Today is 2022-05-24

Transcranial Direct Current Stimulation in Post-Stroke Fatigue
download

注册号:

Registration number:

ChiCTR2100052515 

最近更新日期:

Date of Last Refreshed on:

2021-10-30 

注册时间:

Date of Registration:

2021-10-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Transcranial Direct Current Stimulation in Post-Stroke Fatigue 

Public title:

Transcranial Direct Current Stimulation in Post-Stroke Fatigue 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Transcranial Direct Current Stimulation in Post-Stroke Fatigue: A Double-blind Randomised Control Trial 

Scientific title:

Transcranial Direct Current Stimulation in Post-Stroke Fatigue: A Double-blind Randomised Control Trial 

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:

TANG Wai Kwong 

研究负责人:

TANG Wai Kwong 

Applicant:

TANG Wai Kwong 

Study leader:

TANG Wai Kwong 

申请注册联系人电话:

Applicant telephone:

+852 3919 7754 

研究负责人电话:

Study leader's telephone:

+852 3919 7754 

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:

tangwk@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

tangwk@cuhk.edu.hk 

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:

Shatin Hospital, Hong Kong SAR, China 

研究负责人通讯地址:

Shatin Hospital, Hong Kong SAR, China 

Applicant address:

Shatin Hospital, Hong Kong SAR, China 

Study leader's address:

Shatin Hospital, Hong Kong SAR, 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:

香港中文大學 

Applicant's institution:

The Chinese University of Hong Kong 

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:

2020.550-T 

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:

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會 

Name of the ethic committee:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-12-01 

伦理委员会联系人:

Envy Lee 

Contact Name of the ethic committee:

Envy Lee 

伦理委员会联系地址:

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓 

Contact Address of the ethic committee:

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

None 

Primary sponsor:

None 

研究实施负责(组长)单位地址:

Not applicable 

Primary sponsor's address:

Not applicable 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

None 

Source(s) of funding:

None 

研究疾病:

Stroke 

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:

探索性研究/预试验 

Study phase:

研究目的:

To examine the effect of tDCS in poststroke fatigue 

Objectives of Study:

To examine the effect of tDCS in poststroke fatigue 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1) 男女均可; 2) 18 歲或以上; 3) 任何教育或識字水平; 4) 有據可查的中風發生; 5) 華裔及會流利粵語; 6) 能給予知情同意的能力和意願; 7) 慣用右手; 8) 擁有由 FSS 分數定義的 PSF。 

Inclusion criteria

1. both male and female; 2. at least 18 years old; 3. any level of education or literacy; 4. well-documented stroke occurring; 5. Chinese ethnicity and fluency in the Cantonese dialect; 6. ability and willingness to give informed consent; 7. right-handed; 8. Presence of PSF as defined by the FSS score.  

排除标准:

1) 抑鬱症史或老年抑鬱量表 (Chau et al. 2006) 7 分或以上; 2) 雙相情感障礙、精神分裂症和/或酒精/藥物濫用/依賴; 3) 除中風外的任何神經系統疾病史; 4) 癲癇病史、外傷性腦損傷、發作性睡病、睡眠呼吸暫停、癌症或甲狀腺功能減退症; 5) 自我報告的不明原因昏厥史; 6) 懷孕; 7)自述沒有做過神經外科手術; 8) 癡呆,定義為 MMSE 分數低於 20 (Chiu et al. 1994); 9) 中風後抑鬱症,定義為精神科醫生使用 DSM-IV 的結構化臨床訪談(Kam 2000)和根據 DSM-V 診斷標準(美國精神病學協會 2013 年)評估為重度抑鬱症; 10) 服用已知會影響疲勞的藥物,例如催眠藥; 11) 服用已知可降低 tDCS 作用的藥物,如抗癲癇藥; 12) 以前或當前使用 tDCS; 13) tDCS 的禁忌症,例如刺激部位的皮膚受損、攜帶起搏器、頭部金屬和植入的腦部醫療設備。 

Exclusion criteria:

1. history of depression or Geriatric Depression Scale (Chau et al. 2006) score of seven or more; 2. bipolar disorder, schizophrenia and/or alcohol/substance abuse/dependence; 3. history of any neurological disease other than stroke; 4. history of epilepsy, traumatic brain injury, narcolepsy, sleep apnoea, cancer or hypothyroidism; 5. history of unexplained fainting spells as self-reported; 6. Pregnancy; 7. have had no neurosurgery as self reported; 8. dementia, defined as an MMSE score of less than 20 (Chiu et al. 1994); 9. poststroke depression, defined as the presence of major depression as assessed by a psychiatrist using the Structured Clinical Interview for DSM-IV (Kam 2000) and according to the DSM-V Diagnostic Criteria (American Psychiatric Association 2013); 10. taking medications known to inflcuence fatigue, such as hypntoics; 11. taking medications known to reduce the effect of tDCS, such as antipeileptic drugs; 12. previous or current use of tDCS; 13. contraindications to tDCS such as damaged skin at the site of stimulation, carrying a pacemaker, metal in the head, and implanted brain medical devices. 

研究实施时间:

Study execute time:

From2023-01-01To 2025-12-31 

征募观察对象时间:

Recruiting time:

From2023-01-01To 2025-12-31 

干预措施:

Interventions:

组别:

Two groups

样本量:

28

Group:

Two groups

Sample size:

干预措施:

tDCS

干预措施代码:

Intervention:

tDCS

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

Hong Kong 

单位(医院):

香港中文大學 

单位级别:

三级医院 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

Teritary 

测量指标:

Outcomes:

指标中文名:

Fatigue

指标类型:

主要指标 

Outcome:

Fatigue

Type:

Primary 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:

组织:

Sample Name:

None

Tissue:

None

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 18 years
最大 Max age 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):

Tony Leung 先生將通過RANDOM.ORG 網站上列出的隨機數生成器生成隨機數。

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

Mr. Tony Leung will generate the random number by the random number generator listed in the RANDOM.ORG website.

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
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):

IPD 可以通過聯繫首席調查員獲得

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

IPD can be obtained by contacting the lead investigator

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:

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

None

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-10-30
return list