ChiCTR2600119523 版本V1.0 版本创建时间2026/02/28 10:31:29 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：

 ChiCTR2600119523 

最近更新日期：

Date of Last Refreshed on：

 2026-02-28 10:31:24 

注册时间：

Date of Registration：

 2026-02-28 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于脑电信号构建PSCI的预测模型及tACS刺激百会-神庭穴的机制研究

Public title：

Developing an EEG-Based Predictive Model for Post-Stroke Cognitive Impairment and Investigating the Mechanisms of tACS Stimulation at Baihui (GV20) and Shenting (GV24) Acupoints

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于脑电信号构建PSCI的预测模型及tACS刺激百会-神庭穴的机制研究

Scientific title：

Developing an EEG-Based Predictive Model for Post-Stroke Cognitive Impairment and Investigating the Mechanisms of tACS Stimulation at Baihui (GV20) and Shenting (GV24) Acupoints

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：

王鑫洋 

研究负责人：

王鑫洋  

Applicant：

Xinyang Wang 

Study leader：

Xinyang Wang 

申请注册联系人电话：

Applicant telephone：

 +86 150 8046 6189

研究负责人电话：

Study leader's
telephone：

+86 150 8046 6189

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：

 1398753469@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1398753469@qq.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：

福建省福州市鼓楼区湖东支路13号福建中医药大学附属康复医院

研究负责人通讯地址：

福建省福州市鼓楼区湖东支路13号福建中医药大学附属康复医院

Applicant address：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, No. 13 Hudong Branch Road, Gu Lou District, Fuzhou, Fujian

Study leader's address：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, No. 13 Hudong Branch Road, Gu Lou District, Fuzhou, Fujian

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：

福建中医药大学附属康复医院

Applicant's institution：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

研究负责人所在单位：

福建中医药大学附属康复医院

Affiliation of the Leader：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

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：

 2025YJS-035-02

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：

福建中医药大学附属康复医院伦理审查委员会

Name of the ethic committee：

Ethical Review Committee of Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-06-13 00:00:00

伦理委员会联系人：

管祖汾

Contact Name of the ethic committee：

Zufen Guan

伦理委员会联系地址：

福建省福州市鼓楼区湖东支路13号福建中医药大学附属康复医院

Contact Address of the ethic committee：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, No. 13 Hudong Branch Road, Gu Lou District, Fuzhou, Fujian

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 591 8852 9126

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：

福建中医药大学附属康复医院

Primary sponsor：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

福建中医药大学附属康复医院

Primary sponsor's address：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建

市(区县)：

Country：

China

Province：

Fujian

City：

单位(医院)：

福建中医药大学附属康复医院

具体地址：

福建省福州市鼓楼区湖东支路13号福建中医药大学附属康复医院

Institution
hospital：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Address：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, No. 13 Hudong Branch Road, Gu Lou District, Fuzhou, Fujian

经费或物资来源：

福建省认知功能康复重点实验室开放课题

Source(s) of funding：

The Open project of Fujian Key Laboratory of Cognitive Function Rehabilitation

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）通过机器学习分析脑电指标，探索卒中后认知障碍（PSCI）患者、卒中后无认知障碍（PSN）与健康人群(HC)的神经电生理差异。旨在确定特征性神经电生理标志和诊断指标，并构建和验证可视化临床预测模型以分辨PSCI。 （2）探讨tACS刺激百会-神庭穴在改善PSCI患者的认知功能的临床疗效及其神经电生理机制研究。  

Objectives of Study：

(1) To explore the neurophysiological differences between patients with post-stroke cognitive impairment (PSCI), post-stroke no cognitive impairment (PSN) and healthy population (HC) by analysing EEG metrics through machine learning. The aim is to identify characteristic neurophysiological markers and diagnostic indicators, and to construct and validate visual clinical prediction models to discriminate PSCI. (2) To investigate the clinical efficacy of tACS stimulation of Baihui-Shenting acupoints in improving cognitive function in patients with PSCI and its neuroelectrophysiological mechanism study.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

研究一： （1） PSCI受试者纳入标准 1.　年龄40-75岁； 2.　首次发生脑卒中（出血／梗死）者，病程<=6个月； 3.　诊断符合《卒中后认知障碍管理专家共识2021》卒中后认知障碍诊断要点； 4.　MoCA: <26分 5.　能理解、配合本项实验的康复评定； 6.　患者本人或由其直系亲属签署知情同意书。 （2） PSN受试者纳入标准 1. 年龄40-75岁； 2. 首次发生脑卒中（出血／梗死）者，病程<=6个月； 3. MoCA: >=26分 4. 能理解、配合本项实验的康复评定； 5. 患者本人或由其授权委托人同意参与实验并签署知情同意书。 （3） 健康受试者纳入标准 1.　年龄40-80岁； 2.　无脑卒中病史； 3.　MoCA: >= 26分 4.　能理解、配合本项实验的康复评定； 5.　患者本人或由其授权委托人同意参与实验并签署知情同意书 研究二： 1.　 年龄40-75岁； 2.　 首次发生脑卒中（出血／梗死）者，病程<=6个月； 3.　 诊断符合《卒中后认知障碍管理专家共识2021》卒中后认知障碍诊断要点； 4.　 MoCA:<26分 5.　 通过研究二筛查后存在认知障碍的卒中患者 6.　 体内没有金属植入物或起搏器； 7.　 能理解、配合本项实验的康复评定及治疗； 8.　 患者本人或由其直系亲属签署知情同意书。

Inclusion criteria

Study I: (1) Inclusion criteria for PSCI subjects 1. Age 40-75 years old; 2. First stroke (haemorrhage/infarction) with a disease duration of ≤6 months; 3. Diagnosis in accordance with the "Expert Consensus on the Management of Post-Stroke Cognitive Impairment 2021" Diagnostic Points of Post-Stroke Cognitive Impairment; 4. MoCA: <26 points 5. Able to understand and cooperate with the rehabilitation assessment of this experiment; 6. Informed consent signed by the patients themselves or by their immediate family members. (2) Inclusion criteria for PSN subjects 1. Age 40-75 years old; 2. First stroke (haemorrhage/infarction) with a disease duration of ≤6 months; 3. MoCA: >=26 points 4. Able to understand and co-operate with the rehabilitation assessment of this experiment; 5. The patient himself/herself or by his/her authorised delegate agreed to participate in the experiment and signed the informed consent form. (3) Inclusion criteria for healthy subjects 1. Age 40-80 years old; 2. No history of stroke; 3. MoCA: >= 26 points 4. Understand and cooperate with the rehabilitation assessment of the experiment; 5. The patient himself/herself or his/her authorised delegate agrees to participate in the experiment and signs the informed consent form. Study two: 1. Age 40-75 years old; 2. First time stroke (haemorrhage/infarction) patients with a disease duration of ≤ 6 months; 3. Diagnosis was in accordance with the diagnostic points of Post-stroke Cognitive Impairment Diagnostic Points of the Expert Consensus on Management of Post-stroke Cognitive Impairment 2021; 4. MoCA:<26 points. 5. Stroke patients with cognitive impairment after screening by Study 2 6. No metallic implants or pacemakers in the body; 7. Able to understand and cooperate with the rehabilitation assessment and treatment of this experiment; 8. The patient himself/herself or his/her immediate family members signed the informed consent form.

排除标准：

研究一： 1. 由脑肿瘤、老年性痴呆、甲状腺功能减退、脑外伤等原因其它疾病导致认知功能障碍 2. 既往发生过脑卒中而有后遗症患者 3. 意识障碍，严重视力、听力及言语障碍者 4. 发热、电解质紊乱或生命体征不稳定患者 5. 患有严重心、肺、肝、肾等重要脏器功能衰竭患者。 研究二： 1.　由脑肿瘤、老年性痴呆、甲状腺功能减退、脑外伤等原因或其它疾病导致认知功能障碍； 2.　既往发生过腔隙性脑梗塞而有后遗症患者； 3.　有个人或家族癫痫史或精神病史者； 4.　意识障碍，严重视力、听力及言语障碍者； 5.　发热、电解质紊乱或生命体征不稳定患者； 6.　患有严重心、肺、肝、肾等重要脏器功能衰竭患者； 7.　有tACS禁忌证，如皮肤局部损伤或炎症、颅骨缺损、刺激区域有痛觉过敏的患者。

Exclusion criteria：

Study I: 1. Cognitive dysfunction caused by brain tumour, senile dementia, hypothyroidism, traumatic brain injury, and other diseases. 2. Patients with sequelae of previous strokes. 3. Consciousness disorder, severe vision, hearing and speech disorders. 4.Patients with fever, electrolyte disorder or unstable vital signs. 5. Patients with severe heart, lung, liver, kidney and other important organ failure. Study II: 1. Cognitive dysfunction caused by brain tumour, senile dementia, hypothyroidism, traumatic brain injury or other diseases; 2. Patients with sequelae from previous lacunar cerebral infarction; 3. Patients with personal or family history of epilepsy or psychosis; 4. Patients with personal or family history of epilepsy or psychiatric illness; (iv) Patients with impaired consciousness, severe visual, hearing and speech disorders; 5. Patients with fever, electrolyte disorder or unstable vital signs; 6. Patients with fever, electrolyte disorders or unstable vital signs. ⑥ Patients with severe heart, lung, liver, kidney and other important organ failure; 7. Patients with contraindications to tACS, such as localised skin injury or inflammation, cranial defects, or nociceptive hypersensitivity in the stimulated area.

研究实施时间：

Study execute time：

从 From 2025-06-13 00:00:00至 To 2026-06-13 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-15 00:00:00 至 To 2026-06-13 00:00:00

干预措施：

Interventions：

组别：

假刺激组（研究2）

样本量：

 20

Group：

sham-tACS group

Sample size：

干预措施：

该组实施经颅交流电假刺激、常规内科治疗和常规康复功能训练。 1. 经颅交流电假刺激 采用经颅交流电刺激仪（深圳艾利特医疗科技有限公司），电极片直径为4 cm。将两个电极片分别放置于百会和神庭。该装置放置在患者身后，以确保患者不知道干预的具体频率参数。电流强度为2mA，开启假刺激模式（电流在前15s上升至2mA，然后回落，在20分钟内保持在0mA）。每天1次，每次20分钟，每周治疗5天，共4周。 2. 常规内科治疗 依据2022年中华医学会神经病学分会脑血管病学组制定的《中国缺血性脑卒中和短暂性脑缺血发作二级预防指南 2022》和2019年中华医学会神经病学分会脑血管病学组制定的《中国脑出血诊治指南（2019）》对入组的受试者实施常规内科治疗，具体包括病因的处理、血压管理、抗血小板、抗凝治疗、合并心脏病的基础治疗、高半胱氨酸血症的治疗、血糖、血脂的管理等。 3. 常规康复功能训练 根据患者的具体病情，参照2017年中华医学会神经病学分会制定的《中国脑卒中早期康复治疗指南》进行运动疗法、作业疗法、ADL功能训练等综合康复训练，30min/次，每周治疗5天，1日1次，疗程为4周。

干预措施代码：

Intervention：

Transcranial alternating current (TAC) sham stimulation, conventional medical treatment and conventional rehabilitative functional training were implemented in this group. 1. Transcranial alternating current pseudostimulation A transcranial alternating current stimulator (Shenzhen Ailite Medical Technology Co., Ltd.) was used, with electrode pads of 4 cm in diameter, and two electrode pads were placed at Baihui and Shenting respectively. The device was placed behind the patient to ensure that the patient was not aware of the specific frequency parameters of the intervention. The current intensity was 2 mA, and the sham stimulation mode was switched on (the current rose to 2 mA in the first 15 s, then fell back and remained at 0 mA for 20 min). The treatment was performed once a day for 20 min, 5 days a week for 4 weeks. 2. Conventional medical treatment Based on the "Chinese Guidelines for Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack 2022" developed by the Cerebrovascular Disease Group of the Neurology Section of the Chinese Medical Association in 2022 and the "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Haemorrhage (2019)" developed by the Cerebrovascular Disease Group of the Neurology Section of the Chinese Medical Association in 2019, the enrolled subjects were administered conventional internal medicine treatment, which specifically included treatment of the cause of the disease, blood pressure management, antiplatelet and anticoagulant therapy, basic treatment of comorbid heart disease, treatment of homocysteinemia, and management of blood glucose and lipid. 3. Routine rehabilitation functional training According to the specific condition of the patient, comprehensive rehabilitation training such as exercise therapy, occupational therapy, ADL functional training, etc., was carried out with reference to the Chinese Guidelines for Early Rehabilitation Treatment of Stroke formulated by the Neurology Section of the Chinese Medical Association in 2017, and 30 min/times were given 5 days of treatment per week, once a day, and the course of treatment was 4 weeks.

Intervention code：

组别：

经颅交流电组（研究2）

样本量：

 20

Group：

tACS group

Sample size：

干预措施：

实验组1进行百会-神庭经颅交流电刺激、常规内科治疗和常规康复功能训练。 1. 基础治疗和常规康复功能训练同对照组。 2. 百会-神庭经颅交流电刺激 采用经颅交流电刺激仪（深圳艾利特医疗科技有限公司），电极片直径为4 cm。将两个电极片分别放置于百会和神庭。该装置放置在患者身后，以确保患者不知道干预的具体频率参数。电流强度为2mA，频率为10Hz，每1次，每次20分钟，每周治疗5天，共4周。

干预措施代码：

Intervention：

Experimental group 1 underwent Baihui-Shenting transcranial alternating current stimulation, conventional internal medicine treatment, and conventional rehabilitation function training. 1. Basic treatment and routine rehabilitation functional training were the same as the control group. 2. Baihui - Shenting transcranial alternating current stimulation A transcranial alternating current stimulator (Shenzhen Ailite Medical Technology Co., Ltd.) was used, with electrodes of 4 cm in diameter, and two electrodes were placed in Baihui and Shenting respectively. The device was placed behind the patient to ensure that the patient was not aware of the specific frequency parameters of the intervention. The current intensity was 2 mA and the frequency was 10 Hz for 1 session of 20 min each, with 5 days of treatment per week for 4 weeks.

Intervention code：

组别：

电针刺激组（研究2）

样本量：

 20

Group：

Electroacupuncture group

Sample size：

干预措施：

实验组2进行电针百会-神庭刺激、常规内科治疗和常规康复功能训练。 1. 基础治疗和常规康复功能训练同对照组。 2. 电针刺激 使用一次性针头（0.35 毫米 × 40 毫米，华佗，苏州，中国）的插入百会和神庭穴，深度约为 0.3–0.5 寸。插入后，针灸师提插捻转 1 分钟。在达到“得气”（酸痛、刺痛或肿胀的感觉）后，将每个穴位的针连接到电子针灸治疗仪（无锡佳健医疗器械股份有限公司），以提供电刺激。该装置放置在患者身后，以确保患者不知道干预的具体频率参数。电流强度取决于受试者的耐受性的情况下取1-2mA，最好是穴位周围的皮肤轻微颤抖而不感到疼痛。频率为10Hz,电针治疗持续 20 分钟，电流频率为 10 Hz，波形为连续波。每天1次，每次20分钟，每周治疗5天，共4周。

干预措施代码：

Intervention：

Experimental group 2 underwent electroacupuncture Baihui-Shenting stimulation, conventional internal medicine treatment and conventional rehabilitation functional training. 1. Basic treatment and routine rehabilitation functional training were the same as the control group. 2. Electroacupuncture stimulation Disposable needles (0.35 mm × 40 mm, Hua Tuo, Suzhou, China) were inserted into the Baihui and Shenting points to a depth of approximately 0.3-0.5 inch. After insertion, the acupuncturist lifted and twisted the needles for 1 minute. After achieving "qi" (a sensation of soreness, tingling, or swelling), needles at each point were connected to an electronic acupuncture device (Wuxi Jiajian Medical Equipment Co., Ltd.) to provide electrical stimulation. The device was placed behind the patient to ensure that the patient was not aware of the specific frequency parameters of the intervention. The current intensity was taken as 1-2 mA depending on the subject's tolerance, preferably with a slight shivering of the skin around the acupuncture point without pain. The frequency was 10 Hz,Electroacupuncture treatment lasted for 20 minutes and the current frequency was 10 Hz with continuous waveform. The treatment was carried out once a day for 20 minutes, 5 days a week for 4 weeks.

Intervention code：

组别：

PSCI组（研究1）

样本量：

 70

Group：

PSCI group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

none

Intervention code：

组别：

PSN组（研究1）

样本量：

 46

Group：

PSN 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（研究1）

样本量：

 46

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)：

 福建 

市(区县)：

  

Country：

China

Province：

Fujian

City：

单位(医院)：

 福建中医药大学附属康复医院 

单位级别：

 三甲 

Institution
hospital：

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

蒙特利尔认知评估量表

指标类型：

主要指标

Outcome：

Montreal Cognitive Assessment (MoCA)

Type：

Primary indicator

测量时间点：

治疗前后1天内

测量方法：

Measure time point of outcome：

Within 1 day before and after treatment

Measure method：

指标中文名：

数字广度测试

指标类型：

次要指标

Outcome：

Digit Span Test

Type：

Secondary indicator

测量时间点：

治疗前后1天内

测量方法：

Measure time point of outcome：

Within 1 day before and after treatment

Measure method：

指标中文名：

复杂图形测试

指标类型：

次要指标

Outcome：

Rey-Osterrieth Complex Figure Test (ROCF)

Type：

Secondary indicator

测量时间点：

治疗前后1天内

测量方法：

Measure time point of outcome：

Within 1 day before and after treatment

Measure method：

指标中文名：

连线测试A/B

指标类型：

次要指标

Outcome：

Trail Making Test A/B(TMT)

Type：

Secondary indicator

测量时间点：

治疗前后1天内

测量方法：

Measure time point of outcome：

Within 1 day before and after treatment

Measure method：

指标中文名：

静息态脑电图

指标类型：

主要指标

Outcome：

Resting-State Electroencephalography (EEG)

Type：

Primary indicator

测量时间点：

治疗前后1天内

测量方法：

Measure time point of outcome：

Within 1 day before and after treatment

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

 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 40 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）：

本研究的随机化序列由本研究的统计人员使用 Microsoft Excel 中的随机数生成函数生成。按照各组等比例随机分组，将PSCI受试者分为治疗组和对照组。首先由RAND函数对每个PSCI受试者生成15位的随机小数；而后使用RANK函数得到随机小数的大小排序，再将60个样本量除以20并使用Roundup函数向上取整，则会得到每个人的组别1或2或3。参与者根据生成的随机数1：1：1的比例分配到假刺激组、穴位刺激tACS干预组、前额叶tACS中。为保持随机化过程的完整性，参与生成随机分配序列的人员不参与参与者招募，将自行打印并保留随机分组的结果。

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

The randomisation sequence for this study was generated by the statistician of this study using the random number generation function in Microsoft Excel. The PSCI subjects were divided into treatment and control groups according to the equal proportional randomisation of the groups. A 15-digit random decimal was first generated for each PSCI subject by the RAND function; and then the RANK function was used to obtain the size ordering of the random decimals, and then dividing the sample size of 60 by 20 and rounding upwards using the Roundup function would result in a group 1 or 2 or 3 for each individual.Participants were assigned to the sham-stimulation group, acupoint stimulation group, prefrontal stimulation group, control group, and treatment group in the 1:1:1 ratio according to the generated random numbers. tACS intervention group, and prefrontal tACS. To maintain the integrity of the randomisation process, the person involved in generating the random allocation sequence will not be involved in participant recruitment and will print and retain the results of the random grouping themselves.

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：

本研究对受试者、干预者、评估者和统计员均设盲，以确保公正性。符合条件的受试者以 1:1:1的比例随机分配到两个实验组或对照组。随机化代码由未参与干预、评估或统计分析的研究人员安全管理。盲法过程涉及三个级别的编码：第一个盲码将每个组标记为“A”或“B”或”C”，而第二个盲码揭示了这些标签的实际含义，表明“A”或“B” 或”C”对应于治疗组还是对照组。

Blinding：

The study was blinded to subjects, interveners, assessors and statisticians to ensure impartiality. Eligible subjects were randomly assigned to two experimental or control groups in a 1:1:1 ratio. Randomisation codes were securely managed by researchers not involved in the intervention, assessment or statistical analysis. The blinding process involved three levels of coding: the first blinded code labelled each group as "A" or "B" or "C", while the second blinded code revealed the actual meaning of these labels, indicating that the "A" or "B" group had been randomised to the two experimental groups. It indicates whether "A" or "B" or "C" corresponds to the treatment or control group.

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

是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）：

2026/07/01后通过国家生物信息中心 https://ngdc.cncb.ac.cn/gsub/提供原始数据查询

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

After 2026/07/01, China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/) will be provided with raw data query

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：

采用病例记录表进行数据采集和管理

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

Data collection and management were carried out with case record form

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：

  2026-02-28 10:31:24