头皮针干预脑卒中后认知功能障碍的复杂脑网络研究

注册号:

Registration number:

AMCTR-IOR-19000246 

注册号获得时间:

Date of releasing the registration number:

2019/1/28 19:00:26 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

头皮针干预脑卒中后认知功能障碍的复杂脑网络研究 

Public title:

Study on the effect of scalp acupuncture on complex network in post-stroke cognitive impairment 

研究课题的正式科学名称:

头皮针干预脑卒中后认知功能障碍的复杂脑网络研究 

Scientific title:

Study on the effect of scalp acupuncture on complex network in post-stroke cognitive impairmentment 

研究课题代号(代码):

Study subject ID:

LGF19H270001 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

刘斐雯 

研究负责人:

刘斐雯 

Applicant:

feiwen liu 

Study leader:

feiwen liu 

申请注册联系人电话:

Applicant telephone:

15990703311 

研究负责人电话:

Study leader's telephone:

15990703311 

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:

feiwen__liu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

feiwen__liu@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.wzszyy.com 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.wzszyy.com 

申请注册联系人通讯地址:

浙江省温州市六虹桥蛟尾路9号 

研究负责人通讯地址:

浙江省温州市六虹桥蛟尾路9号 

Applicant address:

No.9 jiaowei road, liuhongqiao, wenzhou, zhejiang 

Study leader's address:

No.9 jiaowei road, liuhongqiao, wenzhou, zhejiang 

申请注册联系人邮政编码:

Applicant postcode:

325000 

研究负责人邮政编码:

Study leader's postcode:

325000 

申请人所在单位:

温州市中医院 

Applicant's institution:

Wenzhou hospital of Chinese medicine 

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:

WTCM-H-2018030 

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:

温州市中医院伦理委员会 

Name of the ethic committee:

Ethics committee of wenzhou hospital of traditional Chinese medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-07-31 

研究实施负责(组长)单位:

温州市中医院 

Primary sponsor:

Wenzhou hospital of Chinese medicine 

研究实施负责(组长)单位地址:

浙江省温州市六虹桥蛟尾路9号 

Primary sponsor's address:

No.9 jiaowei road, liuhongqiao, wenzhou, zhejiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

温州

Country:

China

Province:

zhejiang

City:

wenzhou

单位(医院):

温州市中医院

具体地址:

浙江省温州市六虹桥蛟尾路9号

Institution
hospital:

Wenzhou hospital of Chinese medicine

Address:

No.9 jiaowei road, liuhongqiao, wenzhou, zhejiang

经费或物资来源:

浙江省自然科学基金基础公益研究计划项目(LGF19H270001) 

Source(s) of funding:

Natural science foundation of zhejiang province(LGF19H270001) 

研究疾病:

脑卒中后认知功能障碍 

Target disease:

post-stroke cognitive impairment 

研究疾病代码:

Target disease code:

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

1. 探讨单次针刺神庭、百会可能的脑功能网络机制 2. 获取针刺改善脑卒中患者认知功能的脑网络影像标记 3. 实现通过脑网络影像标记预测针刺干预后的远期认知康复结局 

Objectives of Study:

1. To explore the possible brain function network mechanism of acupuncture for shenting and baihui 2. To obtain brain network image markers for acupuncture to improve cognitive function in post-stroke cognitive impairment 3. To predict the long-term cognitive rehabilitation outcome after acupuncture through brain network image markers 

研究设计:

随机交叉对照 

Study design:

Randomized cross-over control 

纳入标准:

①本人或法定监护人同意并已签署知情同意书; ②符合“脑卒中”的诊断标准,并经头颅CT或MRI检查证实; ③经简易智能精神状态检查量表筛查小于或等于24分; ④首次脑卒中,病程≤1年; ⑤45岁≤年龄≤75岁; ⑥病情稳定,意识清醒,生命体征稳定。 

Inclusion criteria

1.Signed informed consent himself (herself) or his (her) Legal guardian; 2.Diagnosed with stroke according to the criteria of Diagnostic Criteria and confirmed by CT or MRI; 3.According to the Mini-Mental Status Examination (MMSE) screening: scores no more than 24; 4.The first stroke occurred within one year; 5.Age between 45 and 75 years; 6.The patients should be conscious, with stable vital signs. 

排除标准:

①经检查证实患脑肿瘤等可引起认知功能障碍的其他疾病; ②存在严重言语、视力、听力障碍、精神或情绪障碍等影响认知检查; ③经既往病历或临床医生或家属证实,脑卒中发病前已患有认知障碍的相关疾病或在发病前有使用针对认知障碍的药物; ④合并有严重的心、肝、肾等系统疾病; ⑤有酒精、药物滥用史; ⑥存在磁共振检查的禁忌症; ⑦正在参加影响本研究结果评价的其它试验。 

Exclusion criteria:

1.Patients who suffer from brain tumor or other diseases that could cause cognitive dysfunction; 2.Patients with severe language, vision, auditory, neuropsychiatric or mood disorder precluding cognitive examine; 3.Patients who suffer from diseases related to cognitive impairment confirmed by anamnesis, doctors or families or with history of the cognitive drug before stroke; 4.With serious illnesses, such as heart, liver, kidney, endocrine diseases and hematopoietic system disease; 5.Patients with alcohol or drug abuse; 6.Contraindications for fMRI; 7.Patients who are included in other clinical trials that would affect the evaluation results of this study. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

A组

样本量:

15

Group:

group A

Sample size:

干预措施:

单次头皮针+单次假针+2周头皮针

干预措施代码:

Intervention:

a scalp acupuncture+ a sham acupuncture+scalp acupuncture for 2 weeks

Intervention code:

组别:

B组

样本量:

15

Group:

group B

Sample size:

干预措施:

单次假针+单次头皮针+2周头皮针

干预措施代码:

Intervention:

a sham acupuncture+a scalp acupuncture+scalp acupuncture for 2 weeks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

China 

市(区县):

浙江 

Country:

zhejiang 

Province:

温州 

City:

wenzhou 

单位(医院):

温州市中医院 

单位级别:

Wenzhou hospital of Chinese medicine 

Institution
hospital:

三级甲等  

Level of the institution:

Class a hospital 

测量指标:

Outcomes:

指标中文名:

整体认知功能

指标类型:

主要指标 

Outcome:

Global cognitive function

Type:

Primary indicator 

指标中文名:

脑功能影像学评定

指标类型:

次要指标 

Outcome:

Imaging evaluation of brain function

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

颅脑影像学数据

组织:

Sample Name:

Craniocerebral imaging data

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

负责随机的研究人员采用spss产生随机序列

性别:

男女均可

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

SPSS was used to generate random sequences

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

临床试验公共管理平台ResMan

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

www.medresman.org

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

数据包括原始记录、病例记录表等数据的excel保存,采用ResMan数据库管理。

The repository and management of the data(Please specify what repository will be used for management of the metadata):

The data includes the using excel records of CRF. The ResMan database will be used.

创建人:

Creater Name:

 2019-01-19
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