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【ChiCTR2400093928】Impact of calligraphy practice on functional brain network

基本信息
登记号

ChiCTR2400093928

试验状态

尚未开始

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2024-12-13

临床申请受理号

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靶点

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适应症

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试验通俗题目

Impact of calligraphy practice on functional brain network

试验专业题目

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

申办单位信息
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联系人邮编

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临床试验信息
试验目的

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.

试验分类
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试验类型

随机平行对照

试验分期

其它

随机化

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.

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.

试验项目经费来源

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试验范围

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目标入组人数

100

实际入组人数

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第一例入组时间

2025-01-01

试验终止时间

2027-12-31

是否属于一致性

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入选标准

Inclusion criteria are ethnic Chinese, aged 55 to 75 years, right-handed, living at home, and experiencing SCD as defined by i) scoring above the age- and education-specific cutoff for MCI (i.e., cognitive test performance within normal range) in the Hong Kong Chinese version of Montreal Cognitive Assessment (MoCA), and ii) answering yes to at least one question in the Abbreviated Memory Inventory for Chinese, a locally validated screening tool for SCD.;

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.;

研究者信息
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试验机构

Chinese University of Hong Kong

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研究负责人邮编

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