三叉神经电刺激联合穴位针灸对意识障碍患者促醒的临床应用研究

注册号:

Registration number:

ITMCTR2024000562

最近更新日期:

Date of Last Refreshed on:

2024-10-15

注册时间:

Date of Registration:

2024-10-15

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

三叉神经电刺激联合穴位针灸对意识障碍患者促醒的临床应用研究

Public title:

Trigeminal nerve stimulation and acupuncture for prolonged disorders of consciousness

注册题目简写:

English Acronym:

研究课题的正式科学名称:

三叉神经电刺激联合穴位针灸对意识障碍患者促醒的临床应用研究

Scientific title:

Trigeminal nerve stimulation and acupuncture for prolonged disorders of consciousness

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:

黄慧仪

研究负责人:

伍少玲

Applicant:

Huiyi Huang

Study leader:

Shaoling Wu

申请注册联系人电话:

Applicant telephone:

13539997775

研究负责人电话:

Study leader's telephone:

13660183777

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:

489615911@qq.com

研究负责人电子邮件:

Study leader's E-mail:

13660183777@126.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:

广州市越秀区沿江西路107号

研究负责人通讯地址:

广州市越秀区沿江西路107号

Applicant address:

Yanjiangxi Road No.107 guangzhou guangdong

Study leader's address:

Yanjiangxi Road No.107 guangzhou guangdong

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:

中山大学孙逸仙纪念医院

Applicant's institution:

Sun Yat-sen Memorial Hospital Sun Yat-sen University

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:

SYSKY-2023-1284-02

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:

中山大学孙逸仙纪念医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University

伦理委员会批准日期:

Date of approved by ethic committee:

2024/2/4 0:00:00

伦理委员会联系人:

区柳珊

Contact Name of the ethic committee:

Liushan Ou

伦理委员会联系地址:

广东省广州市沿江西路107号

Contact Address of the ethic committee:

Yanjiangxi Road No.107 guangzhou guangdong

伦理委员会联系人电话:

Contact phone of the ethic committee:

020-81332587

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sysyxllwyh@163.com

研究实施负责(组长)单位:

中山大学孙逸仙纪念医院

Primary sponsor:

Sun Yat-sen Memorial Hospital Sun Yat-sen University

研究实施负责(组长)单位地址:

广州市越秀区沿江西路107号

Primary sponsor's address:

Yanjiangxi Road No.107 yuexiu district Guangzhou Guangdong 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学孙逸仙纪念医院

具体地址:

广州市越秀区沿江西路107号

Institution
hospital:

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Address:

Yanjiangxi Road No.107, yuexiu district, Guangzhou, Guangdong, China

经费或物资来源:

广州地区中西医协同临床重大创新技术建设项目(穗卫函〔2023〕2318号)

Source(s) of funding:

Major Innovation Technology Construction Project of Synergistic Chinese Medicine and Western Medicine of Guangzhou (No.2023-2318)

研究疾病:

慢性意识障碍

研究疾病代码:

Target disease:

prolonged disorders of consciousness

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:

其它

Others

研究目的:

通过三叉神经电刺激联合真针刺与三叉神经电刺激联合假针刺对慢性意识障碍患者对比,观察三叉神经电刺激联合针刺对慢性意识障碍患者促醒的临床疗效及作用机制。

Objectives of Study:

To observe the efficacy of trigeminal nerve stimulation and acupuncture in the treatment of prolonged disorders of consciousness and to investigate its mechanism.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①年龄≥18岁; ②经昏迷恢复量表修订版(Coma Recovery Scale-Revised,CRS-R)诊断为植物状态(VS)或微小意识状态(MCS); ③意识障碍持续时间≥28天; ④患者家属自愿参加本项目,并签署知情同意书。

Inclusion criteria

(1) age ≥ 18 years; ;(2) diagnosed as vegetative state (VS) or minimally consciousness state (MCS) according to the clinical diagnostic criteria and coma recovery scale-revised (CRS-R); (3) duration of loss of consciousness>28 days; (4) patient's family members voluntarily participate in the project and sign the informed consent.

排除标准:

①长期依赖镇静麻醉药等显著影响意识状态评估的药物; ②存在电磁相关治疗的禁忌,如使用植入式电子装置(如心脏起搏器); ③颅骨缺损; ④局部皮肤损伤或感染者; ⑤合并严重精神疾病、癫痫; ⑥合并其他系统严重疾病(如心、肝、肾等功能衰竭或严重感染)。

Exclusion criteria:

(1) long-term dependence on sedatives anesthetics and other drugs that significantly affect the assessment of conscious states; (2) contraindications in electromagnetic related treatment such as the use of implantable electronic devices (such as pacemakers); (3) skull defect; (4) local skin injury or infection; (5) combined with serious mental illness epilepsy; (6) combined with other serious diseases of the system (such as heart liver kidney and other function failure or serious infection).

研究实施时间:

Study execute time:

From 2024-10-30

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2024-10-30

To      2026-12-31

干预措施:

Interventions:

组别:

三叉神经电刺激联合假针刺组

样本量:

30

Group:

TNS+ sham acupuncture

Sample size:

干预措施:

三叉神经电刺激联合假针刺

干预措施代码:

Intervention:

TNS+ sham acupuncture

Intervention code:

组别:

三叉神经电刺激联合针刺组

样本量:

30

Group:

TNS+acupuncture

Sample size:

干预措施:

三叉神经电刺激联合针刺

干预措施代码:

Intervention:

TNS+acupuncture

Intervention code:

样本总量 Total sample size : 60

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

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学孙逸仙纪念医院

单位级别:

三甲

Institution/hospital:

广州市越秀区沿江西路107号

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

诱发电位

指标类型:

次要指标

Outcome:

Evoked 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:

CRS-R 量表评分

指标类型:

主要指标

Outcome:

CRS-R score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

GCS量表评分

指标类型:

次要指标

Outcome:

GCS score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

近红外功能成像

指标类型:

次要指标

Outcome:

Near infrared functional imaging

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大
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):

对项目设计不知情的数据管理员通过计算机软件产生随机序列。

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

Random sequences were generated by computer software by data managers who were blinded to the project design.

盲法:

参与者、结果评估者和统计学家在分组分配方面设盲。

Blinding:

Participants outcome evaluators and statisticians were blinded in grouping assignments.

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):

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:

我们将通过CRF采集数据。

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

We will collect data through Case Report Form(CRF).

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):

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

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统