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间歇性Theta波爆发式刺激对脑卒中患者上肢运动功能的影响
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注册号：

Registration number：

 ChiCTR2500097636 

最近更新日期：

Date of Last Refreshed on：

 2025-02-23 19:00:01 

注册时间：

Date of Registration：

 2025-02-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

间歇性Theta波爆发式刺激对脑卒中患者上肢运动功能的影响

Public title：

Effects of Intermittent Theta Burst Stimulation on Upper Limb Motor Function in Stroke Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

间歇性Theta波爆发式刺激对脑卒中患者上肢运动功能的影响

Scientific title：

Effects of Intermittent Theta Burst Stimulation on Upper Limb Motor Function in Stroke Patients

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：

付艳鑫 

研究负责人：

武亮 

Applicant：

Yanxin Fu 

Study leader：

Liang Wu 

申请注册联系人电话：

Applicant telephone：

 +86 188 3437 2203

研究负责人电话：

Study leader's
telephone：

+86 152 1087 8101

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：

 fuyanxin0206@163.com

研究负责人电子邮件：

Study leader's E-mail：

 1972wuliang@sina.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：

北京市昌平区小汤山镇温泉街390号

研究负责人通讯地址：

北京市昌平区小汤山镇温泉街390号

Applicant address：

390 Wenquan Street, Xiaotangshan, Changping District, Beijing, China

Study leader's address：

390 Wenquan Street, Xiaotangshan, Changping District, Beijing, 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：

天津体育学院

Applicant's institution：

Tianjin University of Sport

研究负责人所在单位：

北京小汤山医院

Affiliation of the Leader：

Beijing Xiaotangshan Hospital

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：

 [2025]伦审第(01)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：

北京小汤山医院伦理审查委员会

Name of the ethic committee：

Beijing Xiaotangshan Hospital Ethics Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-21 00:00:00

伦理委员会联系人：

李佳航

Contact Name of the ethic committee：

Jiahang Li

伦理委员会联系地址：

北京市昌平区小汤山镇银街北路390号

Contact Address of the ethic committee：

390 Wenquan Street, Xiaotangshan, Changping District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 6178 9598

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：

北京小汤山医院

Primary sponsor：

Beijing Xiaotangshan Hospital

研究实施负责（组长）单位地址：

北京市昌平区小汤山镇温泉街390号

Primary sponsor's address：

390 Wenquan Street, Xiaotangshan, Changping District, Beijing, 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)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京小汤山医院

具体地址：

北京市昌平区小汤山镇温泉街390号

Institution
hospital：

Beijing Xiaotangshan Hospital

Address：

390 Wenquan Street, Xiaotangshan, Changping District, Beijing, China

经费或物资来源：

无

Source(s) of funding：

none

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：

（1）本研究采用间歇性Theta波爆发式刺激（intermittent theta burst stimulation，iTBS）和传统5Hz高频重复经颅磁刺激（high-frequency repetitive transcranial magnetic stimulation, HF-rTMS）对伴有上肢运动功能障碍的脑卒中患者进行干预，评估两种兴奋性经颅磁刺激模式对脑卒中患者上肢运动功能的影响。（2）明确两种模式的疗效差异，治疗效果从上肢运动功能恢复的临床表现及神经电生理层面进行评估，同时监测上肢感觉指标。（3）为有效改善卒中患者上肢运动功能的干预方法提供客观的试验依据。  

Objectives of Study：

(1) Intermittent Theta wave burst stimulation (iTBS) and traditional 5 Hz high frequency repetitive transcranial magnetic stimulation (HF-rTMS) were used to intervene stroke patients with upper limb motor dysfunction. To evaluate the effects of two excitatory transcranial magnetic stimulation modalities on upper extremity motor function in stroke patients. (2) To clarify the difference in curative effect between the two modes, and evaluate the treatment effect from the clinical signs of upper limb motor function recovery and neuroelectrophysiology, while monitoring the sensory indicators of the upper limb. (3) To provide an objective experimental basis for effective intervention methods to improve upper limb motor function in stroke patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

①头颅内金属异物者，带有植入式脉冲刺激发生器或药物泵者，有耳蜗植入者；②有高风险出现噪音性听力丧失的人（包括接受耳毒性药物治疗和接触溶剂的人）、有听觉过敏症状的患者；③妊娠期患者；④严重或近期心脏病者；⑤既往有癫痫史，有严重的心、肺、肝、肾等重要脏器功能衰竭者及有颅内高压症状者；⑥严重的认知、交流障碍、情绪障碍、烦躁等不能配合者；⑦参与本研究前3个月之内接受过iTBS或HF-rTMS治疗者；⑧有颅骨或手部存在缺陷等；⑨研究者认为不适合参与试验。

Exclusion criteria：

1 metallic foreign body in the head, with implantable pulse stimulation generator or drug pump, cochlear implant; 2 people at high risk of noise-induced hearing loss (including those treated with ototoxic drugs and those exposed to solvents), people with hyperacusis symptoms; 3 Pregnant patients; 4 severe or recent heart disease; 5 history of epilepsy, severe heart, lung, liver, kidney and other important organ failure, and intracranial hypertension; 6 severe cognitive, communication disorders, emotional disorders, irritability and other inability to cooperate; 7 those who received iTBS or HF-rTMS within 3 months before the study; 8 Skull or hand defects; 9 The investigator considered it inappropriate to participate in the trial.

研究实施时间：

Study execute time：

从 From 2025-01-12 00:00:00至 To 2026-01-12 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-24 00:00:00 至 To 2026-01-12 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 24

Group：

Experimental group

Sample size：

干预措施：

间歇性Theta波爆发式刺激联合常规康复治疗

干预措施代码：

Intervention：

Intermittent Theta burst stimulation combined with conventional rehabilitation therapy

Intervention code：

组别：

对照组

样本量：

 24

Group：

Control group

Sample size：

干预措施：

5Hz高频重复经颅磁刺激联合常规物理治疗

干预措施代码：

Intervention：

5Hz repetitive transcranial magnetic stimulation combined with conventional physical therapy

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)：

 北京小汤山医院 

单位级别：

 三级 

Institution
hospital：

Beijing Xiaotangshan Hospital

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer上肢运动功能评定量表

指标类型：

主要指标

Outcome：

Fugl-Meyer Assessment of Upper Extremity

Type：

Primary indicator

测量时间点：

试验开始前3天内，试验结束后3天内。

测量方法：

该量表包含33个评估项目，每项分别分为三个等级，0分：为不能进行或不能主动进行；1分：为微弱运动或部分可进行；2分：为能充分进行。此分值为累加总分，共66分，其得分越高，表明上肢运动功能恢复越好。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

The scale contains 33 assessment items, each of which is divided into three grades, 0: unable to perform or unable to perform actively; 1: weak movement or partially able to perform; 2: able to perform fully. This score is the cumulative total score, a total of 66 points, the higher the score, the better the recovery of upper limb motor function.

指标中文名：

上肢肌力及肌张力

指标类型：

主要指标

Outcome：

Upper limb muscle strength and tension

Type：

Primary indicator

测量时间点：

试验开始前3天内，试验结束后3天内。

测量方法：

本研究使用日本伊藤OE-210肌肉状况快速测定系统的肌力测定仪进行患侧上肢和手部肌肉力量的测量，使用日本伊藤OE-220肌肉状况快速测定系统的组织硬度仪进行患侧上肢和手部肌肉肌张力的测量。粗大运动肌肉力量及肌张力的测量主要包括肩前屈肌群和肘屈曲肌群，精细运动肌肉力量及肌张力的测量主要包括腕屈曲肌群和手抓握肌群。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

In this study, the muscle strength of the affected upper limb and hand was measured by the muscle dynamometer of the Japanese ITO OE-210 muscle status rapid measurement system, and the muscle tension of the affected upper limb and hand was measured by the tissue stiffness meter of the Japanese ITO OE-220 muscle status rapid measurement system. The measurement of gross motor muscle strength and tension mainly includes the shoulder forward flexor muscle group and elbow flexion muscle group, and th

指标中文名：

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：

试验开始前3天内，试验结束后3天内。

测量方法：

本研究采用VikingQues型号多导台式肌电/诱发电位仪（美国尼高力公司制造）和经颅磁刺激仪器（深圳英智公司制造）进行MEP测定。其中MEP潜伏期是从施加刺激开始到引起靶肌肉出现反映的时间；MEP波幅表示脑部电位活动的大小，是指从波峰到（幅度为零的）基线的垂直距离。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

In this study, MEP was measured by VikingQues multi-channel benchtop electromyography/evoked potential instrument (made by Nicolli Company, USA) and transcranial magnetic stimulation instrument (made by Shenzhen Yingzhi Company). The latency of MEP is the time from the stimulation to the response of the target muscle. MEP amplitude represents the magnitude of brain activity and is measured as the vertical distance from the peak to the baseline.

指标中文名：

中枢运动传导时间

指标类型：

次要指标

Outcome：

Central Motor Conduction Time

Type：

Secondary indicator

测量时间点：

试验开始前3天内，试验结束后3天内。

测量方法：

在运动诱发电位检测时，分别经大脑的运动皮质和神经根刺激，在相应肢体记录复合肌肉动作电位的潜伏期，二者潜伏期的差值称为中枢运动传导时间，可以反映中枢部分皮质脊髓束通路的功能状态，CMCT缩短表明脑卒中患者运动传导通路结构和功能的恢复。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

During motor evoked potential detection, the latency of compound muscle action potential was recorded in the corresponding limb after stimulation of the motor cortex and nerve root of the brain. The difference of the latency between the two is called the central motor conduction time, which can reflect the functional state of part of the central corticospinal tract pathway.

指标中文名：

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：

试验开始前3天内，试验结束后3天内。

测量方法：

RMT定义为在肌肉完全放松的状态下，在10次连续刺激中，至少有5次能激发出MEP且波幅超过50μV的刺激强度，用于评估脑卒中后大脑皮层的兴奋性。本研究采用VikingQues型多导台式肌电/诱发电位仪（美国尼高力公司生产） 和经颅磁刺激仪器（深圳市英智科技公司生产）检测健侧和患侧大脑的RMT。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

RMT was defined as the stimulation intensity that could stimulate MEP with amplitude exceeding 50 μV at least 5 times in 10 consecutive stimulations under the state of complete muscle relaxation, which was used to evaluate the excitability of cerebral cortex after stroke. In this study, the RMT of the healthy side and the affected side of the brain were detected by VikingQue multi-channel table EMG/evoked potential instrument (produced by Nicoli Company, USA) and transcranial magnetic stimulatio

指标中文名：

电流感觉阈值测定

指标类型：

次要指标

Outcome：

Current Perception Threshold

Type：

Secondary indicator

测量时间点：

试验开始前3天内，试验结束后3天内。

测量方法：

本研究使用美国纽罗特伦公司生产的Neurometer? CPT/C检测仪进行CPT，分别使用2000Hz、250Hz、5Hz三种不同频率的恒定电流电刺激患者患侧手部环指，2000Hz的电流主要刺激A-β纤维，250Hz主要刺激A-δ纤维，5Hz主要刺激C纤维，其中A-β纤维主要传导触觉和振动觉，A-δ纤维传导快痛和温度觉，C纤维传导慢痛和温度觉等。能引起感觉神经产生反应的最小电流强度就是感觉阈值，以此来研究两种兴奋性经颅磁刺激对不同神经纤维的阈值恢复的机制以及探索脑卒中后上肢感觉运动功能恢复机制。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

In this study, Neurometer ? CPT/C detector produced by American Neurometer Company was used for CPT, constant current with three different frequencies of 2000Hz, 250Hz and 5Hz was used to stimulate the ring finger of the affected hand of the patient, and 2000Hz current mainly stimulated A-β fibers. 250 Hz mainly stimulates A-δ fibers, and 5 Hz mainly stimulates C fibers, in which A-β fibers mainly conduct touch and vibration, A-δ fibers conduct fast pain and temperature, and C fibers conduct slo

指标中文名：

单丝感觉评分测试

指标类型：

次要指标

Outcome：

Semmes-Weinstein Monofilament

Type：

Secondary indicator

测量时间点：

试验开始前3天内，试验结束后3天内。

测量方法：

本研究采用20种不同直径和尺寸的单丝组件进行感觉功能测试，每种单丝在接触患者环指皮肤加力弯曲至90°时，产生不同大小的力量。单丝组件编号从1.65到6.65，数字越小，单丝越细，施加的压力阈值越低，说明患者的触觉越敏感。从较大数值（较粗单丝）的单丝开始测试，在测试点重复测试2-3次，每次测试之间要有适当的间隔时间（一般间隔3-5秒），以避免皮肤感受器的适应现象，保证测试结果的准确性。询问患者是否能感觉到单丝的刺激。如果患者能够感觉到刺激，就记录下此时单丝的编号。如果患者没有感觉到刺激，就换用更粗（数值更大）的单丝继续测试，直到患者能够感觉到刺激为止。最后，对测试结果进行记录。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

In this study, 20 monofilament components with different diameters and sizes were used to test sensory function. Each monofilament produced different forces when it was bent to 90 ° in contact with the skin of the patient's ring finger. The monofilament components are numbered from 1.65 to 6.65. The smaller the number, the thinner the monofilament, and the lower the threshold of applied pressure, indicating that the patient is more sensitive to touch. Start the test from the monofilament with la

指标中文名：

上肢动作研究量表

指标类型：

次要指标

Outcome：

Action Research Arm Test score

Type：

Secondary indicator

测量时间点：

试验开始前3天内，试验结束后3天内。

测量方法：

ARAT中的19项评估被分成4个子测试（抓、握、捏以及粗大运动）。每项为4级评分，0分：不能进行任何动作，或者完成时间超过60s；1分：能够完成部分测试内容，完成时间不超过60s；2分：能够完成，但完成困难或有时间延迟，包括存在异常的手部、上肢运动成分、身体姿势异常、用时超过5s但不超过60s；3分：能正常完成，各个动作正常，能在5秒内正常完成测试。一侧上肢最高分为57分，得分越高，表明上肢运动功能恢复越好。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

The 19 assessments in the ARAT were divided into 4 subtests (grasping, gripping, pinching, and gross motor). Each item is graded as Grade 4, 0: unable to perform any action, or the completion time is more than 60s; 1: able to complete part of the test content, the completion time is not more than 60s; 2: able to complete, but the completion is difficult or delayed, including the existence of abnormal hand, upper limb movement components, abnormal body posture, the time is more than 5S but not mo

指标中文名：

Wolf运动功能评价量表

指标类型：

主要指标

Outcome：

Wolf Motor Function Test

Type：

Primary indicator

测量时间点：

试验开始前3天内，试验结束后3天内。

测量方法：

WMFT通过对单关节运动、多关节运动和功能性活动计时以及对运动质量进行评估，可以定量评价患者上肢的运动能力。该量表由15个项目组成，其中6项为简单的关节运动，9项为复合的功能动作，对所有动作当场进行计时和动作质量打分，每项为6级评分，总分为75分，得分越高，表明上肢运动功能恢复越好。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

WMFT can quantitatively evaluate the motor ability of patients'upper limbs by timing single joint movement, multi-joint movement and functional movement and evaluating the quality of movement. The scale consists of 15 items, 6 of which are simple joint movements and 9 of which are complex functional movements. All movements are timed and scored on the spot. Each item is scored by 6 grades, with a total score of 75. The higher the score, the better the recovery of upper limb motor function.

指标中文名：

脑卒中影响量表-16

指标类型：

主要指标

Outcome：

Stroke Impact Scale -16

Type：

Primary indicator

测量时间点：

试验开始前3天内，试验结束后3天内。

测量方法：

SIS-16量表采用5级评分法，1分：完全做不到；2分：非常困难；3分：有些困难；4分：有点困难；5分：一点也不难。通过对16个项目得分的汇总和计算，最终可以计算出总得分，最高分为80分。总得分越高，表明患者的生活质量越高，功能状态越好。

Measure time point of outcome：

Within 3 days before the start of the experiment and within 3 days after the end of the experiment.

Measure method：

The SIS-16 scale uses a 5-point scale, 1: completely impossible, 2: very difficult, 3: somewhat difficult, 4: somewhat difficult, and 5: not difficult at all. By summarizing and calculating the scores of 16 items, the total score can be calculated, and the highest score is 80. The higher the total score, the higher the quality of life and the better the functional status of the patient.

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 30 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）：

实验不相干者；随机数字表

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

Experiment irrelevant;Random number table

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：

数据管理采用纸质+电子管理流程，制定电子版CRF表，每位受试者一份，并打印出来，存放于指定位置此表主要内容包括受试者基本信息、临床相关资料、知情同意书、随访记录、副作用量表等。测试的相关数据则录入指定电脑，采用电子化管理流程，进行严格的数据管理与质量控制。 当患者剔除、脱落后，研究者应尽可能与患者联系，完成所能完成的评估项目，并填写试验结束表，详细记录试验治疗记录。对因不良反应而脱落者，经随访最后判断与试验有关者，必须记录在CRF表并通知申办者。对任何脱落病例，研究者必须在CRF表中填写脱落的原因，一般情况下有6种：即不良事件、缺乏疗效、违背试验方案（包括依从性差者）、失访（包括患者自行退出）、被申办者中止和其他。

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

Each subject had one copy of the electronic CRF form, which was printed out and stored in the designated place. The main contents of the form included the basic information of the subjects, clinical related data, informed consent, follow-up records, side effects scale, etc. The relevant data of the test is entered into the designated computer, and the electronic management process is adopted to carry out strict data management and quality control. When a patient was excluded or dropped out, the investigator should contact the patient as much as possible to complete the evaluation items that could be completed, fill in the end of the trial form, and record the trial treatment record in detail. Dropouts due to adverse events should be recorded on the CRF form and notified to the sponsor. For any dropouts, investigators were required to fill in the CRF form the reasons for dropouts, which generally included six reasons: adverse events, lack of efficacy, protocol violations (including nonadherence), loss to follow-up (including withdrawal by the patient), discontinuation by the sponsor, and others.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-02-23 18:59:54
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