ChiCTR2500109932 版本V1.0 版本创建时间2025/09/26 17:50:51 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：

ChiCTR2500109932 

最近更新日期：

Date of Last Refreshed on：

2025-09-26 17:50:35 

注册时间：

Date of Registration：

2025-09-26 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

11·（审核员标记请勿删除；确认征募研究观察对象时间！！！如果参试者已经开始入组，请将首例参试者的知情同意书隐去姓名电话，保留签字日期，与知情同意书模板合并为同一个文件，一同上传，并同时确认征募研究对象情况是否结束招募；修改完，请回复邮件到chictr-s1@wchscu.cn；）基于环状RNA探讨重复经颅磁刺激对卒中患者上肢运动功能的疗效研究

Public title：

Study on the therapeutic effect of repetitive transcranial magnetic stimulation on upper limb motor function in stroke patients based on circular RNA

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于环状RNA探讨重复经颅磁刺激对卒中患者上肢运动功能的疗效研究

Scientific title：

Study on the therapeutic effect of repetitive transcranial magnetic stimulation on upper limb motor function in stroke patients based on circular RNA

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：

张秀慧 

研究负责人：

王培 

Applicant：

Xiuhui Zhang 

Study leader：

Pei Wang 

申请注册联系人电话：

Applicant telephone：

+86 178 6048 9018

研究负责人电话：

Study leader's telephone：

+86 159 5175 2352

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：

961911560@qq.com

研究负责人电子邮件：

Study leader's E-mail：

wangpei0717@126.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：

南京市鼓楼区新模范马路3号

研究负责人通讯地址：

南京市鼓楼区新模范马路3号

Applicant address：

3 New Model Road, Gulou District, Nanjing

Study leader's address：

3 New Model Road, Gulou District, Nanjing

申请注册联系人邮政编码：

Applicant postcode：

210003

研究负责人邮政编码：

Study leader's postcode：

210003

申请人所在单位：

东南大学附属中大医院

Applicant's institution：

Zhongda Hospital of Southeast University

研究负责人所在单位：

东南大学附属中大医院

Affiliation of the Leader：

Zhongda Hospital of Southeast University

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：

2025ZDSYLL187-P01

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：

东南大学附属中大医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of Zhongda Hospital, Southeast University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-05-30 00:00:00

伦理委员会联系人：

王慧萍

Contact Name of the ethic committee：

wang huiping

伦理委员会联系地址：

南京市鼓楼区丁家桥87号

Contact Address of the ethic committee：

No. 87, Dingjiaqiao, Gulou District, Nanjing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 25 8327 2015

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：

东南大学附属中大医院

Primary sponsor：

Zhongda Hospital of Southeast University

研究实施负责（组长）单位地址：

南京市鼓楼区新模范马路3号

Primary sponsor's address：

3 New Model Road, Gulou District, Nanjing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu province

City：

单位(医院)：

东南大学附属中大医院

具体地址：

南京市鼓楼区新模范马路3号

Institution
hospital：

Zhongda Hospital of Southeast University

Address：

3 New Model Road, Gulou District, Nanjing

经费或物资来源：

无

Source(s) of funding：

none

Target disease：

stroke

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：

本研究旨在鉴定和验证脑卒中患者中差异表达的circRNA，观察rTMS治疗前后环状RNA的表达变化，运用Fugl-Meyer评估量表、神经电生理、近红外／核磁共振等指标观察治疗前后的疗效，探索两者之间是否存在相关性，以确定环状RNA作为脑卒中患者rTMS治疗疗效的生物标志物的可行性，未来有望为个性化治疗提供新的思路。同时，基于神经电生理和脑活动相关神经影像学的指标，探讨circRNA在脑卒中的可能机制和评估其作为新治疗靶点的潜力。  

Objectives of Study：

The aim of this study is to identify and validate differentially expressed circRNAs in stroke patients, observe changes in the expression of circular RNAs before and after rTMS treatment, use Fugl Meyer evaluation scale, neurophysiology, near-infrared/nuclear magnetic resonance and other indicators to observe the efficacy before and after treatment, explore whether there is a correlation between the two, and determine the feasibility of circular RNAs as biomarkers for rTMS treatment efficacy in stroke patients. In the future, it is expected to provide new ideas for personalized treatment. Meanwhile, based on neuroelectrophysiological and neuroimaging indicators related to brain activity, explore the possible mechanisms of circRNA in stroke and evaluate its potential as a new therapeutic target.

药物成份或治疗方案详述：

无 

Description for medicine or protocol of treatment in detail：

none 

纳入标准：

诊断标准：符合第四届全国脑血管病会议中的卒中诊断标准，通过CT或MRI等辅助检查手段诊断为缺血性脑卒中。 纳入标准： 1.年龄25-80岁(含），男女不限，意识清楚，无严重认知障碍，能遵令完成相应评估； 2.首次单侧脑卒中，脑梗塞病程小于等于6个月（脑卒中恢复期患者）； 3.临床病情稳定，冠心病、高血压、糖尿病、高血脂等基础疾病控制良好； 4.上肢Brunnstrom偏瘫分期为II-IV期； 5.所有受试者知晓本试验细则，同意参与本试验，并签署知情同意书。 健康受试者纳入标准： 1.年龄25～80 周岁； 2.健康状况良好，无脑血管疾病、无颅脑及脊髓损伤、无神经肌肉疾病或损伤等症状； 3.同意参加本次试验并签署知情同意书。

Inclusion criteria

Diagnostic criteria: Meet the diagnostic criteria for stroke in the 4th National Conference on Cerebrovascular Diseases, and diagnose ischemic stroke by auxiliary examination methods such as CT or MRI. Inclusion Criteria: 1. Age 25-80 years old (inclusive), male or female, clear consciousness, no severe cognitive impairment, able to complete the corresponding assessment in accordance with orders; 2. First unilateral stroke, the duration of cerebral infarction is less than or equal to 6 months (patients in the recovery period of stroke); 3. Stable clinical condition, with good control of underlying diseases such as coronary heart disease, hypertension, diabetes, and hyperlipidemia; 4. The stage of Brunnstrom hemiplegia of the upper extremities is stage II-IV; 5. All subjects are aware of the rules of this trial, agree to participate in this trial, and sign the informed consent form. Inclusion Criteria for Healthy Subjects: 1. Age 25~80 years old; 2. Good health, no cerebrovascular disease, no cranial and spinal cord injury, no neuromuscular disease or injury and other symptoms; 3. Agree to participate in this trial and sign the informed consent form.

排除标准：

1.进展性卒中或出现继发性脑出血； 2.严重认知障碍或合并多器官功能障碍者； 3.其他疾病导致上肢功能异常者； 4.近一月内使用普通肝素或低分子肝素； 5.肿瘤病史和近三个月内手术史。

Exclusion criteria：

1. Progressive stroke or secondary cerebral hemorrhage; 2. Severe cognitive impairment or combined with multiple organ dysfunction; 3. Those who have abnormal upper limb function due to other diseases; 4. Use of unfractionated heparin or low molecular weight heparin in the past month; 5. History of tumor and surgery in the past three months.

研究实施时间：

Study execute time：

从 From 2025-04-01 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-06-03 00:00:00 至 To 2027-05-31 00:00:00  

干预措施：

Interventions：

组别：

健康对照组（HC组）

样本量：

31

Group：

Healthy control group

Sample size：

干预措施：

无

干预措施代码：

 1

Intervention：

none

Intervention code：

组别：

rTMS对照组

样本量：

31

Group：

rTMS control group

Sample size：

干预措施：

对照组接受常规的上肢康复治疗，每次治疗40min，根据脑卒中恢复期患者运动功能进行上肢康复训练，对于上肢运动功能较差、肌力较弱的患者，根据其特点在无痛或少痛范围内从近端关节至远端关节进行被动活动，通过Bobath握手，在健手的帮助下做伸肘、肩关节前屈运动等。目标是通过主动和被动训练，促进肌力恢复和主动活动出现，预防压疮、关节僵硬等并发症。对于上肢存在一定的运动功能、肌力尚可的患者，根据其特点针对偏瘫上肢加强伸肌肌力，抑制屈肌张力，加强运动控制和协调性训练。目标是加强协调性和选择性随意运动，强化日常生活活动训练，注意抑制异常的肌张力，重点是建立正常运动模式和恢复运动控制能力。同时，进行上肢综合运动训练、手功能训练等作业治疗； 同时，对照组接受rTMS假刺激。rTMS刺激使用的具体详细参数如下：刺激频率为10HZ，刺激强度为80%RMT，刺激间隔为10.0s，共刺激1200个脉冲。只是将线圈旋转90°，以上治疗1次/d，6次/周，持续治疗2周。

干预措施代码：

 2

Intervention：

The control group received routine upper limb rehabilitation treatment for 40 minutes each time. Upper limb rehabilitation training was carried out based on the motor function of stroke patients in the recovery period. For patients with poor upper limb motor function and weak muscle strength, passive activities were performed from the proximal joint to the distal joint within a painless or minimally painful range according to their characteristics. Bobath shook hands and with the help of a healthy hand, elbow extension and shoulder flexion exercises were performed. The goal is to promote muscle strength recovery and active activity through active and passive training, and prevent complications such as pressure ulcers and joint stiffness. For patients with certain motor function and decent muscle strength in the upper limbs, according to their characteristics, strengthen extensor muscle strength, inhibit flexor muscle tension, and enhance motor control and coordination training for hemiplegic upper limbs. The goal is to enhance coordination and selective voluntary exercise, strengthen daily life activity training, pay attention to suppressing abnormal muscle tone, and focus on establishing normal exercise patterns and restoring exercise control ability. At the same time, perform comprehensive upper limb exercise training, hand function training, and other occupational therapies; Meanwhile, the control group received rTMS sham stimulation. The specific detailed parameters used for rTMS stimulation are as follows: stimulation frequency of 10Hz, stimulation intensity of 80% RMT, stimulation interval of 10.0s, and a total of 1200 pulses stimulated. Just rotate the coil 90 ° and treat it once a day, 6 times a week, for 2 weeks.

Intervention code：

组别：

rTMS干预组

样本量：

31

Group：

rTMS intervention group

Sample size：

干预措施：

干预组接受常规的上肢康复治疗，每次治疗40min，根据脑卒中恢复期患者运动功能进行上肢康复训练，对于上肢运动功能较差、肌力较弱的患者，根据其特点在无痛或少痛范围内从近端关节至远端关节进行被动活动，通过Bobath握手，在健手的帮助下做伸肘、肩关节前屈运动等。目标是通过主动和被动训练，促进肌力恢复和主动活动出现，预防压疮、关节僵硬等并发症。对于上肢存在一定的运动功能、肌力尚可的患者，根据其特点针对偏瘫上肢加强伸肌肌力，抑制屈肌张力，加强运动控制和协调性训练。目标是加强协调性和选择性随意运动，强化日常生活活动训练，注意抑制异常的肌张力，重点是建立正常运动模式和恢复运动控制能力。同时，进行上肢综合运动训练、手功能训练等作业治疗； 同时，干预组接受rTMS真刺激。rTMS刺激使用的具体详细参数如下：刺激频率为10HZ，刺激强度为80%RMT，刺激间隔为10.0s，共刺激1200个脉冲。以上治疗1次/d，6次/周，持续治疗2周。

干预措施代码：

 3

Intervention：

The intervention group received routine upper limb rehabilitation treatment, with each treatment lasting 40 minutes. Upper limb rehabilitation training was carried out based on the motor function of stroke patients in the recovery period. For patients with poor upper limb motor function and weak muscle strength, passive activities were performed from the proximal joint to the distal joint within a painless or minimally painful range according to their characteristics. Bobath shook hands and with the help of a healthy hand, elbow extension and shoulder flexion exercises were performed. The goal is to promote muscle strength recovery and active activity through active and passive training, and prevent complications such as pressure ulcers and joint stiffness. For patients with certain motor function and decent muscle strength in the upper limbs, according to their characteristics, strengthen extensor muscle strength, inhibit flexor muscle tension, and enhance motor control and coordination training for hemiplegic upper limbs. The goal is to enhance coordination and selective voluntary exercise, strengthen daily life activity training, pay attention to suppressing abnormal muscle tone, and focus on establishing normal exercise patterns and restoring exercise control ability. At the same time, perform comprehensive upper limb exercise training, hand function training, and other occupational therapies; Meanwhile, the intervention group received rTMS true stimulation. The specific detailed parameters used for rTMS stimulation are as follows: stimulation frequency of 10Hz, stimulation intensity of 80% RMT, stimulation interval of 10.0s, and a total of 1200 pulses stimulated. The above treatment is given once a day, 6 times a week, and continues for 2 weeks.

Intervention code：

组别：

测序组

样本量：

12

Group：

Sequencing Group

Sample size：

干预措施：

无

干预措施代码：

 4

Intervention：

none

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China 

Province：

Jiangsu province 

City：

 

单位(医院)：

东南大学附属中大医院 

单位级别：

三甲医院 

Institution
hospital：

zhongda hospital of southeast university

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

上肢Fugl-Meyer运动功能评分

指标类型：

主要指标

Outcome：

Fugl-Meyer Assessment-Upper Extremities

Type：

Primary indicator

测量时间点：

干预之前与干预之后

测量方法：

量表测量

Measure time point of outcome：

Before and after intervention

Measure method：

Scale measurement

指标中文名：

改良Barthel指数

指标类型：

次要指标

Outcome：

Modified Barthel Index

Type：

Secondary indicator

测量时间点：

干预之前与干预之后

测量方法：

量表测量

Measure time point of outcome：

Before and after intervention

Measure method：

Scale measurement

指标中文名：

神经电生理指标,如静息运动阈值

指标类型：

次要指标

Outcome：

resting motor threshold

Type：

Secondary indicator

测量时间点：

干预之前与干预之后

测量方法：

机器测量

Measure time point of outcome：

Before and after intervention

Measure method：

machine measurement

指标中文名：

神经电生理指标，如运动诱发电位

指标类型：

次要指标

Outcome：

Motor Evoked Potential

Type：

Secondary indicator

测量时间点：

干预之前与干预之后

测量方法：

机器测量

Measure time point of outcome：

Before and after intervention

Measure method：

machine measurement

指标中文名：

功能性核磁共振

指标类型：

次要指标

Outcome：

functional MRI

Type：

Secondary indicator

测量时间点：

干预之前与干预之后

测量方法：

磁共振机器扫描

Measure time point of outcome：

Before and after intervention

Measure method：

Magnetic resonance machine scanning

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

标本中文名：

唾液

组织：

Sample Name：

saliva

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 25 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）：

在招募研究参与者之前，我们将建立一个随机化分组表，表中的编号将与实验参与者一一对应。符合标准的卒中患者将被（按1:1的基础）随机分配至对照组（n=31）或干预组（n=31）。随机分配的过程将由独立于研究团队的第三方实施，以确保随机性的可靠性。

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

Before recruiting research participants, we will establish a randomization table, where the numbers in the table will correspond one-to-one with the experimental participants. Stroke patients who meet the criteria will be randomly assigned (on a 1:1 basis) to either the control group (n=31) or the intervention group (n=31). The process of random allocation will be implemented by a third party independent of the research team to ensure the reliability of randomness.

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：

由于研究的干预性质，在实验中不可能对卒中患者的治疗师及参与者使用盲法，但该治疗师将不会参与评估环节。另外，参与评估与统计分析的研究人员将不参与参与者的筛选和分配。所有结果数据将由进行随机分组的人员(独立于研究小组)使用唯一编号和小组代码(第1组和第2组)收集和输入。

Blinding：

Due to the intervention nature of the study, it is not possible to use blinding on the therapist and participants of stroke patients in the experiment, but the therapist will not participate in the evaluation process. In addition, researchers involved in evaluation and statistical analysis will not participate in the screening and allocation of participants. All outcome data will be collected and inputted by personnel conducting random grouping (independent of the research group) using unique identification numbers and group codes (Group 1 and Group 2).

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

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）：

国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)，在试验结束六个月时间内上传

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

National Center for Bioinformation China National Center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/), uploaded within six months of the end of the trial

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：

数据采集与管理将结合病例记录表与电子采集和管理系统进行

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

Data collection and management will be combined with case record forms and electronic collection and management systems

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：

  2025-09-26 17:50:35