome measure in therapeutic trials, but show a high degree of inter-trial variability even when technical factors known to affect the recorded responses are minimised. This raises the intriguing possibility that some of the observed variability may reflect true changes in nerve activity. Objectives:Our aim was determine how much variability these factors might produce, and how this might affect the results of commonly used neuropathy rating scales. Methods:A standardised protocol was repeated over forty consecutive trials by the same operators in two healthy subjects. The protocol included recordings that shared either a stimulating or a recording electrode position, such that changes due to electrode position could be excluded, and hand temperature was closely controlled. Results:Despite controlling for inter-operator differences, electrode position, and hand temperature, the variability in sensory nerve action potential (SNAP) amplitude was extremely high (Range 23 μV, CoV?=?10.7–18.8). This variability was greater than the change in amplitude needed to move a subject from point 0 to point 4 on the CMT neuropathy rating scale. Neither temperature or electrode position accounted for all of this variability, suggesting that additional as yet unidentified factors are responsible. Conclusion:Even under closely controlled conditions and sophisticated laboratory methods, test-to-test variability can be significant. The factors responsible for this variability may be difficult to control, limiting the utility of single nerve recordings as a trial outcome measure.
机译:背景:临床神经传导研究(NCS)通常用作治疗试验中的次要结果措施,但即使在已知的影响记录的响应的技术因素最小化时,也显示出高度的试验间变异。这提高了一些观察到的可变性可能反映了神经活动的真实变化的兴趣可能性。目的:我们的目标是确定这些因素可能产生多少变化,以及如何影响常用的神经病评级尺度的结果。方法:在两个健康的科目中由同一运营商重复标准化方案。该协议包括共享刺激或记录电极位置的记录,使得可以排除由于电极位置引起的变化,并且可以密切控制手动温度。结果:尽管控制算子间差异,电极位置和手动温度,但感觉神经动作电位(Snap)振幅的可变性非常高(范围为23μV,CoV?= 10.7-18.8)。这种可变性大于在CMT神经病评级规模上将受试者从0到4点移动到点4所需的幅度所需的变化。既不占所有这些可变性的温度或电极位置都没有占据尚未识别的因素额外的因素。结论:即使在密切控制的条件和复杂的实验室方法中,测试变异性也可能是显着的。负责这种可变性的因素可能难以控制,限制单个神经记录的效用作为试验结果措施。

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