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偏头痛与紧张型头痛认知功能评估的比较研究
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注册号:

Registration number:

ChiCTR1900024307 

最近更新日期:

Date of Last Refreshed on:

2019-07-05 

注册时间:

Date of Registration:

2019-07-05 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

偏头痛与紧张型头痛认知功能评估的比较研究 

Public title:

Cognitive performance in Migraine and Tension-Type Headache: a cross-sectional controlled study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

偏头痛与紧张型头痛认知功能评估的比较研究 

Scientific title:

Cognitive performance in Migraine and Tension-Type Headache: a cross-sectional controlled study 

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:

刘肖 

研究负责人:

肖哲曼 

Applicant:

XIAO LIU 

Study leader:

ZHEMAN XIAO 

申请注册联系人电话:

Applicant telephone:

+86 13026198442 

研究负责人电话:

Study leader's telephone:

+86 13026198442 

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:

akcl.whu@outlook.com 

研究负责人电子邮件:

Study leader's E-mail:

xzman1978@sina.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:

湖北省武汉市武昌区解放路238号 

研究负责人通讯地址:

湖北省武汉市武昌区解放路238号 

Applicant address:

238 Jiefang Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

238 Jiefang Road, Wuchang District, Wuhan, Hubei, 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:

武汉大学人民医院 

Applicant's institution:

Department of Neurology, Renmin Hospital of Wuhan 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:

WDRY2019-K028 

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:

武汉大学人民医院临床研究伦理委员会 

Name of the ethic committee:

the Ethics Committee of Renmin Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

陈红 

Contact Name of the ethic committee:

HONG CHEN 

伦理委员会联系地址:

湖北省武汉市武昌区武汉大学人民医院 

Contact Address of the ethic committee:

Renmin Hospital of Wuhan University, 238 Jiefang Road, Wuhan, Hubei, 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:

武汉大学人民医院 

Primary sponsor:

Renmin hospital of Wuhan university 

研究实施负责(组长)单位地址:

湖北省武汉市武昌区解放路238号 

Primary sponsor's address:

238 Jiefang Road, Wuchang District, Wuhan, Hubei, 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):

湖北省

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

武汉大学人民院

具体地址:

湖北省武汉市武昌区解放路238号

Institution
hospital:

Renmin Hospital of Wuhan University

Address:

238 Jiefang Road, Wuchang District, Wuhan, Hubei, China

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

the National Natural Science Foundation of China 

研究疾病:

偏头痛、紧张型头痛 

Target disease:

Migraine,Tension-Type Headache 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

现存研究发现偏头痛患者可表现出认知功能的减退,然而其他原发性头痛与认知功能的研究并不多见,就此点出发,我们比较研究偏头痛与紧张型头痛对认知功能影响的差异,探寻主要受损的认知域,进一步寻找生物标志物,更好服务于临床。 

Objectives of Study:

Researches have revealed that migraine is often associated with cognitive impairment. There are, however, few studies of Tension-Type Headache (TTH) and cognition. The objective of this study was to compare the cognitive function between migraine and TTH patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

病例组入选标准: ① 明确两次以上头痛发作病史,头痛诊断符合国际头痛疾病分类第三版(ICHD-III beta)的诊断标准; ② 神志清晰,能配合各项检查者,可坚持完成认知量表评定和P300检测; ③ 未接受预防性治疗,或停药至少24小时以上; ④ 受试者和/或监护人知情同意并签署同意书。 正常对照组人选标准: ① 经检查神经系统未见异常; ② 无药物和酒精依赖史,无精神病及精神病家族史等; ③ 知情同意,并签署同意书。 选取与病例组年龄、性别、文化程度等相匹配且符合上述标准的健康志愿者30名,设为对照组。 

Inclusion criteria

Diagnosis of all patients was confirmed based on diagnostic criteria of the International Classification of Headache Disorders (ICHD-3 beta). Patients were not receiving prevention therapy or were medication-free for at least 24 hours when recruited. The control group matched their age, gender and the number of years under an educational program. 

排除标准:

病例组排除标准: ① CT、MRI提示存在大脑器质性改变; ② 合并多种头痛类型; ③ 存在严重的语言功能障碍或(和)听力障碍,不能配合参与量表评定者; ④ 既往大量饮酒或服用可能影响认知功能的药物。 

Exclusion criteria:

Patients were excluded when they had combination of different types of headache, or had alterations in the neuroradiological (MRI), neurophysiological (EEG) or blood chemistry test findings. Participants who were illiterate or suffering from hearing disorders, or communication diseases were not able to cooperate sufficiently to complete the tests, and were therefore excluded. We also excluded those who had history of alcoholism or medications that could affect cognitive function. 

研究实施时间:

Study execute time:

From2018-09-01To 2020-03-01 

征募观察对象时间:

Recruiting time:

From2018-10-01To 2019-07-01 

干预措施:

Interventions:

组别:

偏头痛组

样本量:

30

Group:

Migriane

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

紧张型头痛组

样本量:

30

Group:

Tension-Type Headache

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

正常组

样本量:

30

Group:

Control

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei Province 

City:

 

单位(医院):

武汉大学人民院 

单位级别:

三级甲等医院 

Institution
hospital:

Renmin hospital of Wuhan university  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

认知功能

指标类型:

主要指标 

Outcome:

cognitive function

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:

血液

组织:

Sample Name:

blood

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 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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):

本课题组于本临床试验所获原始数据将于本试验结束后6个月在中国临床试验注册中心(http://www.chictr.org.cn/showproj.aspx?proj=9624)进行共享。

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

The original data obtained in this clinical trial will be shared at 6 months after the end of this trial at the China Clinical Trials Registry (http://www.chictr.org.cn/showproj.aspx?proj=9624).

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:

病例报告表由试验协调员与试验管理小组一起设计。所有电子患者身份信息将在一个安全的,受密码保护的数据库上进行,只能由基本人员访问。 具有患者识别信息的纸张形式将在安全锁定的文件柜中。直接访问源数据/文件将需要与试用有关的监控。所有纸张和电子数据将在试验完成后至少保留五年。

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

The case report form is designed by the test coordinator and the test management team. All electronic patient identity information will be conducted on a secure, password-protected database and can only be accessed by the basic person. Paper forms with patient identification information will be carried out in a securely locked cabinet. Direct access to source data / files will require trial-related monitoring. All paper and electronic data will remain for at least five years after the test is completed.

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:

 2019-07-05
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