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Impact of calligraphy practice on functional brain network
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注册号：

Registration number：

 ChiCTR2400093928 

最近更新日期：

Date of Last Refreshed on：

 2024-12-13 14:39:23 

注册时间：

Date of Registration：

 2024-12-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Impact of calligraphy practice on functional brain network

Public title：

Impact of calligraphy practice on functional brain network

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effect of calligraphy practice on modulating default mode network in older adults at risk of dementia – a randomized controlled trial

Scientific title：

Effect of calligraphy practice on modulating default mode network in older adults at risk of dementia – a randomized controlled 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：

Allen Lee 

研究负责人：

Allen Lee 

Applicant：

Allen Lee 

Study leader：

Allen Lee 

申请注册联系人电话：

Applicant telephone：

 +852 2607 6031

研究负责人电话：

Study leader's
telephone：

+852 2607 6031

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：

 allenlee@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 allenlee@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：

CUHK Department of Psychiatry, G/F, Multi-Centre, Tai Po Hospital, Tai Po, New Territories, Hong Kong

研究负责人通讯地址：

CUHK Department of Psychiatry, G/F, Multi-Centre, Tai Po Hospital, Tai Po, New Territories, Hong Kong

Applicant address：

CUHK Department of Psychiatry, G/F, Multi-Centre, Tai Po Hospital, Tai Po, New Territories, Hong Kong

Study leader's address：

CUHK Department of Psychiatry, G/F, Multi-Centre, Tai Po Hospital, Tai Po, New Territories, Hong Kong

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：

Chinese University of Hong Kong

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

Chinese University of Hong Kong

Affiliation of the Leader：

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：

 2023.566

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：

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

Name of the ethic committee：

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

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-11 00:00:00

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：

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

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：

 +852 3505 3824

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec2@cuhk.edu.hk

研究实施负责（组长）单位：

Chinese University of Hong Kong

Primary sponsor：

Chinese University of Hong Kong

研究实施负责（组长）单位地址：

University Road, Sha Tin District, Hong Kong Special Administrative Region, China

Primary sponsor's address：

University Road, Sha Tin District, Hong Kong Special Administrative Region, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Chinese University of Hong Kong

具体地址：

University Road, Sha Tin District, Hong Kong Special Administrative Region, China

Institution
hospital：

Chinese University of Hong Kong

Address：

University Road, Sha Tin District, Hong Kong Special Administrative Region, China

经费或物资来源：

Source(s) of funding：

Research Grants Council

研究疾病：

 

Target disease：

Subjective Cognitive Decline

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The primary objective is to examine the effect of calligraphy practice on functional connectivities (FCs) within DMN. The secondary objective is to examine the effect of calligraphy practice on cognitive functions.  

Objectives of Study：

The primary objective is to examine the effect of calligraphy practice on functional connectivities (FCs) within DMN. The secondary objective is to examine the effect of calligraphy practice on cognitive functions.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Exclusion criteria include living in care homes; known MCI or clinical dementia; having history of stroke, traumatic brain injury, Parkinson’s disease, epilepsy, brain tumor, or prior operation to the brain; taking drugs that affect cognition (benzodiazepines, cognitive enhancers, etc.); having history of depression, bipolar affective disorder, psychosis, or substance abuse; having significant impairment in communication, writing or mobility; previously learned or already practising Chinese calligraphy handwriting; already attending other cognitive interventions or participating regularly in other cognitive activities (≥1 hour per week; cognitive activities defined by the validated classification system of leisure activities in local older Chinese adults); and having magnetic resonance imaging (MRI) contraindications.

Exclusion criteria：

Exclusion criteria include living in care homes; known MCI or clinical dementia; having history of stroke, traumatic brain injury, Parkinson’s disease, epilepsy, brain tumor, or prior operation to the brain; taking drugs that affect cognition (benzodiazepines, cognitive enhancers, etc.); having history of depression, bipolar affective disorder, psychosis, or substance abuse; having significant impairment in communication, writing or mobility; previously learned or already practising Chinese calligraphy handwriting; already attending other cognitive interventions or participating regularly in other cognitive activities (≥1 hour per week; cognitive activities defined by the validated classification system of leisure activities in local older Chinese adults); and having magnetic resonance imaging (MRI) contraindications.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-01-01 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

Control group

样本量：

 100

Group：

Control group

Sample size：

干预措施：

Health education

干预措施代码：

Intervention：

Health education

Intervention code：

组别：

Intervention group

样本量：

 100

Group：

Intervention group

Sample size：

干预措施：

Calligraphy practice

干预措施代码：

Intervention：

Calligraphy practice

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Functional connectivities

指标类型：

主要指标

Outcome：

Functional connectivities

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cognitive function

指标类型：

次要指标

Outcome：

Cognitive function

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：

nil

组织：

Sample Name：

nil

Tissue：

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 55 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）：

Participants will be randomly allocated to either the intervention or control group in a 1:1 ratio using a central computer-generated random number sequence.

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

Participants will be randomly allocated to either the intervention or control group in a 1:1 ratio using a central computer-generated random number sequence.

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：

Research staff who assist in intervention will not assess outcomes, and those who assess outcomes will be blinded to allocation and not involved in intervention delivery.

Blinding：

Research staff who assist in intervention will not assess outcomes, and those who assess outcomes will be blinded to allocation and not involved in intervention delivery.

是否共享原始数据：

IPD sharing

否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）：

to be announced

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

to be announced

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：

to be announced

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

to be announced

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：

  2024-12-13 14:39:00
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