ChiCTR2000037798 版本V1.1 版本创建时间2020/11/02 06:54:58 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：

ChiCTR2000037798 

最近更新日期：

Date of Last Refreshed on：

2020-10-09 20:51:14 

注册时间：

Date of Registration：

2020-09-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

【辑】中枢联合外周重复经颅磁刺激 (rTMS) 对脑卒中后肢体功能和呼吸功能的影响

Public title：

The effects of central combined with peripheral repetitive transcranial magnetic stimulation (rTMS) on physical function and pulmonary function after stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中枢联合外周重复经颅磁刺激 (rTMS) 对脑卒中后肢体功能和呼吸功能的影响

Scientific title：

The effects of central combined with peripheral repetitive transcranial magnetic stimulation (rTMS) on physical function and pulmonary function after stroke

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：

张璇 

研究负责人：

蔡庆 

Applicant：

Xuan Zhang 

Study leader：

Qing Cai 

申请注册联系人电话：

Applicant telephone：

+86 13602452679

研究负责人电话：

Study leader's telephone：

+86 13636196032

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：

jadesysu2012@163.com

研究负责人电子邮件：

Study leader's E-mail：

ssjy0001@163.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：

广东省广州市天河区元岗路180号景晖苑

研究负责人通讯地址：

广东省广州市天河区天河路600号

Applicant address：

Jinghuiyuan, 180 Yuan'gang Road, Tianhe District, Guanghzhou, Guangdong, China

Study leader's address：

600 Tianhe Road, Tianhe District, Guangzhou, Guangdong, 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：

中山大学附属第三医院

Applicant's institution：

The Third Affiliated Hospital of Sun Yat sen University

研究负责人所在单位：

中山大学附属第三医院

Affiliation of the Leader：

The Third Affiliated Hospital of Sun Yat sen 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：

[2020]02-116-01

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：

中大附三医学伦理委员会

Name of the ethic committee：

The ethic committee of The Third Affiliated Hospital of Sun Yat sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2020-07-01 00:00:00

伦理委员会联系人：

黄凯琪

Contact Name of the ethic committee：

Qikai Huang

伦理委员会联系地址：

广东省广州市天河路600号

Contact Address of the ethic committee：

600 Tianhe Road, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20-85252131

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：

中山大学附属第三医院

Primary sponsor：

Third affiliated Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

广东省广州市天河区天河路600号

Primary sponsor's address：

600 Tianhe Road, Guangzhou, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

研究者自发

Source(s) of funding：

No extra funding

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

通过将外周联合中枢重复经颅磁刺激方案疗效与以往传统的单纯中枢重复经颅磁刺激方案进行疗效对比，探讨中枢联合外周重复经颅磁刺激对中风后呼吸功能及肢体功能的影响。  

Objectives of Study：

To examine the effect of cetral combined with peripheral repetitive transcranial magnetic stimulation in post-stroke physical function and pulmonary function.

药物成份或治疗方案详述：

两组患者均予常规药物治疗及康复训练，包括肌力、步行和步态训练、本体感觉神经肌肉促进技术、协调功能训练、平衡控制训练、运动再学习技术、日常生活活动能力训练，且康复治疗训练时间相同，每次30 min。 实验组在此基础上予外周联合中枢的 rTMS治疗，1 次/天，15 min/次，5 次/周，共治疗 4 周；对照组予以仅传统患侧rTMS治疗，1 次/天，15 min/次，5 次/周，共治疗 4 周。 具体刺激方案如下： （1）试验组：首先，外周远端刺激:①预刺激（处方1刺激频率：5Hz；每串脉冲数：20个；串数：15个；串间隔时间：2s；刺激强度：通过单刺激确定运动阈值（MT），采用105 % MT。另外，测定运动阈值时，将记录电极和参考电极分别贴置于患者健侧胫骨前肌肌腹表面皮肤、胫骨前肌肌腱上，地线置于同侧膝关节处，将磁刺激线圈轻置于患者下肢大脑皮质功能区(Cz稍往前2cm处左右)进行单脉冲刺激，观察运动诱发电位同时调节刺激强度，将10次刺激中至少有5次诱发的电位波幅大于50μV时的最小刺激强度定为静息运动阈值），用圆形线圈刺激患侧下肢神经主干和神经分支，即大腿沿着股神经、坐骨神经，小腿从腓总神经出口开始沿着腓深神经、腓浅神经、胫神经从近端至远端滑动刺激，每条神经各刺激3串，线圈移动大约需要2s。基本的原理是刺激神经引起相应的肌肉收缩；②高能量深层肌肉刺激（HDMS）作用于患侧下肢肌肉和肌腱结构进行放松，即治疗头将沿着下肢的肌筋膜单元依次进行放松，治疗时间大约3 min。③rTMS治疗阶段（处方2刺激频率：15Hz；每串脉冲数：20个；串数：15个；串间隔时间：2s；刺激强度：105% MT），重复上述步骤。其次，外周近端刺激: ①预刺激（处方1刺激频率：5Hz；每串脉冲数：20个；串数：16个；串间隔时间：2s；刺激强度：通过单刺激确定，以引起相应肌肉中等强度的收缩），用圆形线圈对患者腰椎区和骶区进行串刺激，刺激腰椎区时，线圈沿着肌肉链滑动（从T12到L5）分别刺激两侧竖脊肌和躯干肌收缩，且产生中等强度的收腹，两侧各4串刺激；刺激骶区时，以引起臀部的肌肉收缩和腿部肌肉有活动为宜，两侧各4串刺激，线圈移动大约需要2s。②HDMS作用于患者双侧腰部、骨盆向后运动的肌筋膜单元进行放松，治疗头主要作用于竖脊肌、髂腰韧带和腰方肌，治疗时间大约3 min。③rTMS治疗阶段（处方2刺激频率：15 Hz；每串脉冲数：20个；串数：16个；串间隔时间：2 s；刺激强度：105% MT），选择位于腰部和臀部的两侧的躯干后向和外向运动的肌筋膜单元协调中心（CC点），即第一腰椎水平的竖脊肌肌群上方、髂腰韧带至腰方肌起点上方、腰方肌上以及臀部肌肉（位于第4骶孔水平的臀中肌和臀大肌上），共计8个点，固定到每一个点进行刺激（没有移动），每个点刺激2串。最后，进行中枢皮层治疗区域刺激：①预刺激（处方3刺激频率：77Hz，每串脉冲数：140个；串数：12个；串间隔时间：2s；刺激强度：强度依患者的耐受而定，从10%逐步提高，直到患者感到不适时，再将此时的刺激强度下调2%），将线圈放在发际，从前额到枕骨纵向拉动线圈，5条纵向线拉动将重复2次。结束时从右耳到左耳在交叉拉动一次；②rTMS治疗刺激：在皮层运动和感觉区进行爆发刺激，每个部位刺激大约2-4次，采用处方4(刺激频率：77Hz,每串脉冲数：7个;串数：20个;串间隔时间：6s;刺激强度：通过单刺激确定运动阈值（MT），采用100 % MT。针对上肢和呼吸功能的刺激方案类似，将相应刺激点换成上肢靶肌肉和呼吸肌即可。 （2）对照组：即中枢刺激组，用8字线圈进行患侧中枢rTMS刺激，刺激参数为（刺激频率：10Hz；每串脉冲数：20个；串数：50个；串间隔时间：2s；刺激强度：通过单刺激确定MEP，用100%MT），刺激患侧运动皮质区即M1区或头顶中心区域，治疗时线圈于头皮相切，每次15分钟。 

Description for medicine or protocol of treatment in detail：

The participants in both groups will receive routine physical therapy, including muscle strength training, gait training, Proprioceptive Neuromuscular Facilitation, coordinate training, balance training, motor relearning programme and activities of daily living. The time of rutine physical therapy is euqal in both groups, i.e. 30 minutes every session. Except for the routine training, participants in the experimental group will also receive central combined with peripheral rTMS, 15 minutes every time, once every day, five days every week for four weeks while participants in the control group receive traditional rTMS on the affected side,15 minutes every time,once every day, five days every week for four weeks. The participants in both groups will receive routine physical therapy, including muscle strength training, gait training, Proprioceptive Neuromuscular Facilitation, coordinate training, balance training, motor relearning programme and activities of daily living. The time of routine physical therapy is equal in both groups, i.e. 30 minutes every session. Except for the routine training, participants in the experimental group will receive central combined with peripheral rTMS, 15 minutes every time, once every day, five days every week for four weeks while participants in the control group will receive traditional rTMS on the affected side, 15 minutes every time, once every day, five days every week for four weeks. There are three phases of the rTMS in the experimental group: the peripheral distal stimulation, the peripheral proximal stimulation and the central cortex stimulation. The peripheral distal stimulation starts with the prestimulation, whose parameters’ setting is named as stimulation one. The details of stimulation one are as follows: 5Hz, 20 stimulations every trial, 15 trials one session, two seconds interval between two consecutive trials, 105% resting motor threshold (MT). The test of MT uses the standard procedure, i.e. the recording electrode is on participants’ unaffected tibialis anterior muscle’s belly and the reference electrode is on the same tibialis anterior muscle’s tendon. The ground electrode is placed on the ipsilateral knee bone (the patella). Then put the coil on the cranium, and find the cortex which control lower limb function (approximately two centimeters in front of Cz point). After this, use different intensity of single-pulse stimulation to decide the MT, which is the minimal intensity that causes at least 5 action potentials whose potential amplitude are higher than 50μV out of 10 consecutive stimulation. Testing the MT of participants is the first step of rTMS. At this step, the stimulation one uses the circular coil to stimulate the affected lower limb’s main nerve trunks and branches, i.e. the coil moves from the femoral nerve/sciatic nerve to the tibial nerve/common peroneal nerve, and to the deep peroneal nerve and superficial peroneal nerve. Every nerve is stimulated by 3 trials, and in each trail, the coil moves from the proximal part to the distal part of the nerve, which costs two seconds. The principle is to stimulate the nerve to cause muscle contraction. Then is the high energy deep muscle stimulation (HDMS). It is used to relax the muscles and tendons of the lower limb. The HDMS’s probe moves from one muscle and fascia unit to another, and this needs three minutes. The final step of the peripheral proximal stimulation is the therapeutic stimulation (named stimulation 2): 15Hz, 20 stimulations every trial, 15 trials one session, two seconds interval between two consecutive trials, 105% (MT). The coil’s moving path and method are the same with the prestimulation. Likewise, the first step of proximal peripheral simulation is prestimulation. Except for the intensity and number of trails, the other parameters are the same with stimulation one. There are 16 trials in one session and the intensity is decided as the value which causes moderate contraction of the targeted muscles. The target muscles are the muscles in the lumbar and sacral regions. The circular coil slides with the muscle chain (T12 to L5), i.e. bilateral erector spinae and other trunk muscles. Moderate contraction of the abdominal muscles is required as well. Both the left and right side of trunk muscles receive 4 trails’ stimulation. When stimulate the sacral region, the principle is the same, i.e. to cause gluteal and leg muscles’ contraction. Every side will receive 4 trails. Then is the HDMS: the probe moves to relax bilateral lumbar and pelvic muscles and fascias. Afterwards, conduct the therapeutic stimulation, whose parameters are the same with stimulation 2’s except it has 16 trials instead of 15. Choose the lateral and extrovert myofascial unit coordination center (CC point) of the lumbar and gluteal regions, i.e. the erecor spinae at the level of L1, above the origin of quadrates lumborum, above the quadrates lumborum and the gluteal muscles (the gluteal medius and gluteal maximus at the level of the fourth sacral hole). There are eight points in total, with four in each side. The coil is put on every point (no movement), and every point will receive 2 trials. Finally, the central cortex stimulation comprises two steps. Step one is prestimulation, which is called stimulation three: 77Hz, 140 stimulations every trial, 12 trials one session, two seconds interval between two consecutive trials, the intensity is decided by the participants’ tolerance. The method to find participants’ tolerance is as follow: The initial intensity is 10%MT, and increasingly enhances the intensity until the participants feel uncomfortable. The intensity at the comfortable point minus 2%MT is the stimulation intensity. Put the coil on the hair line, and longitudinally moves the coil from the forehead to the occipital bone. There are five longitudinal lines, and the coil moves twice on every line. Afterwards, the coil moves from the left ear to the right ear and comes back. The second step is therapeutic stimulation: 77Hz, 7 stimulations every trial, 20 trials one session, six seconds interval between two consecutive trials and 100% MT. Put the coil on the sensory and motor cortex region to produce burst stimulation and every position receives 2 to 4 stimulations. The stimulation programmes of the upper limb function and pulmonary function is similar. The difference is that the stimulation area of the peripheral stimulations is the targeted upper limb nerves and muscles and respiratory nerves and muscles, instead of the nerves and muscle in the lower limb. 

纳入标准：

①年龄20-70岁；
②符合全国第四届脑血管病学术会议修订的《各类脑血管病的诊断要点1996年》诊断标准的脑血管病患者，均经头颅CT或MRI扫面证实；
③初发或复发脑出血或脑梗死患者；
④生命体征稳定，能配合完成治疗及测评；
⑤有肢体功能障碍，偏瘫侧下肢肌力≥3级；
⑥无行MRI、TMS检查的禁忌症；
⑦无严重认知功能障碍，MMSE（Minimun Mental State Examination）≥10分；
⑧无肺大泡、肺气肿、气胸等其他基础肺疾患的患者；
⑨入选患者均同意作为被试对象并签署知情同意书。

Inclusion criteria

1. Patients aged 20-70 years;
2. The patients with cerebrovascular diseases who met the diagnostic criteria of "diagnostic points of various cerebrovascular diseases, 1996" revised by the Fourth National Academic Conference on cerebrovascular diseases, were confirmed by CT or MRI scan;
3. Patients with initial or recurrent cerebral hemorrhage or cerebral infarction;
4. Patients with stable vital signs who can cooperate with the completion of treatment and evaluation;
5. Patients with limb dysfunction and lower limb muscle strength ≥ 3 on the hemiplegic side;
6. Patients without contraindications of MRI and TMS;
7. MMSE (minimum mental state examination) ≥ 10 points in patients without severe cognitive impairment;
8. Patients without pulmonary bullae, emphysema, pneumothorax and other basic lung diseases;
9. All the patients agreed to be the subjects and signed the informed consent.

排除标准：

①头颅内置有金属异物、带心脏起搏器者、心脏支架者、有耳蜗植入物者；
② 严重心、肺、肝、肾功能不全等并发症，恶性肿瘤；
③严重认知、语言功能障碍；
④既往有颅脑外伤、脑炎及其他颅内疾病等；
⑤伴有严重影响肢体感觉、运动的疾病，如风湿性关节炎、腰椎间盘突出症、上肢外伤和其他周围神经病者；
⑥既往有癫痫或精神异常者；
⑦颅内压增高的患者；
⑧近4周大咯血及有主动脉瘤患者。

Exclusion criteria：

1. Patients with metal foreign body, pacemaker, cardiac stent and cochlear implant in the head;
2. Patients with severe heart, lung, liver, kidney dysfunction and other complications, malignant tumor;
3. Patients with severe cognitive and language dysfunction;
4. Patients with previous craniocerebral trauma, encephalitis and other intracranial diseases;
5. Patients with diseases that seriously affect the feeling and movement of limbs, such as rheumatoid arthritis, lumbar disc herniation, upper limb trauma and other peripheral neuropathy;
6. Patients with epilepsy or mental disorders in the past;
7. Patients with increased intracranial pressure;
8. Patients with massive hemoptysis and aortic aneurysm in recent 4 weeks.

研究实施时间：

Study execute time：

从 From 2020-09-15 00:00:00至 To 2021-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2020-10-01 00:00:00 至 To 2021-02-15 00:00:00  

干预措施：

Interventions：

组别：

实验组

样本量：

10

Group：

Experimental Group

Sample size：

干预措施：

外周联合中枢经颅磁刺激

干预措施代码：

Intervention：

central combined peipheral rTMS

Intervention code：

组别：

对照组

样本量：

10

Group：

Control Group

Sample size：

干预措施：

传统中枢经颅磁刺激

干预措施代码：

Intervention：

traditional central rTMS

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China 

Province：

Guangdong 

City：

Guangzhou 

单位(医院)：

中山大学附属第三医院 

单位级别：

三甲医院 

Institution
hospital：

Third Affiliated Hospital of Sun Yat-Sen University

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

用力肺活量

指标类型：

主要指标

Outcome：

Forced vital capacity

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

心肺运动试验器械

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

Cardiopulmonary exercise test apparatus

指标中文名：

一秒用力呼气容积

指标类型：

主要指标

Outcome：

FEV1

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

心肺运动试验器械

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

Cardiopulmonary exercise test apparatus

指标中文名：

一秒用力呼吸容积百分比

指标类型：

主要指标

Outcome：

FEV1/FVC

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

心肺运动试验器械

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

Cardiopulmonary exercise test apparatus

指标中文名：

最高呼气流速

指标类型：

主要指标

Outcome：

maximum expiratory velocity

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

心肺运动试验器械

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

Cardiopulmonary exercise test apparatus

指标中文名：

最大呼气中段流量

指标类型：

主要指标

Outcome：

maximum midexpiratory flow

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

心肺运动试验器械

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

Cardiopulmonary exercise test apparatus

指标中文名：

最大通气量

指标类型：

主要指标

Outcome：

maximal ventilatory volume

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

心肺运动试验器械

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

Cardiopulmonary exercise test apparatus

指标中文名：

上肢表面肌电的反射肌电阈值

指标类型：

主要指标

Outcome：

upper limb reflex myoelectric threshold

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

surface myoelectricity

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

表面肌电

指标中文名：

上肢肌电均方根值

指标类型：

主要指标

Outcome：

upper limb root-mean-square，RMS

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

surface myoelectricity

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

表面肌电

指标中文名：

上肢肌分肌电值

指标类型：

主要指标

Outcome：

upper limb iEMG

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

surface myoelectricity

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

表面肌电

指标中文名：

3 米往返测试

指标类型：

主要指标

Outcome：

timed up and go test

Type：

Primary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

功能评估

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

functional test

指标中文名：

呼吸肌表面肌电

指标类型：

次要指标

Outcome：

respiratory muscle surface myoelectricity

Type：

Secondary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

surface myoelectricity

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

表面肌电

指标中文名：

膈肌运动速度

指标类型：

次要指标

Outcome：

diaphragm movement velocity

Type：

Secondary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

膈肌超声

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

diaphragm ultrasound

指标中文名：

肢体肌张力

指标类型：

次要指标

Outcome：

muscle tone of limb muscles

Type：

Secondary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

改良Ashworth 量表

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

modified Ashworth scale

指标中文名：

肢体运动功能

指标类型：

次要指标

Outcome：

physical function of limbs

Type：

Secondary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

Fugl-Meyer 量表

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

Fugl-Meyer Assessment

指标中文名：

步行速度

指标类型：

次要指标

Outcome：

walking speed

Type：

Secondary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

10 米步行速度测试

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

10 meters walking test

指标中文名：

日常生活活动能力

指标类型：

次要指标

Outcome：

activities of daily living

Type：

Secondary indicator

测量时间点：

试验前，1周后，2周后，4周后

测量方法：

改良bathel指数

Measure time point of outcome：

baseline, one week, two weeks and four weeks after intervention

Measure method：

modified bathel index

采集人体标本：

Collecting sample(s)
from participants：

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 20 岁 years
最大 Max age 70 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）：

由治疗师1将符合入组条件的患者，采用随机数字表法分为实验组和对照组，每组患者20例。

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

Therapist one will use random number table to divide the enrolled participants into two groups: the experimental group and the control group.

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：

采用双盲，实施干预和进行功能评估的治疗师均不知道患者的分组情况。

Blinding：

Double blind: therapists who apply the treatment and assessment are not aware of the group allocation.

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

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）：

在ResMan平台

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

ResMan

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：

用病例记录表采集数据，用Excel 表格进行数据管理。

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

The case report form is used to collect data and the management of data is via Excel table.

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：

  2020-09-02 02:53:27