ChiCTR2400090952 版本V1.0 版本创建时间2024/10/16 16:11:19 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400090952 

最近更新日期：

Date of Last Refreshed on：

2024-10-16 16:11:00 

注册时间：

Date of Registration：

2024-10-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于fNIRS的脑卒中后吞咽障碍患者脑功能特征及与临床吞咽量表相关性的研究

Public title：

The characteristics of brain function in patients with post-stroke dysphagia based on fNIRS and its correlation with clinical swallowing scales

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于fNIRS的脑卒中后吞咽障碍患者脑功能特征及与临床吞咽量表相关性的研究

Scientific title：

The characteristics of brain function in patients with post-stroke dysphagia based on fNIRS and its correlation with clinical swallowing scales

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：

张璐 

研究负责人：

张璐 

Applicant：

zhang lu 

Study leader：

zhang lu 

申请注册联系人电话：

Applicant telephone：

+86 136 7583 6899

研究负责人电话：

Study leader's telephone：

+86 136 7583 6899

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：

anxiaokui733@163.com

研究负责人电子邮件：

Study leader's E-mail：

anxiaokui733@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：

浙江省杭州市上城区庆春东路3号

研究负责人通讯地址：

浙江省杭州市上城区庆春东路3号

Applicant address：

3 Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province, China Department of Rehabilitation Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province, China

Study leader's address：

3 Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province, China Department of Rehabilitation Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province, 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：

浙江大学医学院附属邵逸夫医院

Applicant's institution：

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

研究负责人所在单位：

浙江大学医学院附属邵逸夫医院

Affiliation of the Leader：

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

邵逸夫医院伦审2024研第0486号

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：

浙江大学医学院附属邵逸夫医院伦理委员会

Name of the ethic committee：

Ethics Committee of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024-08-29 00:00:00

伦理委员会联系人：

金烨成

Contact Name of the ethic committee：

yecheng jin

伦理委员会联系地址：

浙江省杭州市上城区庆春东路3号

Contact Address of the ethic committee：

3 Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 571886643

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：

浙江大学医学院附属邵逸夫医院

Primary sponsor：

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

研究实施负责（组长）单位地址：

浙江省杭州市上城区庆春东路3号浙江大学医学院附属邵逸夫医院

Primary sponsor's address：

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province, 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)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江大学医学院附属邵逸夫医院

具体地址：

浙江省杭州市上城区庆春东路3号浙江大学医学院附属邵逸夫医院

Institution
hospital：

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Address：

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province, China

经费或物资来源：

浙江大学医学院附属邵逸夫医院

Source(s) of funding：

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Target disease：

stroke

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

本研究利用fNIRS技术评估并比较卒中后吞咽障碍患者、卒中后无吞咽障碍患者和健康对照组在静息状态及吞咽任务时脑区激活及功能连接的变化，并分析存在显著性差异的脑功能特征指标与临床吞咽评估量表间的相关性，以期为脑卒中吞咽障碍患者提供客观全面的评估，并为制定个体化康复策略提供理论依据。  

Objectives of Study：

In this study, fNIRS technology was used to evaluate and compare the changes of brain activation and functional connectivity in patients with dysphagia after stroke, patients without dysphagia after stroke, and healthy controls during resting state and swallowing tasks, and to analyze the correlation between the brain functional characteristics with significant differences and clinical swallowing assessment scales. In order to provide an objective and comprehensive assessment for stroke patients with dysphagia, and provide theoretical basis for formulating individualized rehabilitation strategies.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.脑卒中患者 ①年龄在30-85周岁之间。 ②于浙江大学医学院附属邵逸夫医院住院期间进行CT或MRI 扫描以确诊脑卒中。 ③首次发生的单侧脑卒中，病程≤6个月。 ④存在不同程度的吞咽障碍，洼田饮水试验2-5级。 ⑤生命体征平稳，听理解无明显异常，认知能力可，MMSE 评分≥21分。 ⑥自愿参加本研究，并签署知情同意书。若受试者因无行为能力等原因不能阅读和签署知情同意书的，则需由其监护人代理知情过程并签署知情同意书。若受试者因无阅读知情同意书能力（如：文盲受试者），则需由见证人见证知情过程并签署知情同意书。 2.健康受试者 ①年龄在30-85周岁之间。 ②既往无脑卒中、脑肿瘤、脑外伤及精神疾病史。 ③不存在吞咽功能障碍，进食评估问卷调查工具-10（EAT-10）＜3分。 ④自愿参加本研究，并签署知情同意书。若受试者因无行为能力等原因不能阅读和签署知情同意书的，则需由其监护人代理知情过程并签署知情同意书。若受试者因无阅读知情同意书能力（如：文盲受试者），则需由见证人见证知情过程并签署知情同意书。

Inclusion criteria

1.patient with a stroke ① Age between 30 and 85 years old. ② Stroke was confirmed by CT or MRI scan during hospitalization in Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. ③ first onset of unilateral stroke, the course of disease ≤6 months; ④ There were different degrees of dysphagia, and the Kubota drinking test was 2-5. ⑤ The vital signs were stable, there was no obvious abnormality in listening and comprehension, the cognitive ability was good, and the MMSE score was ≥21. ⑥ voluntarily participate in this study and sign the informed consent. If the subjects were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them during the informed consent process and sign the informed consent form. If the subjects were unable to read the informed consent form (e.g., illiterate subjects), witnesses were required to witness the informed consent process and sign the informed consent. 2.Healthy subjects ① Age between 30 and 85 years old. ② no previous history of stroke, brain tumor, brain trauma or mental illness. ③ No swallowing dysfunction, Eating assessment questionnaire-10 (EAT-10) score < 3. ④ voluntarily participated in this study and signed the informed consent. If the subjects were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them during the informed consent process and sign the informed consent form. If the subjects were unable to read the informed consent form (e.g., illiterate subjects), witnesses were required to witness the informed consent process and sign the informed consent.

排除标准：

①非脑血管意外所致的吞咽障碍，如运动神经元病、头颈肿瘤术后、肌肉疾病等。 ②重要脏器功能衰竭，或病情危重需要抢救；合并未处置的恶性肿瘤或呼吸系统、心血管系统、肝、肾、造血系统等重大原发疾病。 ③去骨瓣减压术后或其他颅骨缺损者。 ④弱势群体，包括精神疾病者、危重患者、视听障碍者、孕妇。 ⑤其他不能配合完成试验的情况。

Exclusion criteria：

① Dysphagia caused by non-cerebrovascular accident, such as motor neuron disease, head and neck tumor surgery, muscle disease, etc. ② Important organ failure, or critical condition requiring rescue; Combined with untreated malignant tumors or major primary diseases of the respiratory system, cardiovascular system, liver, kidney, hematopoietic system, etc. ③ after decompressive craniectomy or other skull defects. (4) vulnerable groups, including people with mental illness, critically ill patients, people with visual and hearing impairment, and pregnant women. ⑤ other situations that cannot cooperate with the completion of the test.

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2025-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-11-01 00:00:00 至 To 2025-09-30 00:00:00  

干预措施：

Interventions：

组别：

卒中后吞咽障碍组

样本量：

25

Group：

PSD group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

none

Intervention code：

组别：

卒中后非吞咽障碍组

样本量：

25

Group：

NPSD group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

none

Intervention code：

组别：

健康对照组

样本量：

25

Group：

Healthy control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

none

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

 杭州 

Country：

China 

Province：

Zhejiang 

City：

Hangzhou 

单位(医院)：

浙江大学医学院附属邵逸夫医院  

单位级别：

三甲 

Institution
hospital：

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

大脑皮层血氧浓度

指标类型：

主要指标

Outcome：

Blood oxygen concentration in the cerebral cortex

Type：

Primary indicator

测量时间点：

测量方法：

近红外脑功能成像

Measure time point of outcome：

Measure method：

fNIRS

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 30 岁 years
最大 Max age 85 岁 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）：

无

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

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）：

发表文章后

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

After publishing the paper

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：

CRF

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

CRF

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：

  2024-10-16 16:11:00