今天是:2022-08-12 星期五

基于fNIRS探究rTMS联合运动训练对脑卒中脑功能网络可塑性重组的影响
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注册号:

Registration number:

ChiCTR2200061885 

最近更新日期:

Date of Last Refreshed on:

2022-07-06 

注册时间:

Date of Registration:

2022-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于fNIRS探究rTMS联合运动训练对脑卒中脑功能网络可塑性重组的影响 

Public title:

Effect of High-frequency rTMS Combined with Motor Training on Plastic Reorganization of Brain Functional Networks in Stroke based on fNIRS 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肢体运动功能障碍动态量化评估与智能康复训 练系统研发 

Scientific title:

Research and development of dynamic quantitative evaluation and intelligent rehabilitation training system for limb movement 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:

 

申请注册联系人:

霍聪聪 

研究负责人:

李增勇 

Applicant:

Huo Congcong 

Study leader:

Li Zengyong 

申请注册联系人电话:

Applicant telephone:

18518500301 

研究负责人电话:

Study leader's telephone:

010-58122886 

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:

843533774@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

lizengyong@nrcrta.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

国家康复辅具研究中心 

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:

北京市经济技术开发区荣华中路1号 

研究负责人通讯地址:

北京市经济技术开发区荣华中路1号 

Applicant address:

No.1 Ronghuazhong Road, Beijing BDA 

Study leader's address:

No.1 Ronghuazhong Road, Beijing BDA 

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:

北京航空航天大学 

Applicant's institution:

Beihang 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:

20200519 

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:

国家康复辅具研究中心附属康复医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of rehabilitation Hospital affiliated to National Research Center for Rehabilitation Technical Aids 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-19 

伦理委员会联系人:

张静莎 

Contact Name of the ethic committee:

Jingsha Zhang 

伦理委员会联系地址:

北京市大兴区荣华中路1号国家康复辅具研究中心 

Contact Address of the ethic committee:

No.1 Ronghuazhong Road, Beijing BDA 

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:

lizengyong@nrcrta.cn 

研究实施负责(组长)单位:

国家康复辅具研究中心 

Primary sponsor:

National Research Center for Rehabilitation Technical Aids 

研究实施负责(组长)单位地址:

北京市大兴区荣华中路1号国家康复辅具研究中心 

Primary sponsor's address:

No.1 Ronghuazhong Road, Beijing BDA 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家康复辅具研究中心附属康复医院

具体地址:

北京市大兴区荣华中路1号国家康复辅具研究中心

Institution
hospital:

Rehabilitation Hospital affiliated to National Research Center for Rehabilitation Technical Aids

Address:

No.1 Ronghuazhong Road, Beijing BDA

经费或物资来源:

国家重点研发专项(2020YFC2004200) 

Source(s) of funding:

National Key Research and Development Project (2020YFC2004200) 

研究疾病:

脑卒中 

Target disease:

Stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1)本研究旨在结合近红外脑功能及临床功能量表等信息,研究上肢运动训练联合经颅磁刺激康复范式对脑卒中患者进行脑功能评估,研究不同康复干预范式对脑功能重塑的影响。 2)通过近红外脑功能参数与临床运动功能的协同分析,帅选灵敏性、特异性的近红外脑功能指标,建立近红外参数与运动功能之间的定量关系。 3)对研究结果个性化分析,确定神经调控与上肢运动协同训练的临床康复路径,为临床干预策略的制定和优化提供依据。 

Objectives of Study:

1. This study is aimed to investigate the cortical plastic changes induced by rTMS combined with bilateral arm training (BAT) based on functional near-infrared spectroscopy (fNIRS) and clinical assessment in patients with stroke. 2. Analyze the relationship between fNIRS brain function parameters and clinical motor function and select the sensitive and specific NIR brain function indexes. 3. Conduct the personalized analysis of the research results to determine the clinical rehabilitation path of nerve regulation and upper limb movement coordination training, providing a basis for the formulation and optimization of clinical intervention 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:

横断面 

Study design:

Cross-sectional 

纳入标准:

脑卒中患者: 1)首次脑卒中,经头颅CT或MRI确诊; 2)存在轻度、中度或重度运动功能障碍; 3)患者无明显认知和言语功能障碍; 健康对照: 1) 无高血压或血压控制良好; 2) 无心传导系疾病; 3) 无癫痫史及家族癫痫史。 

Inclusion criteria

For stroke: 1.First stroke, confirmed by head CT or MRI; 2.Mild, moderate or severe motor dysfunction; 3.No obvious cognitive and speech dysfunction and ability to understand and follow instruction. For healthy controls: Healthy control: 1) No hypertension or good blood pressure control; 2) No cardiac conduction system diseases; 3) No history of epilepsy or family history of epilepsy. 

排除标准:

脑卒中患者: 1)既往有脑卒中病史,脑外伤史,脑肿瘤史; 2)并发严重心、肺、肝、肾功能障碍或其他严重躯体疾病; 3)既往癫痫及癫痫家族史; 4)人体中植入的金属如心脏起搏器,头颅部的金属等; 5)出现新的梗死灶或继发性出血,病情恶化者; 6)有严重颈椎病变包括严重颈锥管狭窄、颈椎不稳定者。 健康对照: 1)头颈部有金属植入物。 

Exclusion criteria:

Stroke patients: 1) Previous history of stroke, traumatic brain injury, or brain tumor; 2) complicated with serious heart, lung, liver, kidney dysfunction or other serious physical diseases; 3) Previous epilepsy and family history of epilepsy; 4) Metal implanted in the human body, such as cardiac pacemaker, skull metal, etc.; 5) New infarction foci or secondary bleeding and deterioration of the condition; 6) Patients with severe cervical spondylosis, including severe cervical conical stenosis and cervical instability. Healthy control: 1) Metal implants in the head and neck. 

研究实施时间:

Study execute time:

From2022-07-05To 2022-08-31 

征募观察对象时间:

Recruiting time:

From2022-07-05To 2022-07-30 

干预措施:

Interventions:

组别:

脑卒中组

样本量:

18

Group:

stroke group

Sample size:

干预措施:

双侧上肢运动训练

干预措施代码:

Intervention:

Bilateral upper limb motor training

Intervention code:

组别:

脑卒中组

样本量:

18

Group:

stroke group

Sample size:

干预措施:

高频rTMS联合双侧上肢运动训练

干预措施代码:

Intervention:

High frequency rTMS combined with bilateral upper limb motor training

Intervention code:

组别:

健康对照组

样本量:

18

Group:

control group

Sample size:

干预措施:

双侧上肢运动训练

干预措施代码:

Intervention:

Bilateral upper limb motor training

Intervention code:

组别:

健康对照组

样本量:

18

Group:

control group

Sample size:

干预措施:

高频rTMS联合双侧上肢运动训练

干预措施代码:

Intervention:

High frequency rTMS combined with bilateral upper limb motor training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

国家康复辅具研究中心附属康复医院 

单位级别:

二级医院 

Institution
hospital:

Rehabilitation Hospital affiliated to National Research Center for Rehabilitation Technical Aids  

Level of the institution:

secondary comprehensive 

测量指标:

Outcomes:

指标中文名:

脑血氧

指标类型:

主要指标 

Outcome:

cerebral oxygenation

Type:

Primary indicator 

测量时间点:

静息态和上肢康复训练任务过程中

测量方法:

功能性近红外光谱检测技术

Measure time point of outcome:

During resting state and upper limb rehabilitation training tasks

Measure method:

Functional near infrared spectroscopy detection technology

指标中文名:

临床功能表现

指标类型:

主要指标 

Outcome:

Clinical function preformance

Type:

Primary indicator 

测量时间点:

实验当天

测量方法:

临床量表

Measure time point of outcome:

The experiment on the same day

Measure method:

Clinical scales

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

N/A

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:

尚未开始

Not yet 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):

Not Applicable

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

Not Applicable

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否No

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):

N/A

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

N/A

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:

本研究数据管理由本课题组分别安排专人负责,以确保临床试验数据的真实性、完整性、私密性和可溯源性。

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

In order to ensure the authenticity, integrity, privacy and traceability of clinical trial data, the research group assigned special personnel to manage the data.

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:

 2022-07-06
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