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基于多模态信息的针刺治疗中风后抑郁效应评价
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注册号:

Registration number:

ChiCTR1800014434 

最近更新日期:

Date of Last Refreshed on:

2018-01-13 

注册时间:

Date of Registration:

2018-01-13 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

基于多模态信息的针刺治疗中风后抑郁效应评价 

Public title:

Evaluation for effect of acupuncture on post-stroke depression based on multimodal information 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于多模态信息的针刺治疗中风后抑郁效应评价 

Scientific title:

Evaluation for effect of acupuncture on post-stroke depression based on multimodal information 

研究课题代号(代码):

Study subject ID:

国家自然科学基金项目(81460273) 

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:

陈洪波 

研究负责人:

胡跃强 

Applicant:

Hongbo Chen 

Study leader:

Yueqiang Hu 

申请注册联系人电话:

Applicant telephone:

+86 15295991158 

研究负责人电话:

Study leader's telephone:

+86 15295991158 

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:

hongbochen@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shitousay1111@tom.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:

广西桂林市金鸡路1号 

研究负责人通讯地址:

广西南宁东葛路89-9号 

Applicant address:

1 Jinji Road, Guilin, Guangxi Zhuang Autonomous Region, China 

Study leader's address:

89-9 Dongge Road, Nanning, Guangxi Zhuang Autonomous Region, China 

申请注册联系人邮政编码:

Applicant postcode:

541004 

研究负责人邮政编码:

Study leader's postcode:

530023 

申请人所在单位:

桂林电子科技大学 

Applicant's institution:

Guilin University of Electronic Technology 

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:

伦审[2014]-024 

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:

广西中医药大学附属第一医院医学伦理委员会 

Name of the ethic committee:

IEC for the The First Affiliated Hospital of Guangxi University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-12-17 

伦理委员会联系人:

黄彬 

Contact Name of the ethic committee:

Bin Huang 

伦理委员会联系地址:

广西南宁东葛路89-9号 

Contact Address of the ethic committee:

89-9 Dongge Road, Nanning, Guangxi Zhuang Autonomous Region, 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:

桂林电子科技大学 

Primary sponsor:

Guilin University of Electronic Technology 

研究实施负责(组长)单位地址:

广西桂林市金鸡路1号 

Primary sponsor's address:

1 Jinji Road, Guilin, Guangxi Zhuang Autonomous Region, 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):

广西壮族自治区

市(区县):

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

单位(医院):

桂林电子科技大学

具体地址:

广西桂林市金鸡路1号

Institution
hospital:

Guilin University of Electronic Technology

Address:

1 Jinji Road, Guilin, Guangxi

国家:

中国

省(直辖市):

广西壮族自治区

市(区县):

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

单位(医院):

广西中医药大学

具体地址:

广西南宁东葛路89-9号

Institution
hospital:

Guangxi University of Chinese Medicine

Address:

89-9 Dongge Road, Nanning, Guangxi

国家:

中国

省(直辖市):

广西壮族自治区

市(区县):

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

单位(医院):

广西江滨医院

具体地址:

广西南宁河堤路85号

Institution
hospital:

Guangxi Jiangbin Hospital

Address:

85 Hedi Road, Nanning, Guangxi

经费或物资来源:

国家自然科学基金项目(81460273) 

Source(s) of funding:

the National Natural Science Foundation of China (81460273) 

研究疾病:

中风后抑郁 

Target disease:

post-stroke depression 

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:

其它 

Study phase:

Other 

研究目的:

中风后抑郁(PSD)是中风病人常见的并发症许多医生是采取针刺手段治疗PSD症然而针刺在该治疗过程中的作用与效应并不明确本项目拟采取静息态fMRI方法,工程技术与医学临床紧密结合,力求揭示针刺治疗PSD的效应和作用机制,为验证针灸治疗神经性疾病疗效提供一种标准的评估方法。 

Objectives of Study:

Post-stroke depression (PSD) is a common complication with stroke. Many doctors have attempted to use acupuncture to treat PSD. However, the role and effect of acupuncture treatment is not clear. This project intends to reveal the effect and mechanism of acupuncture treatment of PSD and provide a standard assessment method for verifying the efficacy of acupuncture in treating neurological diseases, using the resting state fMRI method based on closely integrate the engineering technology with clinical medicine. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机交叉对照 

Study design:

Randomized cross-over control 

纳入标准:

诊断标准:目前尚无单独的中风后抑郁(PSD)的诊断标准,主要参考抑郁症的诊断标准,但应以中风的病史为前提。 中风病诊断标准:中医诊断标准采用国家中医药管理局脑病急症协作组起草制订的《中风病诊断疗效评定标准》(试行);西医诊断标准参照1995年中华医学会第四次全国脑血管病学术会议修订的《各类脑血管疾病诊断要点》。 抑郁症诊断标准:中医诊断标准参照国家中医管理局1995年公布实施的中华人民共和国中医药行业标准《中医病证诊断疗效标准》中规定的郁证的诊断。西医诊断标准参照中华精神科学学术委员会颁布的《中国精神疾病分类与诊断标准》第三版(CCMD-3)中的诊断标准。 入选标准:(1)符合上述诊断标准;(2)患者年龄40-75岁,男女不限;(3)初次卒中的患者,抑郁继发于脑血管疾病急性发作2周以后;(4)符合抑郁诊断的轻、中度抑郁症患者;(5)病情平稳,意识清楚,检查合作,有一定表达及沟通能力;(6)患者自愿参加本项研究,并签署知情同意书; (7)卒中部位为大脑左侧前循环(顶叶、额叶和颞叶),不跨脑区。同时符合上述七项标准者,方可入选。 

Inclusion criteria

1. Patients who meet the above diagnostic criteria; 2. Patients aged 40-75 years, both men and women; 3. Patients with primary stroke and depression occurs in 2 weeks after the acute attack of cerebrovascular disease; 4. Mild and moderate depression; 5. Patients with stable conditions and clear awareness and can cooperate with examination, and have the certain ability of expression and communication; 6. Patients volunteered to participate in this study and signed informed consent; 7. The location of stroke is the left anterior cerebral circulation (parietal lobe, frontal lobe and temporal lobe), which does not across the brain. Those who meet the above seven standards can be selected.  

排除标准:

排除标准:具有下列之一者不可纳入临床试验。(1)不符合入选标准者;(2)卒中发病前有精神疾患或抑郁病史者;(3)近一个月内曾进行抗抑郁治疗者;(4)针刺选穴部位有瘢痕、感染或颜骨缺失者;(5)合并心、脑、肝、肾、造血系统等严重原发性疾病者;妊娠及哺乳期妇女,药物过敏者。 

Exclusion criteria:

(1) Persons who do not meet the inclusion criteria; (2) Those with a history of mental illness or depression before stroke; (3) Those who had prior antidepressant treatment within the past month; (4) Those who have scars, infection or lack of brain structure; (5) Those who suffered from heart, brain, liver, kidney, hematopoietic system and other serious primary diseases; Women in pregnancy and lactation, people who drug allergy. 

研究实施时间:

Study execute time:

From2014-10-01To 2019-12-31 

干预措施:

Interventions:

组别:

针刺治疗组

样本量:

10

Group:

Acupuncture Treatment Group

Sample size:

干预措施:

针刺治疗

干预措施代码:

Intervention:

Acupuncture Intervention

Intervention code:

组别:

对照组

样本量:

10

Group:

Control

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

广西江滨医院 

单位级别:

三甲医院 

Institution
hospital:

Guangxi Jiangbin Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

静息态功能磁共振

指标类型:

附加指标 

Outcome:

Resting-state functional magnetic resonance imaging

Type:

Additional indicator 

测量时间点:

针刺治疗前后

测量方法:

Measure time point of outcome:

before and after acupuncture treatment

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 44 years
最大 Max age 72 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):

由广西江滨医院康复科江文宇主任医师和张延齡医师根据该科室管理的中风且具有抑郁症象的患者中根据纳入标准进行随机选择实验对象和组别。

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

The subjects who participated the test were selected by Prof. Wenyu Jiang and Doctor Yanling Zhang according to the inclusion criteria. Jiang and Zhang work in the Department of Neuro-Rehabilitation in Guangxi Jiangbin Hospital. All subjects were diagnosed as post-stroke depression and randomly divided into the acu

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

实验完成后,所有数据依据要求公开。

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

The test data will be shared to all the peoples according to the requirment.

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:

一、数据采集,在针刺治疗前后,对试验对象均进行静息态fMRI数据采集和HAMD-24项评分记录,对对照组同样进行两次静息态fMRI数据采集和HAMD-24项评分记录,只是两之间不做针刺干预,两次采集的间隔时间为3周。 二、数据管理,实验完成后,所有数据依据要求公开。

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

all PSD participants received the conventional therapy for stroke. The ACT group received the acupuncture intervention for 3 weeks. All ACT participants were followed by rs-fMRI data acquisition and HAMD-24 score records before ACT (bACT) and after ACT (aACT). The participants of CON group did not receive any form of acupuncture intervention and were asked for two rs-fMRI scans and HAMD-24 score records at the first (fCON and second (sCON) observations. The interval between the two data acquisitions was 3 weeks. The test data will be shared to all the peoples according to the requirment.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-01-13
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