针刺对aMCI脑功能网络时效及靶向调节效应机制研究

注册号:

Registration number:

AMCTR-ROC-18000233 

注册号获得时间:

Date of releasing the registration number:

2018/12/20 9:50:33 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺对aMCI脑功能网络时效及靶向调节效应机制研究 

Public title:

Study for acupuncture on time and targeting regulation mechanism of aMCI brain functional network 

研究课题的正式科学名称:

针刺对aMCI脑功能网络时效及靶向调节效应机制研究 

Scientific title:

Study for acupuncture on time and targeting regulation mechanism of aMCI brain functional network 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800019898 

申请注册联系人:

崔韶阳 

研究负责人:

崔韶阳 

Applicant:

Shaoyang Cui 

Study leader:

Shaoyang Cui 

申请注册联系人电话:

Applicant telephone:

+86 15112491899 

研究负责人电话:

Study leader's telephone:

+86 15112491899 

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:

herb107@126.com 

研究负责人电子邮件:

Study leader's E-mail:

herb107@126.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:

深圳市福田区北环大道6001号 

研究负责人通讯地址:

深圳市福田区北环大道6001号 

Applicant address:

6001 Beihuan Road, Futian District, Shenzhen, Guangdong, China 

Study leader's address:

6001 Beihuan Road, Futian District, Shenzhen, Guangdong, 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:

广州中医药大学深圳医院(福田) 

Applicant's institution:

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian) 

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:

201820 

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:

广州中医药大学深圳医院(福田)伦理委员会 

Name of the ethic committee:

Ethics Committee of Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian) 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-27 

研究实施负责(组长)单位:

广州中医药大学深圳医院(福田) 

Primary sponsor:

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian) 

研究实施负责(组长)单位地址:

深圳市福田区北环大道6001号 

Primary sponsor's address:

6001 Beihuan Road, Futian District, Shenzhen, 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):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

广州中医药大学深圳医院(福田)

具体地址:

深圳市福田区北环大道6001号

Institution
hospital:

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

Address:

6001 Beihuan Road, Futian District, Shenzhen, Guangdong, China

经费或物资来源:

广东省科技厅,深圳市三名工程项目 

Source(s) of funding:

Science and Technology Department of Guangdong Province,Shenzhen Special Fund for Introducing High-Level Medical Team Project (2015) 

研究疾病:

遗忘型轻度认知功能障碍 

Target disease:

Amnestic mild cognitive impairment 

研究疾病代码:

 

Target disease code:

 

研究类型:

相关因素研究 

Study type:

Relative factors research 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

(1)基于静息态fMRI 脑功能网络分析,对aMCI 患者与正常受试者比较,进一步明确aMCI患者静息状态脑功能网络的病变脑区及其网络连接病理特点。(2)基于ALFF 和功能连接方法,明确针刺疗法的中枢网络调控效应机制。 

Objectives of Study:

(1) Based on the analysis of resting-state fMRI brain functional network,clarify the pathological characteristics of brain functional network in aMCI patient by comparing with normal subjects; (2) Based on ALFF and functional connection method, clarify the regulation mechanism of central network of acupuncture therapy. 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

一、遗忘型轻度认知障碍患者 (1)主诉记忆减退,并经知情者证实,症状持续时间>6 个月。 (2)临床评估证实有认知障碍,记忆型病例的逻辑记忆损害如延迟故事回忆(Delayed Story Recall,DSR)得分比年龄或教育匹配人群的平均水准至少低1.5SD;非记忆型病例的执行功能或视空间能力损害如画钟测验(Clock Draw Test,CDT)得分比年龄或教育匹配人群的平均水准低1.0SD 以上;语言功能损害如言语分类流畅性测验(Verbal Category FluencyTest,VCFT)得分比年龄或教育匹配人群的平均水准低1.0SD 以上;认知型病例至少有两项认知领域的损害,分别比年龄和教育匹配人群的平均值低1.0SD,其严重程度达不到痴呆标准。 (3)简易精神状态检查(Mini-mental State Examination,MMSE)得分在24-30 之间。 (4)临床痴呆分级量表(Clinical Dementia Rating,CDR)0.5 分,遗忘型CDR 量表记忆项得分至少0.5 分。 (5)总的认知功能充分保存,如 AD 评价量表-认知部分(Alzheimer’S Disease Assessment Scale-cognitive subscale,ADAS-cog)得分11-17 分之间。 (6)日常生活活动完好或有非常轻微的损害,如工具性日常生活活动(Instrumental Activities of Daily Living,IADL)得分大于或等于16 分。 (7)年龄在 50 岁及以上,均为右利手。 (8)有足够的视觉和听觉分辨力接受神经心理学测试。 (9)良好的整体健康而无其他可能会干扰药物试验的疾病。 (10)签署知情同意书,知情人(与受试者经常联系,每周平均10h 以上)同意参与试验研究,观察副作用事件和陪伴受试者在试验期间就诊。 (11)允许筛选前至少1 个月内服用的药物包括无明显抗胆碱能副作用和稳定剂量的抗抑郁药(如果患者目前没有抑郁和过去2 年内没有主要抑郁症史)、雌激素替代疗法以及银杏制剂(允许,但不鼓励)。 (12)aMCI筛选之前12 个月内CT 或核磁共振成像(magnetic resonance imaging,MRI)扫描无感染、梗死或其他局灶性损伤的证据,也无相关临床症状,但允许一个非关键性脑区域的腔隙性梗死且不被认为影响了受试者的认知损害;Hachinski 缺血量表(Hachinski Ischemia Scale HIS)得分小于或等于4 分。 二、正常人群对照组 (1)年龄为 55-70 岁,汉族,右利手,总体健康情况良好,无神经系统疾病; (2)无记忆障碍主诉及临床表现; (3)总体认知功能正常,简易精神状态检查量表(MMSE)>27 分; (4)日常生活能力良好,日常生活能力量表(ADL)<26 分; (5)无认知障碍减退,临床痴呆量表(CDR)=0。 

Inclusion criteria

1. Patients with amnestic mild cognitive impairment (1) The complaint of memory loss was confirmed by the person who knew it. The duration of symptoms was longer than 6 months; (2) Clinical evaluation confirmed cognitive impairment. Logical memory impairment such as Delayed Story Recall (DSR) score in memory-type cases was at least 1.5 SD lower than the average of age-or education-matched population; executive function or visual-spatial impairment in non-memory-type cases such as Clock Draw Test (CDT) Scores were 1.0 SD lower than the average level of age-matched or education-matched people; scores of language dysfunction such as Verbal Category Fluency Test (VCFT) were 1.0 SD lower than the average level of age-matched or education-matched people; and cognitive cases had at least two cognitive impairments, respectively 1.0SD lower, compared with age and education-matched people,and the severity could not meet the dementia standard; (3) Mini-mental State Examination (MMSE) scored between 24 and 30; (4) Clinical Dementia Rating (CDR) scored 0.5, and amnesia CDR scored at least 0.5; (5) The overall cognitive function was fully preserved, such as the score of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) between 11 and 17; (6) Activities of daily life are intact or very slightly impaired, such as Instrumental Activities of Daily Living (IADL) score greater than or equal to 16; (7) Older than 50 yeas, and right-handed; (8) Good vision and hearing to undergo neuropsychological tests; (9) Health, no use of drugs which can interference the test; (10) Sign the informed consent form, and the informed person (contacting the subjects regularly, averaging more than 10 hours a week) agrees to participate in the experimental study, observe the side effects and accompany the subjects to see a doctor during the experiment; (11) Drugs administered at least one month before screening include antidepressants with no significant anticholinergic side effects and stable doses (if the patient does not have a history of depression and major depression in the past two years), estrogen replacement therapy and ginkgo preparations (permissible, but not encouraged); (12) 12 months before aMCI screening, CT or magnetic resonance imaging (MRI) scans showed no evidence of infection, infarction or other focal lesions, and no related clinical symptoms, but allowed lacunar infarction in a non-critical brain region and was not considered to affect the cognitive impairment of the subjects; The score of the Hachinski Ischemia Scale HIS was less than or equal to 4; 2. Control group of normal population: (1) Aged 50-70 years old, Han nationality, right-handed, good health in general, no nervous system diseases; (2) Without complaints and clinical manifestations of memory impairment; (3) normal cognitive function, and the Mini-Mental State Examination scale (MMSE) more than 27 points; (4) The ADL less than 26 points; (5) Without cognitive impairment (clinical dementia scale (CDR) 0). 

排除标准:

遗忘型轻度认知障碍患者 (1)任何引起痴呆的神经系统疾病,包括AD 帕金森病、VaD、亨廷顿病、正常压力脑积水、脑肿瘤、进行性核上性麻痹、癫痫、慢性硬膜下血肿及多发性硬化,有严重头外伤史伴有持续神经功能缺损或已知的脑结构异常。 (2)既往2 年内患抑郁症,汉密尔顿抑郁评定量表得分大于或等于12 分(共17 项,计52分),或符合精神疾病诊断与统计手册(Diagnostic and Statistical Manual of Mental Disorders-Ⅳ。DSM-Ⅳ)诊断标准的其他精神疾病。 (3)既往2 年内有酒精、药物滥用或依赖史(DSM-Ⅳ)。 (4)任何显著的系统性疾病或可能导致难以依从试验设计的不稳定医学情况,包括:①既往5年内有肿瘤病史(转移性皮肤癌除外);②既往有心肌梗死、不稳定或严重心血管疾病史,包括心绞痛或静止状态下有症状的心衰;③临床上显著的阻塞性肺病或哮喘;④临床上显著的和不稳定的胃肠疾病,如胃溃疡或既往2 年内有活动性或隐匿性胃肠道出血病史;⑤临床上一组筛选测验中有显著性的实验室检验异常(血液学、凝血酶原时间、化学、尿检验、心电图);⑥Ⅰ型糖尿病或未控制的糖尿病;⑦未控制的高血压(收缩压大于170mmHg 或舒张压大于100mmHg);⑧既往2年内有临床上显著的肝病、凝血紊乱或维生素K 缺乏病史。 (5)筛选前30d 内使用过药物疗法,包括:①中枢性受体阻滞剂、麻醉药、甲基多巴和可乐定;②抗帕金森病药物,如筛选前2 个月内使用过左旋多巴、金刚烷胺、溴麦角环肽、丙基麦角灵和司来吉兰;③神经镇静药和麻醉性镇痛剂;④苯二氮卓类(地西泮)和巴比妥类药物;⑤短效抗焦虑剂或镇静性睡眠激素的使用每周多于2 次(注意筛选前72h 内不得使用镇静剂);⑥无明显胆碱能副作用的抗抑郁药在剂量改变或起效期;⑦激素;⑧有明显胆碱能或抗胆碱能副作用的药物 (如吡啶斯的明、三环抗抑郁药、氯苯甲嗪、奥昔布宁);⑨抗癫痫药(苯妥英钠、苯巴比妥、卡马西平);⑩华法林(苄丙酮香豆素)。 (6)筛选前30d 内使用过治疗AD 或痴呆的任何临床试验药物,例如维生素补充剂(包括维生素E)、多种维生素、盐酸多奈哌齐、盐酸美金刚以及新近被认可的其他药物疗法。 (7)研究者认为不能依从研究程序的受试者。 

Exclusion criteria:

Patients with amnestic mild cognitive impairment 1. Any neurological disorder that causes dementia, including AD Parkinson's disease, VaD, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, chronic subdural hematoma and multiple sclerosis, with a history of severe head trauma and a history of persistent neurological deficits or known brain structural abnormalities; 2. Depression in the past two years, Hamilton Depression Rating Scale scores more than or equal to 12 points, or other mental disorders that meet the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Diseases; 3. There was a history of alcohol, drug abuse or dependence (DSM-IV) in the past two years; 4. Any significant systemic disease or unstable medical condition that may lead to difficulty in complying with the experimental design, including: (1) a history of cancer in the past five years (excluding metastatic skin cancer); and (2) a history of myocardial infarction, instability or severe cardiovascular disease, including symptomatic heart failure in angina pectoris or resting state; (3) clinically significant obstructive pulmonary disease or asthma; (4) clinically significant and unstable gastrointestinal diseases, such as gastric ulcer or a history of active or occult gastrointestinal bleeding in the past two years; (5) clinically significant laboratory abnormalities in a group of screening tests (hematology, prothrombin time, chemistry, urine test) _Type I diabetes mellitus or uncontrolled diabetes mellitus_uncontrolled hypertension (systolic pressure greater than 170 mmHg or diastolic pressure greater than 100 mmHg); _clinically significant history of liver disease, coagulation disorder or vitamin K deficiency in the past two years; 5. Drug therapy was used within 30 days before joining the study, including: (1) central receptor blockers, anesthetics, methyldopa and clonidine; (2) anti-Parkinson's disease drugs, such as levodopa, amantadine, bromoergic peptide, propylergoline and selegilin, were used within 2 months before screening; (3) neurosedatives and and Analgesics; (4) Benzodiazepines (diazepam) and barbiturates; (5) Short-acting anti-anxiety agents or sedative sleep hormones are used more than twice a week (no sedative should be used within 72 hours before screening); (6) Antidepressants without obvious cholinergic side effects are in dose change or effective period; (7) Hormones; (8) Drugs with obvious cholinergic or anticholinergic side effects (such as pyridostigmine, tricyclic antidepressants, chlorobenzoxazine, oxibnin); (9) Antiepileptic drugs (phenytoin sodium, phenobarbital, carbamazepine); (10) Warfarin (benzylacetone coumarin). 6. Any clinical trial drugs for AD or dementia, such as vitamin supplements (including vitamin E), multivitamins, donepezil hydrochloride, memantine hydrochloride and other recently approved drug therapies, were used within 30 days before the trial; 7. Subjects who the researchers believe cannot follow the research procedure. 

研究实施时间:

Study execute time:

From2018-05-01To 2021-04-30 

干预措施:

Interventions:

组别:

遗忘型轻度认知障碍组

样本量:

30

Group:

Amnestic mild cognitive impairment group

Sample size:

干预措施:

针刺治疗

干预措施代码:

Intervention:

acupuncture treatment

Intervention code:

组别:

正常人群对照组

样本量:

30

Group:

Normal population control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

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):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

广州中医药大学深圳医院(福田) 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

临床痴呆量表

指标类型:

主要指标 

Outcome:

clinical dementia rating

Type:

Primary indicator 

指标中文名:

波士顿命名测验

指标类型:

主要指标 

Outcome:

Boston naming test

Type:

Primary indicator 

指标中文名:

数字颜色连线测验

指标类型:

主要指标 

Outcome:

Digital Color Connection Test

Type:

Primary indicator 

指标中文名:

韦氏记忆量表

指标类型:

主要指标 

Outcome:

Wechsler Memory Scale

Type:

Primary indicator 

指标中文名:

工具性日常生活能力评定

指标类型:

主要指标 

Outcome:

Instrumental daily living ability test

Type:

Primary indicator 

指标中文名:

静息态功能磁共振

指标类型:

主要指标 

Outcome:

resting-state fMRI

Type:

Primary indicator 

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

blood routine examination

Type:

Secondary indicator 

指标中文名:

尿常规

指标类型:

次要指标 

Outcome:

urine routine examination

Type:

Secondary indicator 

指标中文名:

大便常规

指标类型:

次要指标 

Outcome:

stool routine examination

Type:

Secondary indicator 

指标中文名:

肝功能

指标类型:

次要指标 

Outcome:

liver function examination

Type:

Secondary indicator 

指标中文名:

肾功能

指标类型:

次要指标 

Outcome:

kidney function examination

Type:

Secondary indicator 

指标中文名:

心电图

指标类型:

次要指标 

Outcome:

cardiogram

Type:

Secondary indicator 

指标中文名:

简易精神状态检查表

指标类型:

次要指标 

Outcome:

mini-mental state examination

Type:

Secondary indicator 

指标中文名:

老年痴呆症评估量表

指标类型:

次要指标 

Outcome:

Alzheimer Assessment scale

Type:

Secondary indicator 

指标中文名:

海金斯基缺血指数量表

指标类型:

次要指标 

Outcome:

Hachinski ischemic scale

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age 70 years

随机方法(请说明由何人用什么方法产生随机序列):

性别:

男女均可

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

none

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

原始数据及试验结果在试验结束6个月后上传至临床试验公共管理平台(http://www.chictr.org.cn)予以公开、共享。

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

Individual participant data and test results uploaded will be openned and shared to the Research Manager ( ResMan,http://www.chictr.org.cn)after six months for trail ended.

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

一般资料数据采集如实记录在CRF表中,源数据即扫描过程中采集的图像数据通过光盘刻录储存

The repository and management of the data(Please specify what repository will be used for management of the metadata):

The general data will be recorded in case report form (CRF). The original data which gathered during scanning will be reserved in discs.

创建人:

Creater Name:

 2018-12-11
返回列表