面神经功能评估及康复训练机制

注册号:

Registration number:

AMCTR-OOC-18000224 

注册号获得时间:

Date of releasing the registration number:

2018/11/12 22:09:17 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

面神经功能评估及康复训练机制 

Public title:

The Research of the fuction evaluation of facial nerve and the mechanisms of rehabilitation training 

研究课题的正式科学名称:

面神经功能评估及康复训练机制 

Scientific title:

The Research of the fuction evaluation of facial nerve and the mechanisms of rehabilitation training 

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:

黄杏贤 

研究负责人:

王玲 

Applicant:

Huang Xingxian 

Study leader:

Wang Ling 

申请注册联系人电话:

Applicant telephone:

13632822278 

研究负责人电话:

Study leader's telephone:

13823357062 

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:

732545909@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wanglinga816@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:

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:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong 

Study leader's address:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong 

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:

Shenzhen Traditional Chinese Medicine Hospital 

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:

深中医伦审(研)(2017)5 

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:

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:

2017-09-20 

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:

广东省深圳市福田区福华路1号 

Primary sponsor's address:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong 

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:

No.1 Fuhua Rd, Futian District, Shenzhen,Guangdong

经费或物资来源:

深圳市科技计划项目资金 

Source(s) of funding:

Technology plan in Shenzhen 

研究疾病:

周围性面瘫 

Target disease:

peripheral facial paralysis 

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:

其它 

Study phase:

Other 

研究目的:

本项目拟以面瘫疾病作为临床切入点,利用激光散斑成像技术对针灸过程中面部血流微循环进行监测,并通过机器学习、图像分割等高科技技术对实时监测算法、数据采样及数码成像方法进行研究。并搭建患者面部表情数据库,结合量表评估及电生理检测,研究表面血流灌注量、面部结构对称性与其间的相关性,探索激光散斑血流成像技术在面瘫病情评估的客观性与有效性。分析针灸治疗前后及治疗过程中的血流微循环变化,为研究针灸治疗面瘫的机理机制及疗效评价提供一种新可视化客观的评价方法。并开发一套具有多种训练模式的可交互增强现实面神经功能康复训练系统,可大大提高患者的康复训练效果。 

Objectives of Study:

This study intends to monitor the facial blood perfusion with LASCA technology and establish the real-time monitoring algorithm, digital imagery and digital imaging method with machine learning and image segmentation technology. Establish the facial expression databases and explore the effectiveness and objectivity of the evaluation of facial palsy with the correlation between the facial blood perfusion and facial symmetry with the assessment of EMG and scale. We would provide a new visual method to assess the efficacy evaluation and mechanism of acupuncture on the analysis of the change of facial blood perfusion during acupuncture. And develop a rehabilitation training system of facial nerve based on interactive augmented reality which have multiple training modes to improve the rehabilitation training effectiveness. 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.符合面瘫(TCD 编码:BNV120)和面神经麻痹(ICD-10编码G51.001)诊断的患者; 2.病程为面瘫急性期、恢复期、后遗症期,即发病15天、15天至 3 个月、3个月以上 3.患者意识清醒,适合并能配合治疗、检查; 4.12 岁≤年龄≤70 岁; 5.自愿参加本研究并签署知情同意; 

Inclusion criteria

1.Meet the peripheral facial palsy(BNV120 of TCD Code in Chinese medicine and G51.001 of ICD-10 Code) diagnostic standard. 2.Acute, recovering and sequela stage (i.e. within 15 days, 15 days to 3 months and more than three months) after the onset of peripheral facial palsy. 3.Conscious and good treatment and test compliance 4.The age from 12-70 years old. 5.Voluntary participation and signing of informed consent. 

排除标准:

1.脑血管病、桥小脑角、颞骨、侧颅底、腮腺良恶性肿瘤等造成的面神经麻痹者; 2.梅尔克松-罗森塔尔综合征、格林巴利综合征等继发的面神经麻痹者; 3.因外伤、手术等引起的面神经损伤者; 4.伴随颜面部肌肉痉挛者; 5.合并心衰或严重肝、肾功能异常者; 6.神志不清者或者语言理解表达障碍,不能正确表述自己的意见者; 7.妊娠期或哺乳期妇女; 8.目前正参加或三个月内参加过其他临床研究者; 9.不能完成基本疗程,依从性可能不好者(即不能坚持治疗); 10.针刺穴位或穴位附近皮肤有感染者。 

Exclusion criteria:

1.Peripheral Facial Palsy caused by cerebrovascular disease, benign and malignant tumor of cerebellopontine Angle, temporal bone, Lateral Skull parotid,parotid gland etc. 2.Peripheral Facial Palsy caused by Melkersson-Rosenthal Syndrome ,Guillain-Barre syndrome; 3.Facial nerve injury after trauma and surgery; 4.Facial Spasm; 5.Heart failure or serious liver and kidney dysfunction; 6.Unconscious or Language and Comprehension Barriers; 7.During pregnancy or lactation; 8.Participate other clinical research within 3 months; 9.Poor compliance and cannot complete the course of research; 10.Skin infection around the points area. 

研究实施时间:

Study execute time:

From2017-07-01To 2020-06-30 

干预措施:

Interventions:

组别:

不分组

样本量:

200

Group:

no grouping

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

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:

三级甲等医院 

Institution
hospital:

Shenzhen Traditional Chinese Medicine Hospital  

Level of the institution:

3A Class Hospital 

测量指标:

Outcomes:

指标中文名:

表面血流灌注量

指标类型:

主要指标 

Outcome:

facial blood perfusion

Type:

Primary indicator 

指标中文名:

House-Brackmann面神经功能分级

指标类型:

次要指标 

Outcome:

House Brackmann Scale

Type:

Secondary indicator 

指标中文名:

瞬目反射

指标类型:

次要指标 

Outcome:

Blink Reflex

Type:

Secondary indicator 

指标中文名:

神经传导速度

指标类型:

次要指标 

Outcome:

nerve conduction velocity

Type:

Secondary 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 12 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):

无随机方法

性别:

男女均可

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

No Randomization Procedure

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(http://www.medresman.org)

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:病例报告表,血流检测数据,肌电检测数据 2. 数据库:Excel,激光散斑检测、肌电检测设备

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

1.Research Data: Case Report Form,the data of blood perfusion and EMG signals. 2.Databsse: Excel, private database of LASCA and EMG equipment。

创建人:

Creater Name:

 2018-10-31
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