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重复经颅磁刺激结合电针治疗卒中后中枢神经痛的镇痛疗效及对丘脑-皮质功能连接网络的影响

注册号：

Registration number：

ITMCTR2025001042

最近更新日期：

Date of Last Refreshed on：

2025-05-26

注册时间：

Date of Registration：

2025-05-26

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

重复经颅磁刺激结合电针治疗卒中后中枢神经痛的镇痛疗效及对丘脑-皮质功能连接网络的影响

Public title：

Analgesic effect of repeated transcranial magnetic stimulation combined with electroacupuncture in the treatment of central neuralgia after stroke and its influence on the functional connection network of thalamic-cortex

注册题目简写：

English Acronym：

研究课题的正式科学名称：

重复经颅磁刺激结合电针治疗卒中后中枢神经痛的镇痛疗效及对丘脑-皮质功能连接网络的影响

Scientific title：

Analgesic effect of repeated transcranial magnetic stimulation combined with electroacupuncture in the treatment of central neuralgia after stroke and its influence on the functional connection network of thalamic-cortex

研究课题的正式科学名称简写：

Scientific title acronym：

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：

孙婷婷

研究负责人：

孙婷婷

Applicant：

suntingting

Study leader：

suntingting

申请注册联系人电话：

Applicant telephone：

18846925417

研究负责人电话：

Study leader's telephone：

18846925417

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：

stt1990action@163.com

研究负责人电子邮件：

Study leader's E-mail：

stt1990action@163.com

申请单位网址(自愿提供)：

Study leader's 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：

上海市松江区光星路2209号

研究负责人通讯地址：

上海市松江区光星路2209号

Applicant address：

2209 Guangxing Road Songjiang District Shanghai

Study leader's address：

2209 Guangxing Road Songjiang District Shanghai

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：

上海市养志康复医院（上海市阳光康复中心）

Applicant's institution：

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

养志伦审2024-065

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

上海市养志康复医院（上海市阳光康复中心）医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

伦理委员会批准日期：

Date of approved by ethic committee：

2024/8/13 0:00:00

伦理委员会联系人：

王笑凡

Contact Name of the ethic committee：

wangxiaofan

伦理委员会联系地址：

上海市松江区光星路2209号

Contact Address of the ethic committee：

2209 Guangxing Road Songjiang District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-37730011

伦理委员会联系人邮箱：

Contact email of the ethic committee：

stt1990action@163.com

研究实施负责（组长）单位：

上海市养志康复医院（上海市阳光康复中心）

Primary sponsor：

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

研究实施负责（组长）单位地址：

上海市松江区光星路2209号

Primary sponsor's address：

2209 Guangxing Road Songjiang District Shanghai

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

市(区县)：

Country：

China

Province：

Shanghai Municipality

City：

单位(医院)：

上海市养志康复医院（上海市阳光康复中心）

具体地址：

上海市松江区光星路2209号

Institution
hospital：

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

Address：

2209 Guangxing Road Songjiang District Shanghai

经费或物资来源：

上海市养志康复医院（上海市阳光康复中心）

Source(s) of funding：

2209 Guangxing Road Songjiang District Shanghai

研究疾病：

卒中后中枢神经痛

研究疾病代码：

Target disease：

Central neuralgia after stroke

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

运用现代医学理论及多学科交叉理论，选择一种先进的检测设备，运用了静息态功能磁共振成像（resting-state functional magnetic resonance imaging, re-fMRI）检测每种干预方法治疗前后丘脑-皮质功能连接变化，从临床试验角度研究的丘脑-皮质功能连接变化与CPSP之间的关系，为进一步探讨CPSP的脑网络连接与CPSP后感觉恢复的相关性，为患者探索新的康复模式。

Objectives of Study：

Using modern medical theory and interdisciplinary theory, selecting an advanced testing equipment,resting-state functional magnetic resonance imaging (re-fMRI) was used to detect the changes of thalamic-cortical functional connections before and after each intervention.The relationship between the changes of thalamic-cortical functional connectivity and CPSP was studied from the perspective of clinical trials, in order to further explore the correlation between brain network connectivity of CPSP and sensory recovery after CPSP, and to explore a new rehabilitation model for patients.

药物成份或治疗方案详述：

rTMS组：采用rTMS治疗仪，具体操作如下：嘱患者取仰卧位，全身放松，以患侧大脑皮层运动区（M1区）为刺激部位，治疗时 将“8”字型线圈中心置于患侧大脑皮层运动区（M1区），与患者头皮表面相切。刺激参数：频率为10 Hz，刺激时间10s，间歇时间5 s，刺激强度 80% ~ 100%MT，总刺激数1200个。每次20min，每周治疗5次为1个疗程，每个疗程间隔2d，共治疗4周。 夹脊穴电针组：根据患者感觉障碍区相应的神经节段，上肢疼痛患者选取颈夹脊，下肢疼痛者选取腰夹脊。采用直径为0.25mm×40mm的华佗牌毫针常规消毒后自上而下左右交替向棘突方向呈 45°斜刺，进针约0.5 ～ 1寸，得气后施平补平泻。每次20min，每周治疗5次为1个疗程，每个疗程间隔2d，共治疗4周。 rTMS联合夹脊穴电针组：rTMS和夹脊穴电针治疗同上。

Description for medicine or protocol of treatment in detail：

rTMS group: The rTMS therapeutic instrument was used. The specific operations were as follows: the patient was asked to lie supine and relax the whole body. The affected cerebral cortex motor area (M1 area) was used as the stimulation site. During treatment, the center of the "8" shaped coil was placed in the affected cerebral cortex motor area (M1 area), which was tangential to the scalp surface of the patient.Stimulation parameters: frequency was 10 Hz, stimulation time was 10s, intermittent time was 5 s, stimulation intensity was 80% ~ 100%MT, and the total number of stimuli was 1200.Each treatment was 20min, 5 times a week as a course, each course interval was 2d, a total of 4 weeks of treatment. Jiaji electroacupuncture group: According to the corresponding ganglion segment of the sensory disturbance area of the patient, the neck pinch spine of the upper limb pain patients was selected, and the waist pinch spine of the lower limb pain patients was selected.After routine disinfection, a Huatuo brand millineedle with a diameter of 0.25mm×40mm was used to make a 45° oblique stab alternately from left to right to the direction of the spinous process, and the needle was injected about 0.5 ~ 1 inch. After obtaining qi, leveling, supplementing and purging were applied.Each treatment was 20min, 5 times a week as a course, each course interval was 2d, a total of 4 weeks of treatment. rTMS combined with Jiaji point electroacupuncture group: rTMS and Jiaji point electroacupuncture treatment as above.

纳入标准：

①经CT或MR确诊的脑卒中；②CPSP诊断符合相关标准；③生命体征平稳；④视觉模拟评分法（visual analogue scale，VAS）评分≥3分；⑤患者或家属签署知情同意书

Inclusion criteria

① Stroke diagnosed by CT or MR;② The diagnosis of CPSP meets the relevant criteria;③ Stable vital signs;(4) visual analogue scale (VAS) score ≥3 points;⑤ Patients or family members sign informed consent

排除标准：

①合并严重的肝肾功能受损；②其他原因引起的疼痛；③有明显的精神障碍；④有tDCS治疗禁忌证；⑤伴有癫痫；⑥合并严重失语及认知功能障碍；⑦其他原因不能配合

Exclusion criteria：

① Combined with severe liver and kidney function impairment;② Pain caused by other causes;③ have obvious mental disorders;④ There are contraindications of tDCS treatment;⑤ accompanied by epilepsy;⑥ Combined with severe aphasia and cognitive dysfunction;⑦ Other reasons can not cooperate

研究实施时间：

Study execute time：

从From 2024-05-01

至To      2025-10-01

征募观察对象时间：

Recruiting time：

从From 2025-07-01

至To      2025-10-01

干预措施：

Interventions：

组别：

电针组

样本量：

24

Group：

Electroacupuncture group

Sample size：

干预措施：

根据患者感觉障碍区相应的神经节段，上肢疼痛患者选取颈夹脊，下肢疼痛者选取腰夹脊。

干预措施代码：

Intervention：

According to the corresponding ganglion segment of the sensory disturbance area of the patient, the cervical spine was selected for the upper limb pain patients, and the lumbar spine was selected for the lower limb pain patients.

Intervention code：

组别：

TMS结合电针组

样本量：

24

Group：

TMS combined with electroacupuncture group

Sample size：

干预措施：

rTMS治疗，以患侧大脑皮层运动区为刺激部位，将线圈中心置于患侧大脑皮层运动区，频率为10HZ；结合电针治疗：根据患者感觉障碍区相应的神经节段，上肢疼痛患者选取颈夹脊，下肢疼痛者选取腰夹脊。

干预措施代码：

Intervention：

rTMS treatment, the affected cerebral cortex motor area as the stimulation site, the frequency of 10HZ;Combined with electroacupuncture treatment: according to the corresponding ganglion segment of the patient's sensory disturbance area, the neck clip spine was selected for upper limb pain, and the waist clip spine was selected for lower limb pain.

Intervention code：

组别：

rTMS组

样本量：

24

Group：

TMS group

Sample size：

干预措施：

采用rTMS治疗仪，具体操作如下：嘱患者取仰卧位，全身放松，以患侧大脑皮层运动区（M1区）为刺激部位，治疗时 将“8”字型线圈中心置于患侧大脑皮层运动区（M1区），与患者头皮表面相切。刺激参数：频率为10 Hz，刺激时间10s，间歇时间5 s，刺激强度 80% ~ 100%MT，总刺激数1200个。每次20min，每周治疗5次为1个疗程，每个疗程间隔2d，共治疗4周。

干预措施代码：

Intervention：

rTMS was used to stimulate the motor area of the affected cerebral cortex (M1 area), and the center of the "8" shaped coil was placed in the motor area of the affected cerebral cortex (M1 area).Stimulation parameters: frequency was 10 Hz, stimulation time was 10s, intermittent time was 5 s, stimulation intensity was 80% ~ 100%MT, and the total number of stimuli was 1200.

Intervention code：

样本总量 Total sample size ： 72

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai Municipality

City：

单位(医院)：

上海市养志康复医院（上海市阳光康复中心）

单位级别：

三级康复专科医院

Institution/hospital：

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

Level of the institution：

Tertiary rehabilitation hospital

测量指标：

Outcomes：

指标中文名：

汉密尔顿焦虑量表

指标类型：

次要指标

Outcome：

Hamilton Anxiety Scale，HAMA

Type：

Secondary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

指标中文名：

丘脑-皮层功能连接

指标类型：

次要指标

Outcome：

Thalamic cortical functional connectivity

Type：

Secondary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

静息态功能磁共振

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Resting-state Functional Magnetic Resonance Imaging

指标中文名：

汉密尔顿抑郁量表

指标类型：

次要指标

Outcome：

Hamilton depression scale,HAMD

Type：

Secondary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

指标中文名：

视觉疼痛评估量表

指标类型：

主要指标

Outcome：

visual analogue scale

Type：

Primary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 15 岁
Min age years
最大 75 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

使用简单的分层(计算机生成)随机化协议。随机化是根据住院/门诊情况。主要研究人负责生成整个研究的分配顺序和分配，以及干预措施的分配。随机化发生在参与者的依从性检查之后。受试者将在研究期间由与试验无关的人员随机分组。

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

A simple hierarchical (computer generated) randomization protocol is used.Randomization was based on inpatient/outpatient situation.The principal investigator is responsible for generating the order and allocation of the entire study, as well as the allocation of interventions.Randomization occurred after participants' compliance checks.Subjects will be randomly assigned to individuals not associated with the trial during the study.

盲法：

双盲试验

Blinding：

double blind clinical trial

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）：

暂无

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

not available

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)电子数据采集的质量控制，在规定的时间窗口内采集数据，确保数据准确、真实、可靠和完整。2)对电子数据进行逻辑验证、源数据验证、数据汇总统计分析、质量检查和评价等原始控制措施，使临床研究达到要求的数据质量水平。临床试验结束后，需要仔细审查总结报告是否真实

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

1) Quality control of electronic data collection, data collection within the specified time window to ensure that the data is accurate, true, reliable and complete.2) Logical verification, source data verification, data summary statistical analysis, quality inspection and evaluation of electronic data and other original control measures are carried out to make clinical research reach the required data quality level.After the conclusion of the clinical trial, the summary report needs to be carefully reviewed for authenticity

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

暂无

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

not available

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