ChiCTR2600125703 版本V1.0 版本创建时间2026/05/29 15:35:16 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：

 ChiCTR2600125703 

最近更新日期：

Date of Last Refreshed on：

 2026-05-29 15:35:11 

注册时间：

Date of Registration：

 2026-05-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经颅聚焦超声对卒中后患者认知障碍的疗效验证：基于近红外脑成像研究

Public title：

Efficacy validation of transcranial focused ultrasound for cognitive impairment in post-stroke patients: a near-infrared brain imaging study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经颅聚焦超声对卒中后患者认知障碍的疗效验证：基于近红外脑成像研究

Scientific title：

Efficacy validation of transcranial focused ultrasound for cognitive impairment in post-stroke patients: a near-infrared brain imaging study

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：

梁智蓉 

研究负责人：

王丛笑 

Applicant：

Liang Zhirong 

Study leader：

Wang Congxiao 

申请注册联系人电话：

Applicant telephone：

 +86 138 7458 8140

研究负责人电话：

Study leader's
telephone：

+86 189 1033 7178

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：

 liangzhirong597@163.com

研究负责人电子邮件：

Study leader's E-mail：

 wangcongxiao66@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：

北京市石景山区八大处西下庄

研究负责人通讯地址：

北京市石景山区八大处西下庄

Applicant address：

Baogushu West Xiaozhuang, Shijingshan District, Beijing

Study leader's address：

Baogushu West Xiaozhuang, Shijingshan District, Beijing

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：

首都医科大学附属北京康复医院

Applicant's institution：

Beijing Rehabilitation Hospital,Capital Medical University

研究负责人所在单位：

首都医科大学附属北京康复医院

Affiliation of the Leader：

Beijing Rehabilitation Hospital,Capital Medical 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：

 北康科研伦理审(2026bkky-006)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：

首都医科大学附属北京康复医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijing Rehabilitation Hospital Affiliated to Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-23 00:00:00

伦理委员会联系人：

王婷

Contact Name of the ethic committee：

Wang Ting

伦理委员会联系地址：

北京市石景山区八大处西下庄

Contact Address of the ethic committee：

Baogushu West Xiaozhuang, Shijingshan District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 5698 1279

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：

首都医科大学附属北京康复医院

Primary sponsor：

Beijing Rehabilitation Hospital,Capital Medical University

研究实施负责（组长）单位地址：

北京市石景山区八大处西下庄

Primary sponsor's address：

Baogushu West Xiaozhuang, Shijingshan District, Beijing

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

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京康复医院

具体地址：

北京市石景山区八大处西下庄

Institution
hospital：

Beijing Rehabilitation Hospital

Address：

Baogushu West Xiaozhuang, Shijingshan District, Beijing

经费或物资来源：

2025年度北京康复医院院内科技发展专项资助清单

Source(s) of funding：

2025 Funding List of the In-House Science and Technology Development Special Program of Beijing Rehabilitation Hospital

研究疾病：

卒中后认知障碍  

Target disease：

Post-stroke cognitive impairment

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.主要目的：验证经颅聚焦超声治疗卒中后认知障碍的疗效，是否提高了患者的认知功能，改善了患者的日常生活活动能力； 2.次要目的：通过fNIRS客观量化经颅聚焦超声对PSCI患者关键脑区功能的修复效应。  

Objectives of Study：

1. Main objective: To verify the efficacy of transcranial focused ultrasound in treating cognitive impairment after stroke, and to determine whether it has improved the cognitive function of patients and enhanced their ability to perform daily activities. 2. Secondary objective: To objectively quantify the repair effect of transcranial focused ultrasound on the functional recovery of key brain regions in patients with post-stroke cognitive impairment through fNIRS.

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.卒中诊断符合《中国各类主要脑血管病诊断要点 2019》，并经头部CT或 MRI检查确诊； 2.PSCI的诊断符合《卒中后认知障碍管理专家共识 2021》诊断标准； 3.年龄>=18岁且<=80岁,性别不限； 4.病程为卒中后2周~6个月； 5.患者或其监护人签署研究知情同意书； 6.MMSE分值: 10 < MMSE < 26。

Inclusion criteria

1. The diagnosis of stroke complies with "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019", and is confirmed by head CT or MRI examination; 2. The diagnosis of PSCI complies with the diagnostic criteria of "Expert Consensus on the Management of Post-stroke Cognitive Impairment 2021"; 3. Age is between 18 years and 80 years (inclusive), and gender is not restricted; 4. The disease course is from 2 weeks to 6 months after stroke; 5. The patient or their guardian has signed the research informed consent form; 6. MMSE score: 10 < MMSE < 26.

排除标准：

1.脑外伤、阿尔茨海默病等非脑卒中引起的认知功能障碍患者； 2.颅骨缺损、植入颅内金属的患者； 3.植入电子设备(如心脏起搏器)的患者； 4.有出血倾向和颅内压升高的患者； 5.怀孕的患者； 6.视听和语言障碍； 7.严重心脏病或其他内科疾病

Exclusion criteria：

1. Patients with cognitive dysfunction caused by non-stroke conditions such as brain trauma and Alzheimer's disease; 2. Patients with skull defects or having implanted metal in the brain; 3. Patients with implanted electronic devices (such as cardiac pacemakers); 4. Patients with bleeding tendencies and elevated intracranial pressure; 5. Pregnant patients; 6. Patients with visual and language impairments; 7. Patients with severe heart diseases or other internal medical conditions.

研究实施时间：

Study execute time：

从 From 2025-12-31 00:00:00至 To 2027-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-29 00:00:00 至 To 2027-03-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 11

Group：

Experimental group

Sample size：

干预措施：

经颅聚焦超声联合常规认知康复训练

干预措施代码：

Intervention：

Transcranial focused ultrasound combined with conventional cognitive rehabilitation training

Intervention code：

组别：

对照组

样本量：

 11

Group：

Control group

Sample size：

干预措施：

常规认知康复训练

干预措施代码：

Intervention：

Conventional cognitive rehabilitation 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)：

 北京康复医院 

单位级别：

 三级 

Institution
hospital：

Beijing Rehabilitation Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

简易精神状态检查

指标类型：

主要指标

Outcome：

Mini-mental state examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

蒙特利尔认知评估

指标类型：

主要指标

Outcome：

Montreal cognitive assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

卒中专用抑郁量表

指标类型：

次要指标

Outcome：

Stroke-Specific Depression Scale

Type：

Secondary 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：

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 18 岁 years
最大 Max age 80 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）：

本研究采用区组随机化方法将22例患者按1:1分配至试验组（经颅聚焦超声联合常规认知康复训练）和对照组（假刺激联合常规认知康复训练）。随机序列由统计软件生成，区组大小为4（末区组调整为6以确保总例数平衡）。分配隐藏采用按顺序编号的不透光密封信封：信封由不参与治疗与评估的第三方按入组顺序依次打开，依据纸条内容通知治疗师执行真实或假刺激。患者、评估者（认知评估及fNIRS操作分析人员）及数据分析者均不知晓分组情况。假刺激组使用同一台设备，仅关闭超声输出而保留运行状态及界面显示，以维持盲法。该方案操作简便、符合双盲原则，可有效避免选择偏倚。

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

This study adopts a block randomization method to allocate 22 patients in a 1:1 ratio to the experimental group (transcranial focused ultrasound combined with conventional cognitive rehabilitation training) and the control group (sham stimulation combined with conventional cognitive rehabilitation training). The randomization sequence is generated using statistical software, with a block size of 4 (the final block is adjusted to 6 to ensure balanced total sample size). Allocation concealment is achieved using sequentially numbered, opaque, sealed envelopes: the envelopes are opened in order by a third party who is not involved in treatment or assessment, and based on the paper slip inside, the therapist is informed to deliver real or sham stimulation. Patients, assessors (those performing cognitive assessments and fNIRS operation/analysis), and data analysts are all blinded to group allocation. In the sham stimulation group, the same device is used, with only the ultrasound output turned off while the operational status and display interface are maintained to preserve blinding. This scheme is easy to implement, meets double-blind requirements, and effectively avoids selection bias

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

无

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

None

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：

1.病例报告表（CRF）：根据研究方案设计标准化的CRF，内容包括患者人口学信息、纳入/排除标准记录、各评估时点的疗效指标（MMSE、MoCA、FIM、PSDS）及安全性记录。CRF由经过培训的研究者在每次访视时当场填写，填写完成后由另一位研究者进行核对，确保数据完整、准确。 2.数据采集：采用纸质病例报告表（CRF）收集数据，并由双人独立录入Excel数据库，通过双录入比对和范围核查确保数据准确性。数据库保存在医院内网加密服务器中，仅授权人员可访问。所有数据修改均记录在案。所有数据修改均保留审计追踪记录。 3.数据安全与隐私保护：患者数据以匿名化编码标识，不包含姓名、身份证号等个人可识别信息。数据库访问权限仅授予课题组成员，且通过密码保护。 4.数据锁定：全部数据录入并清理完毕后，由项目负责人和科研管理部共同审核锁定数据库，锁定后不可更改，用于最终统计分析。

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

1. Case Report Form (CRF): A standardized CRF is designed according to the research protocol, covering patient demographic information, inclusion/exclusion criteria records, efficacy indicators at each assessment point (MMSE, MoCA, FIM, PSDS) and safety records. The CRF is filled out on the spot by trained researchers during each visit, and then checked by another researcher to ensure the completeness and accuracy of the data. 2. Data collection: Data is collected using paper-based CRFs and entered independently by two individuals into an Excel database. The accuracy of the data is ensured through double-entry comparison and range verification. The database is stored in an encrypted server on the hospital intranet and can only be accessed by authorized personnel. All data modifications are recorded. Audit tracking records of all data modifications are retained. 3. Data security and privacy protection: Patient data is anonymized and encoded, and does not contain personal identifiable information such as names and ID numbers. Database access rights are granted only to members of the research team, and are protected by passwords. 4. Data locking: After all data has been entered and cleaned, the database is jointly reviewed and locked by the project leader and the research management department. Once locked, the data cannot be modified and is used for final statistical analysis.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-05-29 15:35:11