今天是:2022-08-12 星期五

基于复杂脑网络技术探讨头针对脑功能重塑的价值
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注册号:

Registration number:

ChiCTR2200061890 

最近更新日期:

Date of Last Refreshed on:

2022-07-06 

注册时间:

Date of Registration:

2022-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于复杂脑网络技术探讨头针对脑功能重塑的价值 

Public title:

Exploring the value of scalp acupuncture for brain function remodeling based on complex brain network technology 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于复杂脑网络技术探讨头针对脑功能重塑的价值 

Scientific title:

Exploring the value of scalp acupuncture for brain function remodeling based on complex brain network technology 

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:

王远青 

研究负责人:

王远青 

Applicant:

Yuanqing Wang 

Study leader:

Yuanqing Wang 

申请注册联系人电话:

Applicant telephone:

15006335102 

研究负责人电话:

Study leader's telephone:

15006335102 

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:

wyuanqing121@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wyuanqing121@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:

曲阜师范大学日照校区 

研究负责人通讯地址:

曲阜师范大学日照校区 

Applicant address:

Rizhao Campus of Qufu Normal University 

Study leader's address:

Rizhao Campus of Qufu Normal University 

申请注册联系人邮政编码:

Applicant postcode:

276800 

研究负责人邮政编码:

Study leader's postcode:

276800 

申请人所在单位:

山东省日照市人民医院 

Applicant's institution:

Shandong Rizhao People's 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:

2021-伦理意见-KY-38-02 

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:

山东省日照市人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of People's Hospital of Rizhao City, Shandong Province 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

马项雨 

Contact Name of the ethic committee:

Xiangyu Ma 

伦理委员会联系地址:

山东省日照市泰安路126号 

Contact Address of the ethic committee:

No. 126, Tai'an Road, Rizhao City, Shandong Province 

伦理委员会联系人电话:

Contact phone of the ethic committee:

15006335102 

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:

山东省日照市人民医院 

Primary sponsor:

Shandong Rizhao People's Hospital 

研究实施负责(组长)单位地址:

山东省日照市泰安路126号 

Primary sponsor's address:

No. 126, Tai'an Road, Rizhao City, Shandong Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东省

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

山东省日照市人民医院

具体地址:

山东省日照市泰安路126号

Institution
hospital:

Shandong Rizhao People's Hospital

Address:

No. 126, Tai'an Road, Rizhao City, Shandong Province

经费或物资来源:

山东省中医药科技项目 

Source(s) of funding:

Shandong Province Traditional Chinese Medicine Science and Technology Project 

研究疾病:

中风 

Target disease:

stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

运用功能磁共振技术和复杂脑网络技术相结合,初步揭示脑运动功能重塑过程中的神经网络变化特点以及头针对脑功能重塑的作用位点。 

Objectives of Study:

Using the combination of fMRI technology and complex brain network technology, we initially revealed the characteristics of neural network changes in the process of brain motor function remodeling and the action sites of head-to-brain function remodeling. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)年龄45-70岁。(2)辨证分型:风痰瘀阻、气虚络瘀、肝肾亏虚。(3)签署知情同意。 

Inclusion criteria

(1) Age 45-70 years old. (2) Syndrome classification: wind-phlegm stasis, qi deficiency and collateral stasis, liver and kidney deficiency. (3) Sign informed consent. 

排除标准:

(1)肝炎、结核、肺炎等感染性疾病。(2)已接受相关治疗并可能影响效应观测指标。(3)伴有可能影响效应指标观测、判断的其他生理或病理状况。(4)严重心、肝、肾损害影响药物代谢。(5)心脏安装起搏器、支架、搭桥术后或其它不能进行磁共振检查者。(6)特殊人群( 孕妇和 哺乳期妇女、精神病、病情危笃或疾病晚期) 

Exclusion criteria:

(1) Infectious diseases such as hepatitis, tuberculosis, pneumonia, etc. (2) Relevant treatment has been received and may affect the observation indicators of the effect. (3) Associated with other physiological or pathological conditions that may affect the observation and judgment of effect indicators. (4) Severe heart, liver and kidney damage affects drug metabolism. (5) Those who have a pacemaker, stent, bypass surgery or other patients who cannot undergo magnetic resonance examination. (6) Special populations (pregnant women and lactating women, mentally ill, critically ill or terminally ill) 

研究实施时间:

Study execute time:

From2022-07-06To 2023-07-06 

征募观察对象时间:

Recruiting time:

From2022-07-06To 2023-07-06 

干预措施:

Interventions:

组别:

Case series

样本量:

76

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东省 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东省日照市人民医院 

单位级别:

三甲 

Institution
hospital:

Shandong Rizhao People's Hospital  

Level of the institution:

Class III A 

测量指标:

Outcomes:

指标中文名:

改良Rankin量表

指标类型:

主要指标 

Outcome:

mRS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

美国国立研究院评定量表

指标类型:

主要指标 

Outcome:

NIHSS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易智力状态检查量表

指标类型:

次要指标 

Outcome:

MMSE

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数

指标类型:

附加指标 

Outcome:

PSQI

Type:

Additional 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:

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 45 years
最大 Max age 70 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):

不涉及随机分组

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

not involving

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否No

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):

不共享

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

do not share

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:

不共享

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

do not share

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-07-06
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