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基于F波检测的分裂手指数在肌萎缩侧索硬化诊断中的应用研究
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注册号:

Registration number:

ChiCTR1900024520 

最近更新日期:

Date of Last Refreshed on:

2019-07-13 

注册时间:

Date of Registration:

2019-07-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于F波检测的分裂手指数在肌萎缩侧索硬化诊断中的应用研究 

Public title:

Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于F波检测的分裂手指数在肌萎缩侧索硬化诊断中的应用研究 

Scientific title:

Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

王志丽 

研究负责人:

崔丽英 

Applicant:

Zhi-li Wang 

Study leader:

Liying Cui 

申请注册联系人电话:

Applicant telephone:

+86 010 69151371 

研究负责人电话:

Study leader's telephone:

+86 010 69151371 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

WZL778877@163.com 

研究负责人电子邮件:

Study leader's E-mail:

pumchcuily@yahoo.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市东城区帅府园1号 

研究负责人通讯地址:

北京市东城区帅府园1号 

Applicant address:

1 Shuaifuyuan, Dongcheng District, Beijing, China 

Study leader's address:

1 Shuaifuyuan, Dongcheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100730 

研究负责人邮政编码:

Study leader's postcode:

100730 

申请人所在单位:

北京协和医院 

Applicant's institution:

Peking Union Medical College Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

JS-2004 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

北京协和医院伦理委员会 

Name of the ethic committee:

Peking Union Medical College Hospital Clinical Research Ethics Committee (Beijing, China) 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-21 

伦理委员会联系人:

朱以诚 

Contact Name of the ethic committee:

Yicheng Zhu 

伦理委员会联系地址:

北京市东城区帅府园1号 

Contact Address of the ethic committee:

Peking Union Medical College Hospital (Dongdan campus), 1 Shuaifuyuan, Dongcheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

北京协和医院 

Primary sponsor:

Peking Union Medical College Hospita 

研究实施负责(组长)单位地址:

北京市东城区帅府园1号 

Primary sponsor's address:

1 Shuaifuyuan, Dongcheng District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京协和医院

具体地址:

北京市东城区帅府园1号

Institution
hospital:

Peking Union Medical College Hospital

Address:

1 Shuaifuyuan, Dongcheng District, Beijing, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

肌萎缩侧索硬化 

Target disease:

Amyotrophic lateral sclerosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究旨在比较ALS患者和非ALS患者APB、FDI和ADM记录的F波参数变化模式,确定F波计算的分裂手指数诊断ALS的准确性,建立相应的神经生理学生物标志物。 

Objectives of Study:

The aim of the present study was to compare the pattern of F-wave parametes of the APB,FDI,and ADM as well as to elucidate the diagnostic accuracy of the split-hand index calculated by F-wave test and found the diagnostic markers. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

① 年龄:18-80岁; ② 有上肢受累,表现出临床神经、肌肉疾病症状(肌肉无力、萎缩、活动障碍/不灵活、束颤、感觉异常、疼痛、麻木)的患者。 ③受试者阅读并充分理解患者知情同意书,并签署知情同意书。 

Inclusion criteria

(1) Male and Female, aged from 18 to 80 years; (2) Patients with clinical nueromuscular features affecting the upper limbs,ie.,weakenss,atrophy,movement disorder,paraesthesia,pain,numb; (3) The subjects read and fully understands the instructions of the patients and sign the infromed consent. 

排除标准:

① 上肢没有表现出神经肌肉病症状的患者; ② CMAP波无法引出者(APB/ADM/FDI任一肌肉); ③ 既往有颈椎手术史、腕管/肘管手术史; ④ 患者或家属无法理解本研究的条件和目标,不愿意配合者。 

Exclusion criteria:

(1) Patients without clinical neuromuscular features affecting the upper limbs; (2) Patients who had a history of cervial vertebra surgery,carpal tunnel realease surgery treatment for cubital tunnel syndrome; (3) Patients or their family members cannot understand the objectives of this study and are unwilling to cooperate. 

研究实施时间:

Study execute time:

From2019-07-22To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2019-07-22To 2020-02-29 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局:2008版Awaji-Shima诊断标准

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome meet the Awaji-Shima Criteria 2008

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

分裂手指数

Index test:

Split-hand index calculated by F-wave test

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

肌萎缩侧索硬化患者

例数:

Sample size:

300

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Amyotrophic lateral sclerosis

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

有上肢受累,表现出临床神经、肌肉疾病症状(肌肉无力、萎缩、活动障碍/不灵活)的患者

例数:

Sample size:

50

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Patients with clinical nueromuscular features affecting the upper limbs,ie.,weakenss,atrophy,movement disorder;

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京协和医院 

单位级别:

三甲医院 

Institution
hospital:

Peking Union Medical College Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

分裂手指数

指标类型:

主要指标 

Outcome:

Split-hand index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SPE, SEN, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SPE, SEN, ACC, AUC of ROC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

神经电生理指标

组织:

Sample Name:

Neurophysiological parameters

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不随机

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

Blinding:

N/A

是否共享原始数据:

IPD sharing

是Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

试验完成后以文章发表的形式公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Published in the form of an article after the completion of the trial

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

采用Excel保存数据;SPSS软件分析数据;

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The data will be managed by Excel and analyzed by the software SPSS.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-13
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