ChiCTR2600120914 版本V1.0 版本创建时间2026/03/23 09:57:03 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：

 ChiCTR2600120914 

最近更新日期：

Date of Last Refreshed on：

 2026-03-23 09:56:58 

注册时间：

Date of Registration：

 2026-03-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

β-γ跨频耦合tACS调制M1兴奋性改善卒中幸存者上肢运动功能：一项双盲、安慰剂控制、随机对照研究

Public title：

β-γ cross-frequency coupling tACS regulate the M1 excitability to improve upper-limb motor function of stroke survivors: a double-blinded, sham-controlled, randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

β-γ跨频耦合tACS调制M1兴奋性改善卒中幸存者上肢运动功能：一项双盲、安慰剂控制、随机对照研究

Scientific title：

β-γ cross-frequency coupling tACS regulate the M1 excitability to improve upper-limb motor function of stroke survivors: a double-blinded, sham-controlled, randomized controlled trial

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：

强乙 

研究负责人：

秦蓓英 

Applicant：

Yi Qiang 

Study leader：

Beiying Qin 

申请注册联系人电话：

Applicant telephone：

 +86 139 1746 1165

研究负责人电话：

Study leader's
telephone：

+86 137 6447 9932

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：

 8446687@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 334513641@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：

中国上海市静安区芷江中路274号

研究负责人通讯地址：

中国上海市静安区芷江中路274号

Applicant address：

274 Zhijiang Zhong Lu, Jing 'an District, Shanghai, China

Study leader's address：

274 Zhijiang Zhong Lu, Jing 'an District, Shanghai, 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：

上海市中医医院

Applicant's institution：

Shanghai Municipal Hospital of Traditional Chinese Medicine

研究负责人所在单位：

上海市中医医院

Affiliation of the Leader：

Shanghai Municipal Hospital 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：

 2025SHL-KY-31-06

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：

上海市中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Municipal Hospital of Tranditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-10 00:00:00

伦理委员会联系人：

凌丽

Contact Name of the ethic committee：

Li Ling

伦理委员会联系地址：

中国上海市静安区芷江中路274号

Contact Address of the ethic committee：

274 Zhijiang Zhong Lu, Jing 'an District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 5662 8310

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 shszyyyec@126.com

研究实施负责（组长）单位：

上海市中医医院

Primary sponsor：

Shanghai Municipal Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

中国上海市静安区芷江中路274号

Primary sponsor's address：

274 Zhijiang Zhong Lu, Jing 'an District, Shanghai, 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市中医医院

具体地址：

中国上海市静安区芷江中路274号

Institution
hospital：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Address：

274 Zhijiang Zhong Lu, Jing 'an District, Shanghai, China

经费或物资来源：

自筹

Source(s) of funding：

Raise independently

研究疾病：

脑卒中  

Target disease：

Stroke

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：

中风后恢复上肢功能仍然具有高度挑战性。基于β，γ振荡在运动控制和交叉频率耦合（cross-frequency coupling，CFC）中占主导地位的证据，β-γCFC-tACS可能是一种改善脑卒中后上肢功能的新型有效康复技术，但尚未得到临床研究的证实。本研究旨在探讨β-γ交频耦合tACS对脑卒中患者上肢运动功能的影响。  

Objectives of Study：

Recovering upper‐limb function after a stroke remains highly challenging. Building on the evidence of β, γ oscillation dominate in motor control and the cross-frequency coupling (CFC), β-γ CFC tACS may be a novel and effective rehabilitation technology for improve post-stroke upper-limb function, yet not been confirmed by clinical studies. The purpose of the present study was aimed to explore the effects of β-γ cross-frequency coupling tACS on upper-limb motor function of stroke survivors.

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） 临床诊断为脑出血或经CT/MRI证实的脑梗死； （2）45-75岁； （3）首次脑卒中，发病时间≤3个月； （4）单侧右侧或左侧卒中伴上肢运动障碍； （5）无认知障碍（简易精神状态检查评分>24分）； （6）签署知情同意书。

Inclusion criteria

(1) the clinical diagnosis was cerebral hemorrhage or cerebral infarction confirmed by CT / MRI; (2) 45-75 years old; (3) the first-ever stroke, and the time of since stroke onset <= 3 months; (4) unilateral right or left sided stroke with upper-limb motor disorders; (5) without cognitive disorders (Mini-Mental State Examination score > 24); (6) signed informed consent.

排除标准：

（1） 诊断任何其他神经疾病，包括抑郁症、严重语言理解缺陷、单侧空间忽视、癫痫、上肢失用症等。； （2）有任何活动的、不受控制的心血管或骨科疾病； （3）上肢周围神经病变严重； （4）有严重肩痛或腕、手指挛缩； （5）头部植入金属或植入心脏起搏器； （6）结合tACS和经颅磁刺激（TMS）的禁忌证； （7）目前正在参加任何其他临床研究或教练指导的锻炼计划.

Exclusion criteria：

(1) Diagnosis of any other neurological conditions, including depression, severe language comprehension deficits, unilateral spatial neglect, epilepsy, upper-limb apraxia, etc.; (2) With any active uncontrolled cardiovascular, or orthopedic condition; (3) Exhibit substantial peripheral neuropathy in the upper limb; (4) Had severe shoulder pain or wrist and finger contractures; (5) Implanted metal in the head or implanted cardiac pacemaker; (6) Combined with some contraindications to tACS and Transcranial Magnetic Stimulation (TMS); (7) Currently participating in any other clinical study or coach directed exercise program

研究实施时间：

Study execute time：

从 From 2026-02-04 00:00:00至 To 2027-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-29 00:00:00 至 To 2027-08-31 00:00:00

干预措施：

Interventions：

组别：

假刺激组

样本量：

 25

Group：

Sham-stimulation group

Sample size：

干预措施：

卒中后上肢运动恢复的常规康复训练将采用以神经可塑性为中心的多模式方法，包括被动和主动肢体运动、本体感觉神经肌肉促进、肌肉强化、神经肌肉电刺激（NMES）、约束诱导运动疗法（CIMT）、机器人辅助治疗和任务导向训练，干预时长20min。tACS假刺激程序将使用相同的电极拼接和设备设置。假刺激将以短暂的低强度电流斜坡（仅30秒）开始，以复制初始皮肤感觉。干预时长20min。

干预措施代码：

Intervention：

CRP for upper limb motor recovery post-stroke will be employing a multi-modal approach centered on neuroplasticity, which will be included passive and active limbs movement, proprioceptive neuromuscular facilitation, muscle strengthening, neuromuscular electrical stimulation (NMES), constraint-induced movement therapy (CIMT), robotic-assisted therapy and task-oriented training. The intervention lasted for 20min. The sham-stimulation procedure will utilize an identical electrode montage and device setup. The sham stimulation will initiate with a brief, low-intensity current ramp (only 30 seconds) to replicate the initial cutaneous sensation. The intervention lasted for 20min.

Intervention code：

组别：

β-tACS组

样本量：

 25

Group：

β-stimulation group

Sample size：

干预措施：

实施常规康复训练+β-tACS，20min+20min。常规康复训练同上组。TAC由NeuroConn DC刺激器通过一对盐水浸泡的矩形海绵电极（5×7 cm）提供，该电极符合先前使用的标准蒙太奇。根据国际10-20 EEG系统（M1位于C3，返回电极位于Fp2上方），电极将放置在患侧初级运动皮层（M1）和对侧眶上区。参数设置如下：波形：正弦； 持续时间：20分钟（包括30秒爬升/爬降）； 电流强度：1.0 mA峰间，0.02857 mA/cm2； 皮肤准备和阻抗监测将确保阻抗<10 kΩ；刺激频率20Hz。

干预措施代码：

Intervention：

Routine rehabilitation training+β - TACs, 20min+20min. The routine rehabilitation training was the same as the above group. TAC was provided by neuroconn DC stimulator through a pair of saline soaked rectangular sponge electrodes (5 × 7 cm), which met the standard montage used previously. According to the international 10-20 EEG system (M1 is located at C3 and the return electrode is located above FP2), the electrode will be placed in the primary motor cortex (M1) of the affected side and the contralateral supraorbital area. The parameter settings are as follows: waveform: sine; Duration: 20 minutes (including 30 second climb/descent); Current intensity: 1.0 Ma peak to peak, 0.02857 ma/cm 2; Skin preparation and impedance monitoring will ensure that the impedance is<10 K Ω; the stimulation frequency is 20Hz.

Intervention code：

组别：

γ-tACS组

样本量：

 25

Group：

γ-stimulation group

Sample size：

干预措施：

实施常规康复训练+β-tACS，20min+20min。常规康复训练同上组。TAC由NeuroConn DC刺激器通过一对盐水浸泡的矩形海绵电极（5×7 cm）提供，该电极符合先前使用的标准蒙太奇。根据国际10-20 EEG系统（M1位于C3，返回电极位于Fp2上方），电极将放置在患侧初级运动皮层（M1）和对侧眶上区。参数设置如下：波形：正弦； 持续时间：20分钟（包括30秒爬升/爬降）； 电流强度：1.0 mA峰间，0.02857 mA/cm2； 皮肤准备和阻抗监测将确保阻抗<10 kΩ；刺激频率60Hz。

干预措施代码：

Intervention：

Routine rehabilitation training+β - TACs, 20min+20min. The routine rehabilitation training was the same as the above group. TAC was provided by neuroconn DC stimulator through a pair of saline soaked rectangular sponge electrodes (5 × 7 cm), which met the standard montage used previously. According to the international 10-20 EEG system (M1 is located at C3 and the return electrode is located above FP2), the electrode will be placed in the primary motor cortex (M1) of the affected side and the contralateral supraorbital area. The parameter settings are as follows: waveform: sine; Duration: 20 minutes (including 30 second climb/descent); Current intensity: 1.0 Ma peak to peak, 0.02857 ma/cm 2; Skin preparation and impedance monitoring will ensure that the impedance is<10 K Ω; the stimulation frequency is 60Hz.

Intervention code：

组别：

β-γ tCS组

样本量：

 25

Group：

β-γ coupling stimulation group

Sample size：

干预措施：

实施常规康复训练+β-tACS，20min+20min。常规康复训练同上组。TAC由NeuroConn DC刺激器通过一对盐水浸泡的矩形海绵电极（5×7 cm）提供，该电极符合先前使用的标准蒙太奇。根据国际10-20 EEG系统（M1位于C3，返回电极位于Fp2上方），电极将放置在患侧初级运动皮层（M1）和对侧眶上区。参数设置如下：波形：正弦； 持续时间：20分钟（包括30秒爬升/爬降）； 电流强度：1.0 mA峰间，0.02857 mA/cm2； 皮肤准备和阻抗监测将确保阻抗<10 kΩ；刺激频率为20-60耦合频率。

干预措施代码：

Intervention：

Routine rehabilitation training+β - TACs, 20min+20min. The routine rehabilitation training was the same as the above group. TAC was provided by neuroconn DC stimulator through a pair of saline soaked rectangular sponge electrodes (5 × 7 cm), which met the standard montage used previously. According to the international 10-20 EEG system (M1 is located at C3 and the return electrode is located above FP2), the electrode will be placed in the primary motor cortex (M1) of the affected side and the contralateral supraorbital area. The parameter settings are as follows: waveform: sine; Duration: 20 minutes (including 30 second climb/descent); Current intensity: 1.0 Ma peak to peak, 0.02857 ma/cm 2; Skin preparation and impedance monitoring will ensure that the impedance is<10 K Ω; the stimulation frequency is 20-60 coulping frequency.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海市中医医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

上肢运动功能

指标类型：

主要指标

Outcome：

Upper-limb motor function

Type：

Primary indicator

测量时间点：

干预前，8周，随访3个月

测量方法：

Fugl-Meyer Assessment Scale

Measure time point of outcome：

Pre-intervention, 8 weeks and 3 mouths

Measure method：

Fugl-Meyer Assessment Scale

指标中文名：

不良事件发生率

指标类型：

主要指标

Outcome：

Incidence rate of adverse events

Type：

Primary indicator

测量时间点：

干预前,8周，随访3个月

测量方法：

在干预及其后续阶段发生的所有不良事件（如不耐受、皮肤相关疼痛或瘙痒）将通过参与者自我报告记录在病例报告表（CRF）中。然后对每个报告的事件进行评估，以确定其与干预的关系。各组不良事件的发生率定义为经历至少一次此类事件的参与者人数除以该组参与者总数。

Measure time point of outcome：

Pre-intervention, 8 weeks and 3 mouths

Measure method：

All adverse events (e.g., intolerance, skin-related pain, or itching) arising during the intervention and its follow-up phase will be documented on the Case Report Form (CRF) through participant self-reports. Each reported event will then be assessed to determine its relationship to the intervention. The incidence rate of adverse events in each group is defined as the number of participants who experience at least one such event divided by the total number of participants in that group.

指标中文名：

皮质脊髓兴奋性

指标类型：

次要指标

Outcome：

Corticospinal excitability

Type：

Secondary indicator

测量时间点：

干预前，8周，随访3个月

测量方法：

MEPs使用八线圈数字TMS装置进行评估。基于10–20 EEG系统的定位帽将用于确定M1。将线圈切向手持式放置在受影响M1上方，手柄朝向后前方，与颅骨中线矢状面成45度角。记录第一背侧骨间肌肌电活动。静息运动阈值（RMT）是指诱发50μV MEP所需的最低TMS强度。单脉冲TMS的强度为120%RMT。考虑到TMS诱发MEP振幅的内在变异性，受靶肌肉、背景活动、线圈定位、刺激强度和脉间间隔等因素的影响，先前的研究确保了至少20–30 MEP的可靠性。因此，记录30个MEP的PPA和AUC，用于MEP评估和分析。

Measure time point of outcome：

Pre-intervention, 8 weeks and 3 mouths

Measure method：

MEPs was assessed using TMS device with a figure-of-eight Coil in the present protocol. The positioning cap based on the 10–20 EEG system will be used to determine the M1. The coil was tangentially handheld positioned over the affected M1, with the handle oriented in a posterior-anterior direction at 45 deg from the midline sagittal plane of the skull. EMG activity was recorded from the first dorsal interosseous (FDI) muscle. Resting motor threshold (RMT) refers

指标中文名：

皮质-肌肉相干性

指标类型：

次要指标

Outcome：

Corticomuscular coherence

Type：

Secondary indicator

测量时间点：

干预前，8周，随访3个月

测量方法：

要求受试者坐在一张桌子前，肩关节屈曲80°，内旋90°，患肢主动屈肘10次，每次间隔30s。根据10-20系统（ANT Neuro，Hengelo Netherlands），使用32通道干电极帽记录EEG信号，采样频率为1000 Hz。根据SENIAM项目指南，在用酒精清洁皮肤后，放置三个肌电传感器，以去除死皮颗粒和油残留物，分别放置肱三头肌（TB，肘伸肌）、肱二头肌（BB，肘屈肌）和肱桡肌（BR，肘屈肌）。采用美国Noraxon公司的无线表面肌电采集系统记录肌电信号，采样频率为1000 Hz。EEG记录将通过外部触发的方式与EMG记录同步。EEG、EMG信号预处理和CMC计算将使用MATLAB软件（MathWorks，Natick，MA，USA）和基于MATLAB的工具箱EEGLAB进行。大量研究对脑电和肌电信号预处理的核心步骤和参数选择进行了详细的描述，包括滤波、插值、伪影去除、历元、基线校正、快速傅立叶变换等。

Measure time point of outcome：

Pre-intervention, 8 weeks and 3 mouths

Measure method：

The participants will be asked to seat in front of a table with 80° shoulder flexion and 90° internal rotation, will be performed 10 times active elbow extension and flexion for affected upper limb, 30s between each time. EEG signals were recorded using a 32-channel dry electrode cap according to the 10-20 system (ANT Neuro, Hengelo Netherlands), sampling frequency of 1000 Hz. Three EMG sensors were placed triceps brachii (TB, elbow extensor), biceps brachii (BB, elbow flexors) and brachioradial

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 45 岁 years
最大 Max age 75 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）：

采用以卒中类型（出血/梗死）和优势手（左/右）为因素的分层随机分组法，将符合条件的参与者按1:1:1:1的比例随机分为4组。随机数列表将由SPSS软件的随机数生成器（22.0版；IBM Corp.，NY，USA）生成，操作人员为第三方独立机构的统计人员。

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

The stratified randomization with stroke types (hemorrhage/infarction) and dominant hand (left/right) as factors will be used to randomly assigned the eligible participants to 4 groups in a ratio of 1:1:1:1. The randomization number lists will be generated by the random number generator of the SPSS software (Version 22.0; IBM Corp., NY, USA), the operator is the statistician of an independent third-party organization.

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：

（1） 参与者致盲：tACS研究中的核心挑战是创建一个可信的假条件，模拟真实刺激的瞬时物理感觉（例如，初始瘙痒、刺痛），而不提供假定具有生物活性的持续、特定相振荡电流。我们的假手术程序将使用相同的电极拼接和设备设置。假刺激将以短暂的低强度电流斜坡（例如10-30秒）开始，以复制初始皮肤感觉，随后在剩余的疗程中自动停止电流传递。这种“渐入/缓降”假手术方案被广泛采用，并已被证实能维持有效的致盲效果。（2）研究者致盲：负责应用电极、操作刺激器和进行主要结果评估的实验者将对分组不知情。刺激装置（主动/假手术）将由不参与任何数据收集的独立研究协调员预先编程和编码。在整个试验中，每个装置将被锁定到一个特定的随机代码（例如，“a”或“B”）。盲法实验者只需使用分配给参与者的编码设备按照相同的设置程序进行设置。

Blinding：

(1) Participant blinding: The core challenge in tACS studies is creating a credible sham condition that mimics the transient physical sensations of real stimulation (e.g., initial itching, tingling) without delivering the sustained, phase-specific oscillatory current presumed to be biologically active. Our sham procedure will utilize an identical electrode montage and device setup. The sham stimulation will initiate with a brief, low-intensity current ramp (e.g., 10-30 seconds) to replicate the initial cutaneous sensation, followed by an automatic cessation of current delivery for the remainder of the session. This "fade-in/ramp-down" sham protocol is widely adopted and has been validated to maintain effective blinding. (2) Investigator Blinding: The experimenters responsible for applying the electrodes, operating the stimulator, and conducting primary outcome assessments will be blinded to group allocation. The stimulation devices (active/sham) will be pre-programmed and coded by an independent study coordinator who will not participate in any data collection. Each device will be locked to a specific, randomized code (e.g., "A" or "B") for the entire trial. The blinded experimenter will simply follow an identical setup procedure using the coded device assigned to the participant.

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：

稳健的数据管理和系统监控是确保临床试验数据完整性、质量和可靠性的基础。我们将实施严格的协议，遵守美国铝业+数据管理和监控原则（可归因、清晰、同步、原始、准确，以及完整、一致、持久和可用）。将采用经验证的电子数据管理（EDM）系统进行数据收集和管理。在研究开始之前，我们将设计电子CRF，以便与方案的评估时间表和终点精确一致。EDC系统将配置预编程编辑检查，包括范围检查、逻辑一致性检查和交叉形式验证，以在现场人员输入数据期间实时识别潜在差异。正式的查询管理过程是我们工作流程的核心；系统标记的或审查期间发现的任何不一致都会触发对调查网站的电子查询，以进行澄清或更正。在完成所有数据输入、查询解析和最终质量控制审查之后，我们将执行正式的数据库锁定过程，然后将锁定的匿名分析数据集导出以进行统计分析。一个独立的数据和安全监测委员会将根据预先批准的章程运作，并定期召开会议，对积累的有效性和安全性数据进行非盲审查。将对监测计划中定义的关键疗效和安全性终点进行源数据验证，以确认CRF条目相对于原始源文件的准确性。如果出现严重的方案偏差或重大不良事件，将实施方案修订并提交机构审查委员会批准。

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

We will be implemented the rigorous protocol adheres to the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and also Complete, Consistent, Enduring, and Available) for data management and monitoring. The validated Electronic Data Management (EDM) system will be employed to data collection and management. Prior to study initiation, we will be designed electronic CRF to align precisely with the protocol's schedule of assessments and endpoints. The EDC system will be configured with pre-programmed edit checks, including range checks, logical consistency checks, and cross-form validations, to identify potential discrepancies in real-time during data entry by site personnel. A formal query management process was central to our workflow; any inconsistencies flagged by the system or identified during review triggered an electronic query to the investigative site for clarification or correction. Following the completion of all data entry, query resolution, and a final quality control review, we will be executed a formal database lock procedure, and the locked, anonymized analysis dataset was then will be exported for statistical analysis. An independent Data and Safety Monitoring Board will operate under a pre-approved charter and convene at regular intervals to perform unblinded reviews of accumulating efficacy and safety data. Source data verification for critical efficacy and safety endpoints—as defined in the monitoring plan—will be carried out to confirm the accuracy of CRF entries against original source documents. In the event of serious protocol deviations or major adverse events, a protocol amendment will be implemented and submitted for approval by the institutional review board.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-03-23 09:56:58