Today is 2020-07-15

The cortical excitatory response by monophasic pulse waveform electroacupuncture predicts potential on the upper extremity recovery in patients with acute stroke
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注册号:

Registration number:

ChiCTR2000033321 

最近更新日期:

Date of Last Refreshed on:

2020-06-01 

注册时间:

Date of Registration:

2020-05-28 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

单相脉冲电针刺激皮质兴奋性反应预测急性脑卒中患者上肢恢复的潜能 

Public title:

The cortical excitatory response by monophasic pulse waveform electroacupuncture predicts potential on the upper extremity recovery in patients with acute stroke 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

电针结合重复经颅磁刺激个体化治疗脑梗死伴上肢运动功能障碍的疗效及机制研究 

Scientific title:

Effect and mechanism of electroacupuncture combined with repeated transcranial magnetic stimulation in the individualized treatment of cerebral infarction with upper extremity motor dysfunction  

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:

ChiMCTR2000003361 

申请注册联系人:

钟燕彪 

研究负责人:

单春雷 

Applicant:

Yanbiao Zhong 

Study leader:

Chunlei Shan 

申请注册联系人电话:

Applicant telephone:

+86 18201826956 

研究负责人电话:

Study leader's telephone:

+86 18201826956 

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:

zhongyb2010@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhongyb2010@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:

中国上海虹口区甘河路110号 

研究负责人通讯地址:

中国上海浦东新区张江蔡伦路1200号 

Applicant address:

110 Ganhe Road, Hongkou District, Shanghai, China 

Study leader's address:

1200 Cailun Road, Pudong New District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200003 

研究负责人邮政编码:

Study leader's postcode:

201203 

申请人所在单位:

上海中医药大学附属岳阳中西医结合医院 

Applicant's institution:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional 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:

2019-076 

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:

上海中医药大学附属岳阳中西医结合医院伦理委员会 

Name of the ethic committee:

Ethics Committee in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-09 

伦理委员会联系人:

殷从全 

Contact Name of the ethic committee:

CongQuan Yin 

伦理委员会联系地址:

中国上海浦东新区张江蔡伦路1200号 

Contact Address of the ethic committee:

1200 Cailun Road, Pudong New District, Shanghai, 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:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine  

研究实施负责(组长)单位地址:

中国上海浦东新区张江蔡伦路1200号 

Primary sponsor's address:

1200 Cailun Road, Pudong New District, Shanghai, 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):

上海

市(区县):

Shanghai

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

浦东新区张江蔡伦路1200号

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address:

1200 Cailun Road, Pudong New District

经费或物资来源:

上海市卫生和计划生育委员会 

Source(s) of funding:

Shanghai health and family planning commission 

研究疾病:

脑卒中 

Target disease:

stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

运用诊断性干预方法评估大脑皮质兴奋性反应,判断脑卒中功能障碍预后可能性,为有针对性的制定脑卒中的康复治疗策略提供依据。  

Objectives of Study:

To assess the cortical excitatory response for judge the prognosis of stroke dysfunction, and to provide evidence for the formulation of rehabilitation strategies.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

(1)符合脑梗死中西医结合诊断标准; (2)MRI或者CT确诊为脑梗死伴有上肢运动功能障碍患者; (3)患者年龄≥30周岁且≤80周岁,性别不限; (4)首次发病,病程发病1周内,肢体功能障碍程度不限; (5)意识清楚,无明显失语症,无明显认知功能障碍; (6)发病前无肢体残缺、无运动功能障碍,无感觉功能障碍; (7)颅骨无缺损,无其他躯体性疾病,可耐受1h的检测; (8)自愿参加本研究项目并签署知情同意书。  

Inclusion criteria

(1) Patients meet the diagnostic criteria of cerebral infarction with integrated Chinese and western medicine; (2) Patients diagnosed with cerebral infarction with upper limb movement dysfunction by MRI or CT; (3) Patients aged 30 to 80 years old male and female; (4) No limitation on the degree of limb dysfunction within 1 week after the first onset of disease course; (5) Clear consciousness without obvious aphasia or cognitive dysfunction; (6) No limb deformity, motor dysfunction or sensory dysfunction before onset; (7) Without skull defect or other physical diseases, and can withstand the detection for 1h; (8) Sign informed consent.  

排除标准:

(1)蛛网膜下腔出血、脑栓塞、腔隙性脑梗死、脑外伤患者,有心肺疾病等严重系统性疾病不能耐受康复治疗者; (2)两次以上或者多次脑梗死患者,或伴认知、言语、心理、精神、视力及听觉等障碍; (3)有经颅磁刺激和磁共振(MRI)检查的禁忌症如体内有起搏器、金属植入物等,妊娠期或哺乳期妇女患者; (4)发病前已有肢体运动功能障碍,应用改变大脑皮质兴奋性的药物(抗癫痫药、镇静催眠类药物等); (5)妊娠期或哺乳期妇女。 

Exclusion criteria:

(1) Patients with subarachnoid hemorrhage, cerebral embolism, lacunar cerebral infarction and cerebral trauma, who have serious systemic diseases such as cardiopulmonary diseases and cannot tolerate rehabilitation treatment; (2) Patients with more than two or more cerebral infarction, or with cognitive, verbal, psychological, mental, visual and auditory disorders; (3) Contraindication of transcranial magnetic stimulation (TMS) and magnetic resonance (MRI) examination, such as pacemaker, metal implant, etc., in pregnant or lactating women; (4) Patients with motor dysfunction before onset should apply drugs (antiepileptic drugs, sedative and hypnotic drugs, etc.) to change the excitability of cerebral cortex; (5) Pregnant or lactating women. 

研究实施时间:

Study execute time:

From2019-04-01To 2022-12-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

单相脉冲电针刺激皮质兴奋性反应

Index test:

The cortical excitatory response by monophasic pulse waveform electroacupuncture

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

脑卒中伴有上肢运动功能障碍的患者

例数:

Sample size:

20

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Stroke patients with upper extremity motor dysfunction

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

运动诱发电位

指标类型:

主要指标 

Outcome:

motor evoked potential (MEP)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

短间隔皮质内抑制

指标类型:

主要指标 

Outcome:

short-interval intracortical inhibition

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

长间隔皮质内抑制

指标类型:

主要指标 

Outcome:

short-interval intracortical inhibition

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

120%运动阈值MEP

指标类型:

主要指标 

Outcome:

120%resting motor threshold

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肩外展和手指伸展肌力评分

指标类型:

次要指标 

Outcome:

shoulder abduction and finger extension

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Fugl-Meyer上肢运动功能评分

指标类型:

主要指标 

Outcome:

Fugl-Meyer motor assessment of the upper extremity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

美国国立卫生研究院中风量表

指标类型:

次要指标 

Outcome:

The National Institutes of Health Stroke Scale

Type:

Secondary 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:

组织:

Sample Name:

N/A

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 30 years
最大 Max age 80 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:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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-based public database, please provide the url):

ResMan (www.medresman.org)

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-28
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