ChiCTR2300076059 版本V1.0 版本创建时间2023/09/22 17:28:06 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：

ChiCTR2300076059 

最近更新日期：

Date of Last Refreshed on：

2023-09-22 17:28:02 

注册时间：

Date of Registration：

2023-09-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

面向瘫痪患者下肢运动想象机制及应用的研究

Public title：

Study on the mechanism and application of lower limb motor imagination in patients with paralysis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

面向瘫痪患者下肢运动想象机制及应用的研究

Scientific title：

Study on the mechanism and application of lower limb motor imagination in patients with paralysis

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：

尹杰 

研究负责人：

王文春 

Applicant：

Yin Jie 

Study leader：

Wang Wenchun 

申请注册联系人电话：

Applicant telephone：

+86 132 5606 9139

研究负责人电话：

Study leader's telephone：

+86 189 0806 9418

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：

yinjie01180402@163.com

研究负责人电子邮件：

Study leader's E-mail：

wwc1977@foxmail.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：

四川省成都市金牛区蓉都大道270号西部战区总医院康复医学科

研究负责人通讯地址：

四川省成都市金牛区蓉都大道270号西部战区总医院康复医学科

Applicant address：

Department of Rehabilitation Medicine, General Hospital of Western Theater Command of PLA, 270 Rongdu Avenue, Jinniu District, Chengdu, Sichuan

Study leader's address：

Department of Rehabilitation Medicine, General Hospital of Western Theater Command of PLA, 270 Rongdu Avenue, Jinniu District, Chengdu, Sichuan

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：

西部战区总医院

Applicant's institution：

General Hospital of Western Theater Command of PLA

研究负责人所在单位：

西部战区总医院

Affiliation of the Leader：

General Hospital of Western Theater Command of PLA

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：

2022EC1-017

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：

西部战区总医院伦理委员会

Name of the ethic committee：

The Ethics Committee of the General Hospital of Western Theater Command of PLA

伦理委员会批准日期：

Date of approved by ethic committee：

2022-01-25 00:00:00

伦理委员会联系人：

杨海伟

Contact Name of the ethic committee：

Yang Haiwei

伦理委员会联系地址：

四川省成都市金牛区蓉都大道天回路270号

Contact Address of the ethic committee：

270 Tianhuan Road, Rongdu Avenue, Jinniv District, Chengdu, Sichuan

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 8657 1215

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：

西部战区总医院

Primary sponsor：

General Hospital of Western War Zone

研究实施负责（组长）单位地址：

成都市金牛区蓉都大道270号

Primary sponsor's address：

270 Rongdu Avenue, Jinniv District, Chengdu

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

西部战区总医院

具体地址：

金牛区蓉都大道270号

Institution
hospital：

General Hospital of Western War Zone

Address：

270 Rongdu Avenue, Jinniv District

经费或物资来源：

四川省科技计划重点研发项目专项经费（2020YFS0168)

Source(s) of funding：

Special funds for key research and development projects of Sichuan Science and Technology Plan (2020YFS0168)

Target disease：

Paralysis (Stroke & Spinal cord injury)

Target disease code：

研究类型：

基础科学研究

Study type：

Basic Science

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

伴随着中国步入老龄化社会以及城市化进程加速，以及居民存在不健康的生活方式，导致脑血管疾病的发生，以及现代化交通方式、高空作业等特殊工作环境，导致脊髓损伤的发生。而针对瘫痪患者的康复治疗训练依赖于患者的物理锻炼，而运动想象是一种对身体不发生动作的运动的想象训练，是患者大脑中对动作预演的一种行为方式，为瘫痪患者提供了一种不依靠残余运动功能的代替神经康复治疗的方法。而脑机接口技术能够使运动想象这种内心活动具现化，能够直观的观察到患者是否想象成功。但目前基于运动想象的脑机接口多是以健康人上肢运动作为研究对象，在应用在瘫痪患者身上时，解码效率降低导致脑机接口性能降低，为了分析比较瘫痪患者与健康人在进行下肢运动想象脑电信号的差异开展本研究，旨在推动运动想象脑机接口的泛化能力，扩大适用用户。  

Objectives of Study：

As China enters an aging society and the process of urbanization accelerates, as well as the unhealthy lifestyle of residents, cerebrovascular diseases occur, as well as special working environments such as modern transportation modes and high-altitude work, resulting in spinal cord injury. The rehabilitation treatment training for patients with paralysis depends on the physical exercise of the patient, while the movement imagination is a kind of imagination training for the movement of the body without action, and a behavior mode of the patient's brain to rehearse the action, providing a method for the paralyzed patients to replace the neurological rehabilitation treatment without relying on the residual motor function. The brain-computer interface technology can make the inner activity of motor imagination vivid, and can intuitively observe whether the patient has successfully imagined. However, the current brain-computer interface based on motor imagination is mostly based on the upper limb movement of healthy people as the research object. When applied to paralyzed patients, the decoding efficiency is reduced, resulting in the performance of brain-computer interface is reduced. In order to analyze and compare the differences between paralyzed patients and healthy people in the lower limb motor imagination EEG signal, this study aims to promote the generalization ability of motor imagination brain-computer interface. Expand the applicable users.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

脑卒中偏瘫患者：1）符合缺血性脑卒中诊断标准；2）纳入时间在六个月内的受试者；3）年龄在18~85岁之间（性别无特殊要求）；4）皮肤保持完整性，四肢结构完整；5）受试者能够理解研究目的，显示对研究方案足够的依从性，并签署知情同意书。 脊髓损伤截瘫患者：1）经研究者诊断为脊髓损伤恢复期，损伤平面胸段及腰段；2）采用美国脊髓损伤协会（American Spinal Injury Association，ASIA）脊髓损伤国际标准神经学分类，对脊髓损伤患者的神经平面进行评定，ASIA分级C或D；3）年龄在18~85岁之间（性别无特殊要求）；4）皮肤保持完整性，四肢结构完整；5）受试者能够理解研究目的，显示对研究方案足够的依从性，并签署知情同意书。 正常人：1）既往无癫痫、脑血管病及精神病病史，无脑部器质性病变；2）一般状况良好，除一般慢性基础疾病外无严重的原发或继发性疾病；3）年龄在18~85岁之间（性别无特殊要求）；4）皮肤保持完整性，四肢结构完整；5）受试者能够理解研究目的，显示对研究方案足够的依从性，并签署知情同意书。

Inclusion criteria

Stroke patients with hemiplegia: 1) meet the diagnostic criteria for ischemic stroke; 2) Participants enrolled within six months; 3) Age between 18 and 85 years old (gender no special requirements); 4) The skin remains intact and the limbs are structurally intact; 5) The subject is able to understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent. Patients with spinal cord injury and paraplegia: 1) were diagnosed by the researchers as recovering from spinal cord injury, and the injured plane was thoracic and lumbar segments; 2) The neural plane of patients with Spinal cord Injury was evaluated using the American Spinal Injury Association (ASIA) International Standard neurological classification of spinal cord injury (ASIA grade C or D); 3) Age between 18 and 85 years old (gender no special requirements); 4) The skin remains intact and the limbs are structurally intact; 5) The subject is able to understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent. Normal person: 1) no previous history of epilepsy, cerebrovascular disease and mental illness, no organic brain lesions; 2) Generally in good condition, with no serious primary or secondary diseases except general chronic underlying diseases; 3) Age between 18 and 85 years old (gender no special requirements); 4) The skin remains intact and the limbs are structurally intact; 5) The subject is able to understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent.

排除标准：

脑卒中偏瘫患者：1）既往癫痫病史；2）患有精神类疾病；3）既往脑卒中史；4）施有开颅手术或进行补全颅骨手术；5）美国国立卫生研究院卒中量表（ NIHSS ）评分大于20分；6）影像学检查确诊为皮层梗死；（7）经检查证实由脑肿瘤、脑外生、血液病等引起的中风患者；8）脑电图前24h内使用过镇静催眠、抗癫痫及精神病药物；9）意识障碍、失语、严重痴呆状况、严重视力、听力障碍不能配合临床调查者；10）合并有严重的心血管、髙血压、消化、造血系统、肝、肾等原发性疾病，生命体征不平稳，难以配合检查者。 脊髓损伤截瘫患者：1）既往癫痫病史；2）患有精神类疾病；3）既往脑卒中史；4）影像学检查确诊为皮层梗死；5）经检查证实由脑肿瘤、脑外生、血液病等引起的中风患者；6）脑电图前24h内使用过镇静催眠、抗癫痫及精神病药物；7）意识障碍、失语、严重痴呆状况、严重视力、听力障碍不能配合临床调查者；8）合并有严重的心血管、髙血压、消化、造血系统、肝、肾等原发性疾病，生命体征不平稳，难以配合检查者。 正常人：1）既往癫痫病史；2）患有精神类疾病；3）既往脑卒中史；4）施有开颅手术或进行补全颅骨手术；5）脑电图前24h内使用过镇静催眠、抗癫痫及精神病药物；6）意识障碍、失语、严重痴呆状况、严重视力、听力障碍不能配合临床调查者；7）合并有严重的心血管、髙血压、消化、造血系统、肝、肾等原发性疾病，生命体征不平稳，难以配合检查者。

Exclusion criteria：

Stroke patients with hemiplegia: 1) previous history of epilepsy; 2) suffering from mental illness; 3) Previous history of stroke; 4) Craniotomy or cranioplasty was performed; 5) National Institutes of Health Stroke Scale (NIHSS) score greater than 20 points; 6) Cortical infarction was confirmed by imaging examination; (7) Stroke patients who have been confirmed by examination to be caused by brain tumors, brain exogenesis, blood diseases, etc.; 8) Sedative hypnosis, antiepileptic and psychotic drugs were used within 24h before EEG; 9) Disorder of consciousness, aphasia, severe dementia, severe vision and hearing impairment can not cooperate with clinical investigators; 10) Complicated with serious cardiovascular, high blood pressure, digestive, hematopoietic system, liver, kidney and other primary diseases, vital signs are unstable, difficult to cooperate with the examination. Patients with spinal cord injury and paraplegia: 1) previous history of epilepsy; 2) suffering from mental illness; 3) Previous history of stroke; 4) Imaging examination confirmed cortical infarction; 5) Stroke patients confirmed by examination to be caused by brain tumors, brain exogenesis, blood diseases, etc.; 6) Sedative hypnosis, antiepileptic and psychotic drugs were used within 24h before EEG; 7) Consciousness disorder, aphasia, severe dementia, severe vision and hearing impairment can not cooperate with clinical investigators; 8) Complicated with serious cardiovascular, high blood pressure, digestive, hematopoietic system, liver, kidney and other primary diseases, vital signs are unstable, difficult to cooperate with the examination. Normal people: 1) History of epilepsy; 2) suffering from mental illness; 3) Previous history of stroke; 4) Craniotomy or cranioplasty was performed; 5) Sedative hypnosis, antiepileptic and psychotic drugs were used within 24h before EEG; 6) Disorder of consciousness, aphasia, severe dementia, severe vision and hearing impairment can not cooperate with clinical investigators; 7) Complicated with serious cardiovascular, high blood pressure, digestive, hematopoietic system, liver, kidney and other primary diseases, vital signs are unstable, difficult to cooperate with the examination.

研究实施时间：

Study execute time：

从 From 2021-12-01 00:00:00至 To 2023-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2022-01-25 00:00:00 至 To 2022-11-01 00:00:00  

干预措施：

Interventions：

组别：

脑卒中组

样本量：

8

Group：

Stroke group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

脊髓损伤组

样本量：

8

Group：

Spinal cord injury group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

正常人组

样本量：

8

Group：

Normal group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

西部战区总医院 

单位级别：

三级甲等  

Institution
hospital：

General Hospital of Western War Zone

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

脑网络

指标类型：

主要指标

Outcome：

Brain network

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

事件相关电位

指标类型：

次要指标

Outcome：

Event-related potential

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

事件相关同步/去同步

指标类型：

次要指标

Outcome：

Event-related (de)synchronization

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 85 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）：

不适用

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

N/A

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：

无

Blinding：

None

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）：

Resman

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：

脑电帽、EEGO软件

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

EEG cap, EEGO software

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：

  2023-09-22 17:28:02