电针治疗周围性面瘫后遗症患者大脑运动皮层功能重组的作用研究

注册号:

Registration number:

AMCTR-IOR-18000234 

注册号获得时间:

Date of releasing the registration number:

2018/12/20 9:52:39 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

电针治疗周围性面瘫后遗症患者大脑运动皮层功能重组的作用研究 

Public title:

Effects of electroacupuncture for functional reorganization of cerebral motor cortex in patients with peripheral facial paralysis. 

研究课题的正式科学名称:

电针治疗周围性面瘫后遗症患者大脑运动皮层功能重组的作用研究 

Scientific title:

Effects of electroacupuncture for functional reorganization of cerebral motor cortex in patients with peripheral facial paralysis. 

研究课题代号(代码):

Study subject ID:

国家自然科学基金面上项目81273675 

在其它机构的注册号:

Secondary ID:

ChiCTR1800019809 

申请注册联系人:

李文婷 

研究负责人:

刘健华 

Applicant:

WenTing Li 

Study leader:

Jian Hua Liu 

申请注册联系人电话:

Applicant telephone:

+86 13760722655 

研究负责人电话:

Study leader's telephone:

+86 13729889452 

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:

13760722655@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jianhualiu@gzucm.edu.cn 

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:

广州市大德路111号广东省中医院针灸科 

研究负责人通讯地址:

广州市大德路111号广东省中医院针灸科 

Applicant address:

111 Dade Road, Guangzhou, Guangdong, China 

Study leader's address:

111 Dade Road, Guangzhou, 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:

广东省中医院 

Applicant's institution:

Guangdong Provincail Hospital 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:

Y2017-171-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-27 

研究实施负责(组长)单位:

广东省中医院 

Primary sponsor:

Guangdong Provincail Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

广州市大德路111号广东省中医院针灸科 

Primary sponsor's address:

111 Dade Road, Guangzhou, Guangdong, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省中医院

具体地址:

广州市大德路111号广东省中医院针灸科

Institution
hospital:

Guangdong Provincail Hospital of Traditional Chinese Medicine

Address:

111 Dade Road, Guangzhou, Guangdong, China

经费或物资来源:

国家自然科学基金面上项目81273675 

Source(s) of funding:

NSFC (81673888,81273675) 

研究疾病:

周围性面瘫后遗症期 

Target disease:

The sequela of peripheral facial paralysis 

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:

探讨电针刺激面口部穴位对患者大脑运动皮层的手面区功能重组的可塑性作用。 

Objectives of Study:

To investigate the plasticity of the acupoint of the electric needle stimulation surface to the functional recombination of the cerebral motor cortex. 

研究设计:

随机交叉对照 

Study design:

Randomized cross-over control 

纳入标准:

(1)符合周围性面瘫的中西医诊断标准、分期标准和定位标准者 (2)至少六个月诊断为周围性面瘫(3)面瘫表现为单侧(4)年龄在 18 ~ 65 岁者(5)签署知情同意书, 自愿参加本项研究者 。 

Inclusion criteria

(1) comply with the surrounding facial paralysis of the western and Chinese medicine diagnosis standard, the installment and positioning standards; (2) diagnosed with at least six months around sexual facial paralysis (3) facial paralysis of unilateral; (4) Aged from 18 to 65 years; (5) signed informed consent, volunteered for the researchers of this item. 

排除标准:

(1)中枢性面瘫;(2)双侧面瘫;(3)糖尿病周围神经病变等继发及原发性神经系统病变(4)白血病、血小板减少等有出血倾向者;(5)久病体弱、严重神经官能症、癫痫、痴呆、妊娠或哺乳妇女;(6)合并严重心、肝、肾、脑血管、肿瘤疾病、感染疾病、自身免疫性疾病等,重度高热患者;(7)安装有支架、心脏起搏器及人工耳蜗等金属置入物等;(8)针刺穴位或穴位附近皮肤有感染者; 或有凝血功能障碍的患者 

Exclusion criteria:

(1) central facial paralysis; (2) bilateral palsy; (3) secondary and primary neuropathy; (4) leukemia, thrombocytopenia, etc.; (5) chronic disease, severe neurosis, epilepsy, dementia, pregnancy or lactation; (6) severe hyperthermia patients with serious heart, liver, kidney, cerebral vessels, tumor diseases, infectious diseases, autoimmune diseases, etc.; (7) installation of metal implants such as stents, pacemakers and cochlear implants; (8) infection of the skin near acupoint or acupoint;Or patients with coagulopathy. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-06-01 

干预措施:

Interventions:

组别:

口面部电针组

样本量:

20

Group:

Group 1

Sample size:

干预措施:

电针刺激口面部穴位

干预措施代码:

Intervention:

electroacupuncture on orofacial acupoints

Intervention code:

组别:

口面部+合谷穴假针刺组

样本量:

20

Group:

Group 2

Sample size:

干预措施:

口面部+合谷穴假针刺

干预措施代码:

Intervention:

sham electroacupuncture on orofacial acupoints

Intervention code:

组别:

合谷穴电针组

样本量:

20

Group:

Group 3

Sample size:

干预措施:

电针刺激合谷穴

干预措施代码:

Intervention:

electroacupuncture on Hegu

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

China 

City:

 

单位(医院):

广东省中医院 

单位级别:

三甲 

Institution
hospital:

Guangdong Provincail Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

House-Brackmann面神经分级量表

指标类型:

主要指标 

Outcome:

House-Brackmann scale

Type:

Primary indicator 

指标中文名:

面部残疾指数量表

指标类型:

主要指标 

Outcome:

Facial Disability Index scale

Type:

Primary indicator 

指标中文名:

大脑运动皮层手面区分布规律

指标类型:

主要指标 

Outcome:

Distribution of the area of the hand and face of the brain motor cortex.

Type:

Primary indicator 

指标中文名:

肌电图

指标类型:

主要指标 

Outcome:

EMG

Type:

Primary indicator 

指标中文名:

功能性MRI

指标类型:

次要指标 

Outcome:

functional MRI

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

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 70 years

随机方法(请说明由何人用什么方法产生随机序列):

电脑区组随机(随机区组4、8、12)

性别:

男女均可

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

computer block randomization with the randomized blocks in 4, 8 and 12

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:

 2018-12-02
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