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经外耳皮肤电刺激迷走神经对脑梗死偏瘫患者上肢运动功能恢复的影响
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注册号:

Registration number:

ChiCTR1800019635 

最近更新日期:

Date of Last Refreshed on:

2018-11-20 

注册时间:

Date of Registration:

2018-11-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

经外耳皮肤电刺激迷走神经对脑梗死偏瘫患者上肢运动功能恢复的影响 

Public title:

Effect of transcutaneous vagus nerve stimulation on the recovery of upper limb motor function in patients with ischemic stroke 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

经外耳皮肤电刺激迷走神经对脑梗死偏瘫患者上肢运动功能恢复的影响 

Scientific title:

Effect of transcutaneous vagus nerve stimulation on the recovery of upper limb motor function in patients with ischemic stroke 

研究课题代号(代码):

Study subject ID:

重庆市科卫联合医学科研重点项目(2018ZDXM022)、重庆市科卫联合医学科研面上项目(2018MSXM043) 

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:

贾功伟 

研究负责人:

贾功伟 

Applicant:

Gongwei Jia 

Study leader:

Gongwei Jia 

申请注册联系人电话:

Applicant telephone:

+86 023-63693075 

研究负责人电话:

Study leader's telephone:

+86 023-63693075 

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:

jiagongwei@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jiagongwei@163.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:

重庆市渝中区临江路74号 

研究负责人通讯地址:

重庆市渝中区临江路74号 

Applicant address:

74 Linjiang Road, Yuzhong District, Chongqing, China 

Study leader's address:

74 Linjiang Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

重庆医科大学附属第二医院 

Applicant's institution:

The Second Affiliated Hospital of Chongqing Medical University 

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:

(2018)208 

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:

重庆医科大学附属第二医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

吴明珍 

Contact Name of the ethic committee:

Mingzhen Wu 

伦理委员会联系地址:

重庆市渝中区临江路74号 

Contact Address of the ethic committee:

74 Linjiang Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区临江路74号 

Primary sponsor's address:

74 Linjiang Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属第二医院

具体地址:

重庆市渝中区临江路74号

Institution
hospital:

The Second Affiliated Hospital of Chongqing Medical University

Address:

74 Linjiang Road, Yuzhong District, Chongqing, China

经费或物资来源:

重庆市科卫联合医学科研重点项目(2018ZDXM022)、重庆市科卫联合医学科研面上项目(2018MSXM043) 

Source(s) of funding:

Chongqing Science Committee and Health Committee Joint Medical Research Project (2018ZDXM022, 2018MSXM043) 

研究疾病:

脑梗死 

Target disease:

ischemic stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

经外耳皮肤电刺激迷走神经对脑梗死偏瘫患者上肢运动功能恢复治疗作用的安全性、有效性。 

Objectives of Study:

To investigate the effects of transcutaneous vagus nerve stimulation (t-VNS) on upper limb motor function in patients with ischemic stroke.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①首发发病且发病在3月内的脑梗死。 ②诊断符合全国第四届脑血管病学术会议修订的诊断标准并经头颅CT或MRI证实。 ③既往肢体活动正常,入院存在不同程度的偏瘫。 ④生命体征平稳,无意识障碍。 ⑤能够遵医嘱服用脑梗死二级预防药物及配合常规康复训练的患者。 ⑥同意参与本试验者。 

Inclusion criteria

1. Cerebral infarction with a first onset and onset within 3 months; 2. The diagnosis was in accordance with the revised diagnostic criteria of the Fourth National Conference on Cerebrovascular Diseases and confirmed by head CT or MRI; 3. The previous physical activity was normal, and there were different degrees of hemiplegia in admission; 4. Vital signs are stable and unconscious; 5. can take the secondary prevention drugs for cerebral infarction and patients with routine rehabilitation training; 6 agree to participate in the trial. 

排除标准:

①出血性脑梗死、腔隙性脑梗死。 ②严重的心、肺、肝、肾功能不全及血液系统疾病。 ③恶性肿瘤或各种感染性疾病。 ④存在骨关节系统等疾病影响肌力评定的患者。 ⑤无法配合康复评定的患者。 

Exclusion criteria:

1. hemorrhagic cerebral infarction, lacunar infarction; 2. severe heart, lung, liver, kidney dysfunction and blood system diseases; 3. malignant tumors or various infectious diseases; 4. Patients with bone and joint system and other diseases affect muscle strength assessment; 5. patients who cannot be combined with rehabilitation assessment. 

研究实施时间:

Study execute time:

From2018-12-01To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2018-12-01To 2019-11-30 

干预措施:

Interventions:

组别:

外耳皮肤电刺激迷走神经组

样本量:

40

Group:

Group 1

Sample size:

干预措施:

经外耳皮肤电刺激迷走神经

干预措施代码:

Intervention:

t-VNS

Intervention code:

组别:

假刺激组

样本量:

40

Group:

Group 2

Sample size:

干预措施:

假刺激

干预措施代码:

Intervention:

sham t-VNS

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Second Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

上肢Fugl-Meyer评分

指标类型:

主要指标 

Outcome:

Upper limb Fugl-Meyer score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

上肢运动力指数

指标类型:

主要指标 

Outcome:

motricity 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:

偏瘫上肢功能测试(香港版)

指标类型:

主要指标 

Outcome:

Hong Kong edition of functional test for the hemiplegic upper extremity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主动腕背伸活动度

指标类型:

主要指标 

Outcome:

active range of motion

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:

组织:

Sample Name:

NO

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

随机数字表

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

random number table

盲法:

未说明

Blinding:

Not stated

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):

文章

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

article

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:

病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-11-20
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