中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400079574
最近更新日期： Date of Last Refreshed on：	2024-01-06 19:33:38
注册时间： Date of Registration：	2024-01-06 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	头针结合运动-认知双任务训练模式下轻度认知障碍患者认知功能改善及脑功能重塑研究
Public title：	Cognitive function improvement and brain function remodeling in patients with mild cognitive impairment under head acupuncture combined with motor and cognitive dual task training mode
注册题目简写：
English Acronym：
研究课题的正式科学名称：	头针结合运动-认知双任务训练模式下轻度认知障碍患者认知功能改善及脑功能重塑研究
Scientific title：	Cognitive function improvement and brain function remodeling in patients with mild cognitive impairment under head acupuncture combined with motor and cognitive dual task training mode
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：	郭媛媛	研究负责人：	郭媛媛
Applicant：	Yuanyuan Guo	Study leader：	Yuanyuan Guo
申请注册联系人电话： Applicant telephone：	+86 135 3305 6337	研究负责人电话： Study leader's telephone：	+86 135 3305 6337
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：	gyyst@163.com	研究负责人电子邮件： Study leader's E-mail：	gyyst@163.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：	广州市黄埔区港湾路621号	研究负责人通讯地址：	广州市黄埔区港湾路621号
Applicant address：	No.621 Gangwan Road, Huangpu District, Guangzhou	Study leader's address：	No.621 Gangwan Road, Huangpu District, Guangzhou
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：	广州医科大学附属第五医院
Applicant's institution：	The Fifth Affiliated Hospital of Guangzhou Medical University
研究负责人所在单位：	广州医科大学附属第五医院
Affiliation of the Leader：	The Fifth Affiliated Hospital of Guangzhou Medical University

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：	KY01-2023-11-02	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：	广州医科大学附属第五医院伦理委员会
Name of the ethic committee：	thics Committee of the Fifth Affiliated Hospital of Guangzhou Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2023-12-05 00:00:00
伦理委员会联系人：	王小宝
Contact Name of the ethic committee：	Xiaobao Wang
伦理委员会联系地址：	广州市黄埔区港湾路621号
Contact Address of the ethic committee：	No.621 Gangwan Road, Huangpu District, Guangzhou
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 20 8595 9127	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：

广州医科大学附属第五医院

Primary sponsor：

The Fifth Affiliated Hospital of Guangzhou Medical University

研究实施负责（组长）单位地址：

广州市黄埔区港湾路621号

Primary sponsor's address：

No.621 Gangwan Road, Huangpu District, Guangzhou

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：	Guangzhou
单位(医院)：	广州医科大学附属第五医院	具体地址：	广州市黄埔区港湾路621号
Institution hospital：	The Fifth Affiliated Hospital of Guangzhou Medical University	Address：	No.621 Gangwan Road, Huangpu District, Guangzhou

经费或物资来源：

广东省中医药局中医药科研项目

Source(s) of funding：

Chinese medicine research project of Guangdong Provincial Chinese Medicine Bureau

研究疾病：

轻度认知障碍

Target disease：

mild cognitive impairment(MCI)

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：

0

研究设计：

随机交叉对照

Study design：

Cross-over

研究目的：

① 通过健康受试者自身配对比较“头针同步运动认知双任务”范式与单纯“运动认知双任务”范式的疗效差异。 ② 验证“头针同步运动认知双任务”范式对于 MCI 患者的中枢神经响应和外周功能表现方面是否优于单纯“运动认知双任务”范式。

Objectives of Study：

① Comparing the efficacy difference between the "head acupuncture synchronous motor cognition dual task" paradigm and the simple "motor cognition dual task" paradigm through the matching of healthy subjects themselves. ② To verify whether the "head acupuncture synchronous motor cognition dual task" paradigm is better than the "motor cognition dual task" paradigm in terms of central nervous response and peripheral functional performance in MCI patients.

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

Healthy subjects: 
① The age is 20-80 years old (including 20 and 80 years old);
② MMSE is consistent with normal cognitive level; 
③ MoCA is consistent with normal cognitive level;  
④ no aphasia; 
⑤ no history of mental illness; 
⑥ No obvious organ function injury: including congestive heart failure, lower extremity deep vein thrombosis, malignant progressive hypertension, respiratory failure; Active liver disease, hepatic and renal insufficiency. 
⑦ Sign informed consent voluntarily.

Patients with MCI: 
① Age 50-80 years old (including 50 and 80 years old); 
② can walk independently without assistance (assistance includes: crutches or walking frames); 
③ Clinical Dementia Rating Scale (CDR) score was 0.5; 
④ Sign informed consent voluntarily; 
⑤ Meet the clinical diagnostic criteria for MCI: patients or informed persons report, or experienced clinicians find cognitive impairment; Objective evidence of impairment in one or more domains of cognitive function: memory, executive function, attention, and language; Complex instrumental daily abilities may be slightly impaired, but the ability to maintain independent daily living; The diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) has not yet met the diagnostic criteria for dementia. 
⑥ Patients with no obvious organ function impairment included congestive heart failure; Lower extremity deep vein thrombosis; Malignant progressive hypertension; Respiratory failure; Active liver disease; Liver and kidney dysfunction.

排除标准：

两组受试者均采用以下排除标准： ①　妊娠及哺乳期妇女； ②　存在影响步态的疾病，如偏瘫、帕金森病、骨折、膝关节病变、下肢关节损伤等； ③　既往有精神疾病史或服用抗精神病药物病史。

Exclusion criteria：

The following exclusion criteria were used in both groups: ① Pregnant and lactating women; ② There are diseases affecting gait, such as hemiplegia, Parkinson's disease, fracture, knee joint disease, lower limb joint injury, etc. ③ A history of mental illness or use of antipsychotic drugs.

研究实施时间：

Study execute time：

从 From 2024-02-01 00:00:00至 To 2025-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-02-01 00:00:00 至 To 2025-01-01 00:00:00

干预措施：

Interventions：

组别：	健康组-1	样本量：	10
Group：	Health group -1	Sample size：	10
干预措施：	健康组-1先进行“运动认知双任务”，干预30min（共1次），干预过程中同步进行fNIRS脑功能采集和Gaitrite步态参数采集。经过1周的洗脱期，进行“头针同步运动认知双任务”，干预30min（共1次），干预过程中同步进行fNIRS脑功能采集和Gaitrite步态参数采集。最后进行末期评估（同基线评估）。	干预措施代码：
Intervention：	The healthy group 1 first performed the "motor cognition dual task" and intervened for 30 minutes (once in total). FNIRS brain function and Gaitrite gait parameters were collected simultaneously during the intervention. After a one-week washout, the "dual task of synchronous movement cognition of the head needle" was performed, and the intervention was performed for 30 minutes (once total). During the intervention, the brain function collection of fNIRS and Gaitrite gait parameters were collected simultaneously. Finally, an end-stage assessment (same baseline assessment) was performed.	Intervention code：

组别：	健康组-2	样本量：	10
Group：	Health group -2	Sample size：	10
干预措施：	健康组-2先进行“头针同步运动认知双任务”，干预30min（共1次），干预过程中同步进行fNIRS脑功能采集和Gaitrite步态参数采集。经过1周的洗脱期，进行“运动认知双任务”，干预30min（共1次），干预过程中同步进行fNIRS脑功能采集和Gaitrite步态参数采集。最后进行末期评估（同基线评估）。	干预措施代码：
Intervention：	The healthy group 2 first performed the "dual task of synchronous movement cognition of head needle" and interfered for 30 minutes (once in total). FNIRS brain function and Gaitrite gait parameters were collected simultaneously during the intervention. After a one-week washout, the "motor cognition dual task" was performed, and the intervention was performed for 30 minutes (once total). FNIRS brain function and Gaitrite gait parameters were collected simultaneously during the intervention. Finally, an end-stage assessment (same baseline assessment) was performed.	Intervention code：

组别：	MCI-1	样本量：	20
Group：	MCI-1	Sample size：	20
干预措施：	MCI-1进行“头针同步运动认知双任务”训练，干预2周，5次/周，30min/次，干预过程中同步进行fNIRS脑功能采集和Gaitrite步态参数采集。并于干预前、干预1周时、干预2周后进行相关功能评估（同基线评估）。	干预措施代码：
Intervention：	MCI-1 was subjected to "dual task of synchronous movement cognition of head needle" training, and the intervention lasted for two weeks, five times/week, 30 minutes/ time. fNIRS brain function collection and Gaitrite gait parameter collection were performed simultaneously during the intervention. Relevant functional assessment was performed before intervention, at one week, and two weeks after intervention (same baseline assessment).	Intervention code：

组别：	MCI-2	样本量：	20
Group：	MCI-2	Sample size：	20
干预措施：	MCI-2进行“运动认知双任务”训练，干预2周，5次/周，30min/次，干预过程中同步进行fNIRS脑功能采集和Gaitrite步态参数采集。并于干预前、干预1周时、干预2周后进行相关功能评估（同基线评估）。	干预措施代码：
Intervention：	MCI-2 was trained with a "dual task of motor cognition" training, the intervention lasted for two weeks, five times/week, 30 minutes/ time. During the intervention, fNIRS brain function and Gaitrite gait parameter collection were carried out simultaneously. Relevant functional assessment was performed before intervention, at one week, and two weeks after intervention (same baseline assessment).	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东	市(区县)：	广州
Country：	China	Province：	Guangdong	City：	Guangzhou
单位(医院)：	广州医科大学附属第五医院	单位级别：	三甲
Institution hospital：	The Fifth Affiliated Hospital of Guangzhou Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	Gaitrite 步态分析参数	指标类型：	主要指标
Outcome：	Gaitrite Gait analysis parameters	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	fNIRS 脑功能检测指标	指标类型：	次要指标
Outcome：	fNIRS index of brain 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：	无	组织：
Sample Name：	NA	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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	20	岁 years
最大 Max age	80	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）：

简单随机方法（采用专门的项目组成员采用随机数表法生成随机数，并确定随机数字的分组）

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

Simple stochastic method

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：	单盲，对受试者隐藏分组
Blinding：	Single-blind, hidden grouping for subjects.

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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NA
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：	无
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	NA
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：	2024-01-06 19:33:33