Exploring the inherent correlation and mechanisms between manifestation Qi arrival and therapeutic effect based on the "Tong Guan Li Qiao" acupuncture therapy

注册号:

Registration number:

ITMCTR2025000060

最近更新日期:

Date of Last Refreshed on:

2025-01-10

注册时间:

Date of Registration:

2025-01-10

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于“通关利窍”针刺法的“针刺外在表征-气至-有效”的内在关联性与机制研究

Public title:

Exploring the inherent correlation and mechanisms between manifestation Qi arrival and therapeutic effect based on the "Tong Guan Li Qiao" acupuncture therapy

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于“通关利窍”针刺法的“针刺外在表征-气至-有效”的内在关联性与机制研究

Scientific title:

Exploring the inherent correlation and mechanisms between manifestation Qi arrival and therapeutic effect based on the "Tong Guan Li Qiao" acupuncture therapy

研究课题的正式科学名称简写:

Scientific title acronym:

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:

张梦龙

研究负责人:

樊小农

Applicant:

Menglong Zhang

Study leader:

Xiaonong Fan

申请注册联系人电话:

Applicant telephone:

+86 156 2191 2395

研究负责人电话:

Study leader's telephone:

+86 139 0208 0823

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:

zzzml971020@163.com

研究负责人电子邮件:

Study leader's E-mail:

fanxiaonong@163.com

申请单位网址(自愿提供):

Study leader's 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:

天津市西青区昌凌路88号

研究负责人通讯地址:

天津市西青区昌凌路88号

Applicant address:

88 Changling Road Xiqing District Tianjin

Study leader's address:

88 Changling Road Xiqing District Tianjin

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:

天津中医药大学第一附属医院

Applicant's institution:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

TYLL2024[K]字066

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

天津中医药大学第一附属医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/10/30 0:00:00

伦理委员会联系人:

郑子琦

Contact Name of the ethic committee:

Ziqi Zheng

伦理委员会联系地址:

中国天津市西青区昌凌路88号

Contact Address of the ethic committee:

88 Changling Road Xiqing District Tianjin

伦理委员会联系人电话:

Contact phone of the ethic committee:

022-27986258

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yfyiec@163.com

研究实施负责(组长)单位:

天津中医药大学第一附属医院

Primary sponsor:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

中国天津市西青区昌凌路88号

Primary sponsor's address:

88 Changling Road Xiqing District Tianjin

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

天津市西青区昌凌路88号

Institution
hospital:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Address:

88 Changling Road Xiqing District Tianjin

经费或物资来源:

国家自然科学基金

Source(s) of funding:

National Natural Science Foundation of China

研究疾病:

脑卒中后吞咽障碍

研究疾病代码:

Target disease:

Post-stroke dysphagia

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

1.明确针刺外在表征、气至程度与远期疗效的内在关联,并提供多维度、多层次评价“气至而有效”的试验验证; 2.明确“气至而有效”的即刻及累积中枢机制。

Objectives of Study:

1. To clarify the inherent correlation between manifestation the degree of Qi arrival and long-term therapeutic effects and to provide a multi-dimensional and multi-level evaluation for test verification of "Qi Arrival and then Effect Appear." 2. To clarify the immediate and cumulative central mechanisms underlying "Qi Arrival and then Effect Appear."

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

PSD患者:1.符合缺血性脑卒中及吞咽障碍的诊断标准;2.卒中病程6个月内;3.吞咽障碍严重程度洼田饮水试验(WST) 3-5级;4.年龄40-80岁;5.母语为汉语;6.经爱丁堡利手量表(EHI)判断为右利手;7.生命体征平稳,能够理解并配合完成研究;8.病人或法定代理人同意签署知情同意书。 健康受试者:1.年龄40-80岁;2.经爱丁堡利手量表(EHI)判断为右利手;3.母语为汉语;4.无吞咽障碍;5.影响健康的危险因素控制在与其年龄相适应的范围内;6.不以治疗获益为目的参加临床实验;7.身体处于健康状态,能够配合完成功能磁共振扫描;8.本人或法定代理人同意签署知情同意书。

Inclusion criteria

PSD patients: 1. Meet the diagnostic criteria of ischemic stroke and dysphagia; 2. The duration of stroke lasts within 6 months; 3. Severity of Dysphagia WST 3-5; 4. Age range from 40 to 80 years old; 5. Native language is Chinese; 6. Determined as right-handed by the Edinburgh Handedness Inventory (EHI); 7. Stable vital signs able to understand and cooperate in completing research; 8. The patient or legal representative agrees to sign the informed consent form. Healthy participants: 1. Age range from 40 to 80 years old; 2. Determined as right-handed by the Edinburgh Handedness Inventory (EHI); 3. Native language is Chinese; 4. Without swallowing disorders; 5. Health risk factors are controlled appropriately for one's age; 6. Participating in clinical trials without seeking therapeutic benefit; 7. In good health and able to cooperate for fMRI scans; 8. The participant or legal representative agrees to sign the informed consent form.

排除标准:

PSD患者:1.由于其他疾病(如头颈癌、口咽喉疾病等)引起的吞咽障碍者;2.本次卒中发病前即存在吞咽障碍;3.预期生存时间小于3个月者;4.存在延髓损伤的患者;5.既往患有脑出血、脑肿瘤导致脑部MRI结构异常的疾病;6.存在磁共振扫描禁忌症,如体内植入金属、人工耳蜗或幽闭恐惧症等;7.焦虑自评量表(SAS)≥50分和抑郁自评量表(SDS)≥50分;8.存在严重烟酒、药物依赖;9.近1周参与其他临床试验或接受针刺治疗者。 健康受试者:1.存在磁共振扫描禁忌症,如体内植入金属、人工耳蜗或幽闭恐惧症等;2.SAS≥50分和SDS≥50分;3.存在脑梗死、脑出血、脑外伤等颅脑部器质性病变,癫痫、认知障碍、抑郁症等神经精神病史,心、肺、肝、肾等重要脏器的严重功能损害、运动功能严重损害以及恶性肿瘤;4.存在严重烟酒、药物依赖;5.近1周参与其他临床试验或接受针刺治疗者。

Exclusion criteria:

PSD patients: 1. Dysphagia caused by other diseases (such as Head and neck cancer oropharyngeal diseases etc.); 2. Dysphagia existed before the onset of this stroke; 3. Those with an expected survival time of less than 3 months; 4. Patients with medullary injury; 5. Previously suffering from diseases such as cerebral hemorrhage or brain tumors leading to abnormal brain MRI structure; 6. There are contraindications to MRI scanning such as metal implantation cochlear implants or Claustrophobia; 7. Self Rating Anxiety Scale (SAS)>=50 points and Self Rating Depression Scale (SDS)>=50 points; 8. Have severe addictions to tobacco alcohol or drugs; 9. Participated in other clinical trials or received acupuncture in the past week. Healthy participants: 1. There are contraindications of MRI scanning such as metal implantation a cochlear implant or claustrophobia; 2. Self Rating Anxiety Scale (SAS)>=50 points and Self Rating Depression Scale (SDS)>=50 points; 3. Have organic brain lesions like cerebral infarction hemorrhage or injury history. 4.Have severe addictions to tobacco alcohol or drugs; 5. Participated in other clinical trials or received acupuncture in the past week.

研究实施时间:

Study execute time:

From 2024-11-01

To      2027-12-31

征募观察对象时间:

Recruiting time:

From 2025-01-20

To      2027-11-30

干预措施:

Interventions:

组别:

常规表征组

样本量:

20

Group:

control group

Sample size:

干预措施:

常规针刺法

干预措施代码:

Intervention:

conventional acupuncture

Intervention code:

组别:

健康人组

样本量:

20

Group:

health control

Sample size:

干预措施:

无(招募健康受试者20名,按照年龄、性别、受教育程度与纳入的PSD患者进行匹配)

干预措施代码:

Intervention:

NONE(Recruit 20 healthy subjects matched with the enrolled PSD patients regarding age, gender, and education level)

Intervention code:

组别:

特异性表征组

样本量:

20

Group:

experimental group

Sample size:

干预措施:

“通关利窍”针刺法

干预措施代码:

Intervention:

"Tong Guan Li Qiao" acupuncture therapy

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

单位级别:

三甲

Institution/hospital:

The First Teaching Hospital of Tianjin University of Tradition al Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

针刺盲法评价

指标类型:

附加指标

Outcome:

Blindacupuncture evaluation

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

均方根振幅

指标类型:

主要指标

Outcome:

root mean square,RMS

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

吞咽障碍特异性生活质量量表

指标类型:

次要指标

Outcome:

Swallowing Quality of Life Questionnaire,SWAL-QoL

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

比率低频振幅

指标类型:

主要指标

Outcome:

Fractional Amplitude oLow Frequency Fluctuation,fALFF

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能连接分析

指标类型:

主要指标

Outcome:

Functional connectivity,FC

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

波动百分率振幅

指标类型:

主要指标

Outcome:

Percent Amplitude of Fluctuation,PerAF

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平均扩散率

指标类型:

主要指标

Outcome:

mean diffusivity,MD

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卒中量表

指标类型:

次要指标

Outcome:

National Institute of Health stroke scale,NIHSS

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低频振幅

指标类型:

主要指标

Outcome:

Amplitude of Low Frequency Fluctuation,ALFF

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

洼田饮水试验

指标类型:

次要指标

Outcome:

Water Swallowing Test,WST

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者依从性及安全性评价量表

指标类型:

次要指标

Outcome:

Patient Adherence and Safety Assessment Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

标准吞咽功能评价量表

指标类型:

次要指标

Outcome:

Standardized Swallowing Assessment,SSA

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中值频率

指标类型:

主要指标

Outcome:

nedian frequency,MF

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

电视透视吞咽功能检查

指标类型:

次要指标

Outcome:

Video Fluoroscopic Swallowing Study,VFSS

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核磁共振检查过程感觉评估表

指标类型:

附加指标

Outcome:

MRI Process Sensory Record

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

针刺得气感评价量表

指标类型:

附加指标

Outcome:

modified Massachusetts General Hospital Acupuncture Sensation Scale,M-MASS

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

微循环血流灌注量

指标类型:

主要指标

Outcome:

microcirculation blood perfusionvolume,MBPU

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

针刺可信度评价

指标类型:

附加指标

Outcome:

Acupuncture reliability evaluation

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应/不良事件报告表

指标类型:

次要指标

Outcome:

Record adverse events (AE)and serious adverse events (SAE)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能性经口摄食分级

指标类型:

次要指标

Outcome:

Functional Oral Intake Scale,FOIS

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一般临床资料异常情况记录

指标类型:

次要指标

Outcome:

Recording of Abnommal Clinical Data

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

各向异性分数

指标类型:

主要指标

Outcome:

fraction anisotropy,FA

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

局部一致性

指标类型:

主要指标

Outcome:

Regional homogeneity,ReHo

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:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 40
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

为平衡性别、年龄等预后及fMRI相关因素,按最小不平衡指数法随机分为:特异性表征组(“通关利窍”针刺法),常规表征组(常规针刺法)。

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

To balance factors like gender age and fMRI participants were randomly divided into two groups using the minimum imbalance index: the specific manifestation group ("Tong Guan Li Qiao" acupuncture) and the routine group (conventional acupuncture).

盲法:

研究采用单盲的试验设计,即受试者在试验结束前不知道自己的分组,但由于针刺操作的特殊性,无法对针灸师实施盲法。此外,数据收集者、统计分析者对试验分组不知情。

Blinding:

This study used a single-blind trial design i.e. participants did not know their grouping until the end of the trial. Due to the peculiarities of acupuncture procedures acupuncturists could not be blinded. In addition the data collectors and statistical analysts were unaware of the trial grouping.

是否共享原始数据:

IPD sharing:

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):

联系研究者获取

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

Contact the investigator for access

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:

电子采集和管理系统

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

Electronic Data Capture EDC

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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