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儿童和青少年正常人群外周神经和神经根的超声参考值:一项观察性前瞻性试验的研究方案

Ultrasonographic reference values for peripheral nerves and nerve roots in the normal population of children and adolescents: study protocol for an observational-prospective trial.

作者信息

Rasenack Maria, Décard Bernhard F, Schädelin Sabine, Grimm Alexander, Fischer Dirk, Hafner Patricia

机构信息

Department of Neurology, Basel University Hospital, Basel, Switzerland.

Clinical Trial Unit, Basel University Hospital, Basel, Switzerland.

出版信息

BMJ Open. 2016 Dec 9;6(12):e014662. doi: 10.1136/bmjopen-2016-014662.

Abstract

BACKGROUND

High-resolution ultrasonography is a new and promising technique to evaluate peripheral and spinal nerves. Its validity as a diagnostic tool in neurological diseases has been demonstrated in adults. Up to now no reference values have been published in children and adolescents although this technique would be ideal in this population as it is fast and non-invasive.

METHODS/DESIGN: Our aim is to generate ultrasonographic reference values for several peripheral nerves (median, ulnar, radial, tibial, sural, peroneal and tibial nerve) as well as for the spinal nerves C5 and C6 and the vagus nerve in children and adolescents. In an observational prospective study, we will recruit 205 children and adolescents aged between ≥2 and ≤18 years without neuromuscular symptoms/signs and without a history of neuromuscular disease. After the collection of demographic and anthropometric data (height, weight, body mass index, age, gender and handedness) and a neurologic examination, a high-resolution ultrasonography of peripheral and spinal nerves at several anatomic landmarks will be performed. These data will be used to estimate age-dependent percentile curves and to evaluate inter-rater, intrarater and interequipment reliability of the measurements.

ETHICS AND DISSEMINATION

This study was approved by the local ethics committee (EKNZ 2015-210). The findings from this study will be disseminated through peer-reviewed publications and conference presentations.

TRIAL REGISTRATION NUMBER

NCT02570802, pre-results publication.

摘要

背景

高分辨率超声检查是一种评估周围神经和脊神经的新型且有前景的技术。其作为神经系统疾病诊断工具在成人中的有效性已得到证实。尽管该技术快速且无创,非常适合儿童和青少年群体,但目前尚未发表关于儿童和青少年的参考值。

方法/设计:我们的目标是生成儿童和青少年几条周围神经(正中神经、尺神经、桡神经、胫神经、腓肠神经、腓总神经和胫神经)以及脊神经C5和C6和迷走神经的超声参考值。在一项观察性前瞻性研究中,我们将招募205名年龄在≥2岁至≤18岁之间、无神经肌肉症状/体征且无神经肌肉疾病病史的儿童和青少年。在收集人口统计学和人体测量学数据(身高、体重、体重指数、年龄、性别和利手)以及进行神经学检查后,将在几个解剖标志处对周围神经和脊神经进行高分辨率超声检查。这些数据将用于估计年龄相关的百分位数曲线,并评估测量的评分者间、评分者内和设备间可靠性。

伦理与传播

本研究已获得当地伦理委员会批准(EKNZ 2015 - 210)。本研究的结果将通过同行评审出版物和会议报告进行传播。

试验注册号

NCT02570802,预结果发表。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46dc/5168681/b9e7eec950d0/bmjopen2016014662f01.jpg

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