ChiCTR2400082886 版本V1.0 版本创建时间2024/04/10 11:23:21 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：

ChiCTR2400082886 

最近更新日期：

Date of Last Refreshed on：

2024-04-10 11:23:17 

注册时间：

Date of Registration：

2024-04-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

重复经颅磁刺激联合磁刺激气海、关元、中极对脑卒中后神经源性膀胱的疗效分析

Public title：

Effect analysis of repeated transcranial magnetic stimulation combined with magnetic stimulation of Qi Hai, Guan Yuan and Zhong Ji for neurogenic bladder after stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

重复经颅磁刺激联合磁刺激气海、关元、中极对脑卒中后神经源性膀胱的疗效分析

Scientific title：

Effect analysis of repeated transcranial magnetic stimulation combined with magnetic stimulation of Qi Hai, Guan Yuan and Zhong Ji for neurogenic bladder 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：

张有为 

研究负责人：

尹昱 

Applicant：

Youwei Zhang 

Study leader：

Yu Yin 

申请注册联系人电话：

Applicant telephone：

+86 187 3039 9098

研究负责人电话：

Study leader's telephone：

+86 177 9809 3116

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：

53604566@qq.com

研究负责人电子邮件：

Study leader's E-mail：

yinyu-99@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：

河北省石家庄市和平西路348号

研究负责人通讯地址：

河北省石家庄市和平西路348号

Applicant address：

348 Heping West Road, Shijiazhuang, Hebei

Study leader's address：

348 Heping West Road, Shijiazhuang, Hebei

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：

河北省人民医院

Applicant's institution：

Hebei Provincial People's Hospital

研究负责人所在单位：

河北省人民医院

Affiliation of the Leader：

Hebei Provincial People's Hospital

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：

(2024)科研伦审第(083)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：

河北省人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Hebei Provincial People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-03-19 00:00:00

伦理委员会联系人：

鲁杨

Contact Name of the ethic committee：

Yang Lu

伦理委员会联系地址：

河北省石家庄市和平西路348号

Contact Address of the ethic committee：

348 Heping West Road, Shijiazhuang, Hebei

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 311 8598 8311

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：

河北省人民医院

Primary sponsor：

Hebei Provincial People's Hospital

研究实施负责（组长）单位地址：

河北省石家庄市和平西路348号

Primary sponsor's address：

348 Heping West Road, Shijiazhuang, Hebei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河北

市(区县)：

石家庄

Country：

China

Province：

Hebei

City：

Shijiazhuang

单位(医院)：

河北省人民医院

具体地址：

和平西路348号

Institution
hospital：

Hebei Provincial People's Hospital

Address：

348 Heping West Road

经费或物资来源：

研究生课题经费

Source(s) of funding：

Postgraduate project funding

Target disease：

Neurogenic bladder after stroke

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

为探索磁刺激穴位对脑卒中后神经源性膀胱的疗效。  

Objectives of Study：

To explore the effect of magnetic stimulation on neurogenic bladder after stroke.

药物成份或治疗方案详述：

常规康复治疗：间歇导尿、行为技巧训练、代偿性排尿训练（Valsalva屏气法）、常规膀胱护理、制定饮水计划。 重复经颅磁刺激：刺激模式为临床常用安全参数，刺激频率10Hz，刺激强度为90%静息运动阈值，刺激时间37分钟/次，1/日，5天/周，共治疗3周。 磁刺激气海、中极、关元：刺激模式为临床常用安全参数，刺激频率15Hz，刺激强度为50%静息运动阈值，刺激时间20分钟/次，1/日，5天/周，共治疗3周。 普通针刺气海、关元、中级：刺激时间20分钟/次，1/日，5天/周，共治疗3周。 实验组：实施常规康复治疗+重复经颅磁刺激+磁刺激关元、中极、气海。 对照组：实施常规康复治疗+重复经颅磁刺激+普通针刺关元、中极、气海。 

Description for medicine or protocol of treatment in detail：

Routine rehabilitation: intermittent catheterization, behavioral skills training, compensatory urination training (Valsalva breath-holding method), routine bladder care, water schedule. Repetitive transcranial magnetic stimulation: The stimulation mode was a common clinical safety parameter, the stimulation frequency was 10Hz, the stimulation intensity was 90% of the resting movement threshold, each stimulation was 37 minutes, once a day, five days a week, a total of 3 weeks of treatment. Magnetic stimulation Qi Hai, Zhong Ji and Guan Yuan: the stimulation mode is a common clinical safety parameter, the stimulation frequency is 15Hz, the stimulation intensity is 50% of the resting movement threshold, each stimulation is 20 minutes, once a day, five days a week, a total of 3 weeks of treatment. Ordinary acupuncture Qi Hai, Guan Yuan, Zhong Ji : each stimulation for 20 minutes, once a day, five days a week treatment, a total of 3 weeks. Experimental group: conventional rehabilitation therapy + repeated transcranial magnetic stimulation + magnetic stimulation Guan Yuan, Zhong Ji , Qi Hai. Control group: Routine rehabilitation treatment + repeated transcranial magnetic stimulation + ordinary acupuncture Guan Yuan, Zhong Ji, Qi Hai. 

纳入标准：

1.存在脑卒中病史（六个月内）且经CT或MRI证实；2.年龄30-75岁；3.存在下尿路症状：①储尿期：尿频、尿急、夜尿、尿失禁、遗尿、膀胱区疼痛不适等；②排尿期：尿等待、排尿困难、膀胱排空不全、尿潴留、尿痛；③排尿后症状：尿后滴沥等；4.尿常规检查正常；5.并已拔除留置导尿管；6.经尿流动力学或影像学检查诊断符合痉挛性神经源性膀胱的患者；7.患者入组前未进行相关磁刺激治疗；8.自愿加入本研究，患者及家属知情并签署知情同意书。

Inclusion criteria

1. History of stroke (within six month) confirmed by CT or MRI; 2. Age 30-75 years old; 3. There are lower urinary tract symptoms: ①Urinary storage period: frequent urination, urgent urination, night urination, incontinence, enuresis, pain and discomfort in the bladder area; ②Urination stage: urine waiting, dysuria, bladder insufficiency, urine retention, urinalgia; ③Symptoms after urination: dripping after urination; 4. Urine routine examination is normal; 5. The indwelling catheter has been removed; 6. Patients with spastic neurogenic bladder diagnosed by urodynamics or imaging; 7. The patients did not receive relevant magnetic stimulation therapy before enrollment; 8. Patients and their family members were informed and signed informed consent to join the study voluntarily.

排除标准：

1.意识障碍、认知障碍、头颅严重损伤患者；2.经检查证实有脑肿瘤、脑外伤、脑寄生虫及其他疾病，如心脏病合并房颤引起脑梗死者；3.颅内有金属，以脐下5寸为中心直径20cm内有金属固定物者；4.心脏起搏器植入者；5.合并糖尿病、肿瘤患者；6.尿路感染或其他严重感染患者；7.不符合间歇导尿条件患者；8.其他因素导致NB患者；9.严重肾积水、肾结石等肾脏疾病患者；10.利尿剂、脱水剂服用史者；11.合并有严重心脑血管、肝脏、肾脏等器官性疾病或有血液系统、循环系统障碍者；12.膀胱造瘘术或尿道前括约肌切开术史者；13.脑卒中前即存在排尿障碍或前列腺疾病、泌尿道畸形等患者；14.刺激点周围皮肤破溃感染；15.精神疾病患者；16.治疗依从性差，无法遵从医嘱的患者。

Exclusion criteria：

1. Patients with consciousness disorder, cognitive impairment, and severe head injury; 2. Confirmed brain tumors, brain trauma, brain parasites and other diseases, such as heart disease combined with atrial fibrillation caused by cerebral infarction; 3. There is metal in the skull, and there is metal fixation in the center of 5 inches below the umbilicus with a diameter of 20cm; 4. Cardiac pacemaker implants; 5. Patients with diabetes and tumor; 6. Patients with urinary tract infection or other serious infections; 7. Patients who do not meet the conditions for intermittent catheterization; 8. Other factors lead to NB patients; 9. Patients with kidney diseases such as severe hydronephrosis and kidney stones; 10. History of taking diuretics and dehydrating agents; 11. Patients with severe cardiovascular, cerebrovascular, liver, kidney and other organ diseases or with blood system and circulatory system disorders; 12. History of vesicostomy or anterior urethral sphincterotomy; 13. Patients with urinary disorders, prostate diseases and urinary tract malformations before stroke; 14. Skin rupture infection around the irritation point; 15. Persons with mental illness; 16. Patients with poor treatment compliance and unable to follow medical instructions.

研究实施时间：

Study execute time：

从 From 2024-03-28 00:00:00至 To 2025-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-04-15 00:00:00 至 To 2025-04-01 00:00:00  

干预措施：

Interventions：

组别：

实验组

样本量：

30

Group：

Experimental group

Sample size：

干预措施：

常规康复治疗+重复经颅磁刺激+磁刺激关元、中极、气海

干预措施代码：

Intervention：

Conventional rehabilitation treatment + repeated transcranial magnetic stimulation + magnetic stimulation Guan Yuan, Zhong Ji, Qi Hai

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

常规康复治疗+重复经颅磁刺激+普通针刺关元、中极、气海

干预措施代码：

Intervention：

Routine rehabilitation treatment + repeated transcranial magnetic stimulation + ordinary acupuncture Guan Yuan, Zhong Ji, Qi Hai

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

  

Country：

China 

Province：

Hebei 

City：

 

单位(医院)：

河北省人民医院 

单位级别：

三甲 

Institution
hospital：

Hebei Provincial People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

排尿日记

指标类型：

主要指标

Outcome：

Urination diary

Type：

Primary indicator

测量时间点：

治疗三周后

测量方法：

表格记录

Measure time point of outcome：

Three weeks after treatment

Measure method：

Tabular record

指标中文名：

最大膀胱容量

指标类型：

次要指标

Outcome：

Maximum bladder capacity

Type：

Secondary indicator

测量时间点：

治疗前及治疗三周后

测量方法：

彩超或间歇导尿

Measure time point of outcome：

Before and 3 weeks after treatment

Measure method：

Color ultrasound or intermittent catheterization

指标中文名：

残余尿量

指标类型：

次要指标

Outcome：

Residual urine output

Type：

Secondary indicator

测量时间点：

治疗前及治疗三周后

测量方法：

彩超或间歇导尿

Measure time point of outcome：

Before and 3 weeks after treatment

Measure method：

Color ultrasound or intermittent catheterization

指标中文名：

肌肉电生理学

指标类型：

次要指标

Outcome：

Muscle electrophysiology

Type：

Secondary indicator

测量时间点：

治疗前及治疗三周后

测量方法：

肌电图

Measure time point of outcome：

Before and 3 weeks after treatment

Measure method：

Electromyogram

指标中文名：

生活质量评分

指标类型：

次要指标

Outcome：

Quality of Life

Type：

Secondary indicator

测量时间点：

治疗前及治疗三周后

测量方法：

量表评估

Measure time point of outcome：

Before and 3 weeks after treatment

Measure method：

Scale evaluation

指标中文名：

美国国立卫生院卒中量表

指标类型：

次要指标

Outcome：

NIH Stroke Scale

Type：

Secondary indicator

测量时间点：

治疗前及治疗三周后

测量方法：

量表评估

Measure time point of outcome：

Before and 3 weeks after treatment

Measure method：

Scale evaluation

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 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）：

随机方法：由一名不参与评价指标和治疗过程的治疗师通过随机数字表法产生随机序列 ①编号：将研究对象按入院时间进行编号,1-60。②取随机数：从随机数字表（参考《医学统计学》第四版中的附表15）中任意一行任一列开始，一次读取60个相同位数的数字作为一个随机数录于编号下。③排序：将全部随机数从小到大编序号，将每个随机数字对应的序号记在表中。④分组：规定序号1-30为实验组，31-60为对照组。

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

1. Random method: A therapist who does not participate in the evaluation indicators and treatment process generates a random sequence through the random number table method.① Number: The subjects were numbered according to the time of admission,1-60. (2) Take random numbers: Starting from any row or column in the random number table (refer to Schedule 15 in the fourth edition of Medical Statistics), read 60 numbers of the same number at a time as a random number recorded under the number. ③ Sorting: all random numbers are numbered from small to large, and the corresponding serial number of each random number is recorded in the table. ④ Grouping: the serial number 1-30 is the experimental group,31-60 is 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:

不公开/Private

盲法：

①随机号由专门的人员负责产生，实验者、受试者事先不知情。②患者的最大膀胱容量、残余尿量由不知晓分配结果的同一名超声科医师完成。患者膀胱肌肉电生理测评由不知晓分配结果的同一名技师完成。患者的排尿日记、生活质量测评由不知晓分配结果且不参与治疗过程的同一名康复医师完成。③数据的分析和处理由不知晓分配结果且不参与治疗过程的研究人员进行。

Blinding：

Blind method:①The random number is generated by a special person, and the experimenter and the subject do not know in advance. ② The maximum bladder volume and residual urine volume of the patient were determined by the same sonographer who did not know the allocation results. The bladder muscle electrophysiological assessment was performed by the same technician who did not know the assignment results. The patient's urination diary and quality of life assessment were completed by the same rehabilitation physician who was not aware of the assignment results and was not involved in the treatment process.The data were analyzed and processed by researchers who were not aware of the assignment results and were not involved in the treatment process.

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）：

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：

病例记录表

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

Case Record Form, CRF

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：

  2024-04-10 11:23:17