应用 DTI 及 DTT 技术探讨调任通督针法治疗脑梗塞的功能恢复机制研究

注册号:

Registration number:

AMCTR-OPC-20000339 

注册号获得时间:

Date of releasing the registration number:

2020/6/1 11:27:02 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

应用 DTI 及 DTT 技术探讨调任通督针法治疗脑梗塞的功能恢复机制研究 

Public title:

Study on the mechanism of functional recovery of cerebral infarction treated with DTI and DTT technique 

研究课题的正式科学名称:

应用 DTI 及 DTT 技术探讨调任通督针法治疗脑梗塞的功能恢复机制研究 

Scientific title:

Study on the mechanism of functional recovery of cerebral infarction treated with DTI and DTT technique 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

杨福霞 

研究负责人:

杨福霞 

Applicant:

yangfuxia 

Study leader:

yangfuxia 

申请注册联系人电话:

Applicant telephone:

13828868511 

研究负责人电话:

Study leader's telephone:

13828868511 

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:

535050185@139.com 

研究负责人电子邮件:

Study leader's E-mail:

535050185@139.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:

广东省深圳市福田区福华路1号 

研究负责人通讯地址:

广东省深圳市福田区福华路1号 

Applicant address:

1 Fuhua Road, Futian District, Shenzhen, Guangdong, China 

Study leader's address:

1 Fuhua Road, Futian District, Shenzhen, Guangdong, 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:

深圳市中医院 

Applicant's institution:

深圳市中医院 

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:

K2019-019-01 

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:

广州市中医药大学第四临床医学院(深圳市中医院)医学伦理委员会 

Name of the ethic committee:

The ethic committee of Shenzhen Traditional Chinese Medicine Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-26 

研究实施负责(组长)单位:

深圳市中医院 

Primary sponsor:

Shenzhen Traditional Chinese Medicine Hospital 

研究实施负责(组长)单位地址:

福华路1号 

Primary sponsor's address:

Shenzhen Traditional Chinese Medicine Hospital 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

shenzhen

单位(医院):

深圳市中医院

具体地址:

广东省深圳市福田区福华路1号

Institution
hospital:

Shenzhen Traditional Chinese Medicine hospital

Address:

1 Fuhua Road, Futian District, Shenzhen, Guangdong, China

经费或物资来源:

广东省自然科学基金 

Source(s) of funding:

The Natural Science Foundation of Guangdong Province 

研究疾病:

脑梗塞 

Target disease:

cerebral infarction 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

应用DTI及DTT技术评价调任通督针法治疗脑梗死后的临床疗效具有可行性。应用DTI及DTT技术对针灸治疗脑梗死后功能恢复机制研究具有可行性和应用价值。 

Objectives of Study:

The DTI and DTT techniques were used to evaluate the clinical efficacy of transfer-to-supervision acupuncture in treating cerebral infarction. The application of DTI and DTT techniques in the treatment of post-infarction functional recovery mechanism of acupuncture and moxibustion of cerebral infarction. 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

符合1995年第四次脑血管病学术会议修订的《各类脑血管疾病诊断要点》关于脑梗死的诊断标准[][]中华医学会第四届全国脑血管病学术会议.各项脑血管病诊断要点[J].中华神经内科杂志,1996,29(6):379.,并经CT或MR确诊为脑梗死;18岁≦发病年龄≦80岁;21天≦发病时间≦90天;理解力基本正常,能够配合检查和治疗意识清醒;初次发病或既往发作但未遗留神经功能障碍;病灶病变部位基本相同,位于基底节区、侧脑室旁、半卵圆中心或脑桥且均累及了白质区,有不同程度的肢体运动功能障碍;患者知情,并能配合治疗、检查及随访。 

Inclusion criteria

In accordance with the 1995 Fourth Cerebrovascular Disease Academic Conference revised "all kinds of cerebrovascular disease diagnosis points" on the diagnostic criteria of cerebral infarction [][] the fourth Chinese Medical Association National Cerebrovascular Disease Academic Conference. Diagnostic essentials of cerebrovascular diseases [J].] The Chinese Journal of Neurology ,1996,29(6):379. The patient was diagnosed with cerebral infarction by CT or MR; the age of onset ≦18 years old was 80 years old; the time of onset ≦21 days was 90 days; the understanding was basically normal, the patient was able to cooperate with the examination and treatment of conscious consciousness; the initial onset or previous attack but not left neurological dysfunction; the location of the lesion was basically the same, It is located in basal ganglia, lateral ventricle, center of semicircle or pontine all involved the white matter area, with varying degrees of limb motor dysfunction; the patient was informed and could cooperate with treatment, examination and follow-up. 

排除标准:

不符合上述诊断标准和纳入标准者;年龄在18周岁以下,或者80周岁以上;病前有引起感觉运动缺损的卒中、脊髓病变、精神病及其他神经系统疾病史;排除外伤、颅内肿瘤和感染、脑脱髓鞘病变、严重心肺肝肾功能不全及其他原因导致肢体、器官残缺或者畸形;有MRI检查禁忌症,包括:体内金属假牙、金属支架、人工关节等;妊娠及哺乳期妇女;依从性差、不能配合者。 

Exclusion criteria:

Failure to meet the above diagnostic criteria and inclusion criteria; age under 18 years of age or above 80 years of age; history of stroke, myelopathy, psychosis and other neurological diseases causing sensorimotor defects prior to illness; exclusion of trauma, intracranial tumors and infections, demyelinating lesions of the brain, severe heart, lung, liver and kidney dysfunction and other causes leading to limb, organ defects or malformations; contraindications for MRI examination, including: internal metal dentures, metal stents, artificial joints, etc.; pregnant and lactating women; poor compliance, uncooperative. 

研究实施时间:

Study execute time:

From2018-05-01To 2021-04-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

30

Group:

treatment group

Sample size:

干预措施:

调任通督针法

干预措施代码:

Intervention:

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

shenzhen 

单位(医院):

深圳市中医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

各向异性分数值

指标类型:

主要指标 

Outcome:

fractional anisotropy(FA)

Type:

Primary indicator 

指标中文名:

皮质脊髓束损伤评分

指标类型:

主要指标 

Outcome:

Damage score of CST(corticospinal tract)

Type:

Primary indicator 

指标中文名:

量表

指标类型:

主要指标 

Outcome:

scale

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No Sample

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

随机方法(请说明由何人用什么方法产生随机序列):

性别:

男女均可

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

no

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

Resman临床试验公共管理平台

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

Resman Clinical Trial Management Public Platform

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):

1. 研究数据:病例记录 2.数据库:Excel、DTI及DTT数据

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

1. study data: case record 2. Database: Excel、DTI and DTT data

创建人:

Creater Name:

 2020-05-16
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