针刺治疗遗忘型轻度认知功能障碍(aMCI)的多中心、随机、平行对照预试验

注册号:

Registration number:

AMCTR-IPR-19000306 

注册号获得时间:

Date of releasing the registration number:

2019/10/23 21:38:40 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺治疗遗忘型轻度认知功能障碍(aMCI)的多中心、随机、平行对照预试验 

Public title:

Acupuncture for Amnestic Mild Cognitive Impairment: a Pilot Multi-center, Randomized, Parallel Controlled Trial 

研究课题的正式科学名称:

针刺治疗遗忘型轻度认知功能障碍(aMCI)的多中心、随机、平行对照预试验 

Scientific title:

Acupuncture for Amnestic Mild Cognitive Impairment: a Pilot Multi-center, Randomized, Parallel Controlled Trial 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

张梁 

研究负责人:

张梁 

Applicant:

Zhang Liang 

Study leader:

Zhang Liang 

申请注册联系人电话:

Applicant telephone:

+86 13570937966 

研究负责人电话:

Study leader's telephone:

+86 13570937966 

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:

zhangliang307@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangliang307@foxmail.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:

广州市番禺区广州大学城外环东路232号 

研究负责人通讯地址:

广州市番禺区广州大学城外环东路232号 

Applicant address:

232 Waihuan Road East, Guangzhou University Town, Panyu District, Guangzhou 

Study leader's address:

232 Waihuan Road East, Guangzhou University Town, Panyu District, Guangzhou 

申请注册联系人邮政编码:

Applicant postcode:

510006 

研究负责人邮政编码:

Study leader's postcode:

510006 

申请人所在单位:

广州中医药大学针灸康复临床医学院 

Applicant's institution:

Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine 

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:

ZYYECK[2017]064-XZ-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

广州中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-07 

研究实施负责(组长)单位:

广州中医药大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究实施负责(组长)单位地址:

广州市白云区机场路16号 

Primary sponsor's address:

16 Airport Road, Baiyun 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学针灸康复临床医学院

具体地址:

广州市番禺区广州大学城外环东路232号

Institution
hospital:

Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine

Address:

232 Waihuan Road East, Guangzhou University Town, Panyu District

经费或物资来源:

广州中医药大学“高水平大学建设”项目 

Source(s) of funding:

High-level university construction project of Guangzhou University of Chinese Medicine 

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:

干预性研究 

Study type:

Interventional 

研究所处阶段:

预实验 

Study phase:

Polit 

研究目的:

以针刺疗法治疗遗忘型轻度认知功能障碍(aMCI),与安慰针刺法进行对照研究,作为预试验初步评估针刺治疗aMCI的疗效和安全性,探索针刺治疗aMCI的可行性,为下一阶段开展大样本的临床试验提供参考依据 

Objectives of Study:

A comparative study was conducted between acupuncture therapy for amnesic mild cognitive impairment (aMCI) and placebo acupuncture, which was used as a preliminary trial to evaluate the efficacy and safety of acupuncture therapy for aMCI, and to explore the feasibility of acupuncture therapy for aMCI, so as to provide reference for the next phase of large sample clinical trials 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.符合aMCI诊断标准。 2.老年认知功能减退知情者问卷IQCODE得分≥51分,≤53分。 3.年龄在55岁-70岁,男女均可。 4.具备足够的视觉和听觉分辨力接受神经心理学测试。 5.受试者自愿参加,并签署知情同意书 

Inclusion criteria

1. Meet the diagnostic criteria of aMCI; 2. Informant Questionnaire on Cognitive Decline in the Elderly(IQCODE)scores>=51,<=53分. 3. Aged 55-70 years, male or female; 4. Having sufficient visual and auditory resolution capability to accept neuropsychological testing; 5. Subjects volunteer and sign informed consent file. 

排除标准:

1.受教育程度<6年。 2.汉密尔顿抑郁量表(HAMD)分值≥17分,由抑郁等情绪异常引起的假性痴呆者。 3.先天性智能障碍患者,有痴呆家族史或已诊断为痴呆、精神病及具有其他可引起脑功能障碍的医学或神经心理状态的患者。 4.有脑血管疾病史,包括缺血和出血性脑血管病,神经系统查体有偏瘫、偏身感觉障碍、失语等神经功能障碍体征的患者。 5.具有某些内分泌、遗传、神经系统疾病引起的继发性代谢障碍或因药物诱发的代谢性疾病的患者。 6.危重病人及有其它中枢神经损伤的疾病及病史,如脑外伤、脑炎、癫痫、肿瘤、感染、严重肝肾功能障碍、血液系统疾病、中枢神经系统脱髓鞘疾病与变性疾病等的患者。 7.存在沟通、交流障碍从而影响认知功能评价,如言语、视力、听力等严重障碍的患者。 8.有酗酒、吸毒史,长期应用糖皮质激素、抗精神病类药物、镇静催眠类药物等影响认知功能药物的患者。 9.自诉或家属代诉曾有打鼻鼾症状(不论是否经过系统诊治)者,或曾经PSG检查诊断为睡眠呼吸暂停综合征者。 10.正在参加或近 3个月内参加过其他研究项目者。 11.近1个月内接受过针灸治疗者。 12.对针具或酒精过敏者。 13.梅毒或HIV阳性者。 14.维生素B12、甲状腺功能异常者。 

Exclusion criteria:

1. Educational attainment less than 6 years; 2. Hamilton Depression scale (HAMD) scores >=17 in patients with pseudodementia caused by depression or other emotional disorders; 3. Patients with congenital mental retardation, a family history of dementia, or a diagnosis of dementia, psychosis or other brain dysfunction caused by neuropsychological conditions; 4. Patients with a history of cerebrovascular diseases, including ischemic and hemorrhagic cerebrovascular disease. Patients with signs of neurological dysfunction such as hemiplegia, hemidysesthesia and aphasia in neurological examination; 5. Patients with secondary metabolic disorders caused by certain endocrine, genetic or neurological disorders. Patients with metabolic diseases induced by drugs; 6. Critical patients. Patients with histories of other central nervous system injuries, such as brain trauma, encephalitis, epilepsy, tumor, infection, severe liver and kidney dysfunction, blood disorders, central nervous demyelinative disease and degenerative diseases; 7. Patients with communication disorders that affect cognitive evaluation, such as speech, vision, hearing, and other serious disorders; 8. Patients with a history of alcohol or drug abuse, long term use of glucocorticoid, antipsychotics, sedatives, hypnotics, or other drugs that affect cognitive function; 9. Patients with snore symptoms (whether through systematic treatment or not), or have been diagnosed as sleep apnea syndrome after PSG examination; 10. Those who are participating in or have participated in other research projects in the last three months; 11. Those who have received acupuncture treatment in the past one month; 12. Those who are allergic to needles or alcohol; 13. Those who are positive in syphilis or HIV antibody examination; 14. Patients with vitamin B12 deficiency or thyroid dysfunction. 

研究实施时间:

Study execute time:

From2019-07-01To 2020-06-30 

干预措施:

Interventions:

组别:

针刺组

样本量:

25

Group:

Acupuncture group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

安慰针刺组

样本量:

25

Group:

Placebo acupuncture group

Sample size:

干预措施:

安慰针刺

干预措施代码:

Intervention:

Placebo acupuncture

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):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳宝安区中医院 

单位级别:

Tertiary A 

Institution
hospital:

 

Level of the institution:

 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州市萝岗黄陂医院 

单位级别:

社区医院 

Institution
hospital:

Huangpi Hospital of Luogang District of Guangzhou  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

蒙特利尔认知评估量表

指标类型:

主要指标 

Outcome:

Montreal Cognitive Assessment (MoCA)

Type:

Primary indicator 

指标中文名:

老年痴呆量表(认知部分)

指标类型:

次要指标 

Outcome:

Alzheimer’s Disease Assessment Scale-Cognitive Section (ADAS-cog)

Type:

Secondary indicator 

指标中文名:

延迟故事回忆测试

指标类型:

次要指标 

Outcome:

Delayed Story Recall (DSR)

Type:

Secondary indicator 

指标中文名:

全面衰退量表

指标类型:

次要指标 

Outcome:

Global Deterioration Scale (GDS)

Type:

Secondary indicator 

指标中文名:

事件相关电位P300潜伏期及波幅

指标类型:

次要指标 

Outcome:

Latency and amplitude of Event-Related Potential P300

Type:

Secondary indicator 

指标中文名:

核磁共振成像

指标类型:

次要指标 

Outcome:

Magnetic Resonance Imaging(MRI)

Type:

Secondary indicator 

指标中文名:

血常规

指标类型:

副作用指标 

Outcome:

Blood routine examination

Type:

Adverse events 

指标中文名:

尿常规

指标类型:

副作用指标 

Outcome:

Urine routine examination

Type:

Adverse events 

指标中文名:

肝功能

指标类型:

副作用指标 

Outcome:

Liver function

Type:

Adverse events 

指标中文名:

肾功能

指标类型:

副作用指标 

Outcome:

Kidney function

Type:

Adverse events 

指标中文名:

凝血功能

指标类型:

副作用指标 

Outcome:

Blood coagulation

Type:

Adverse events 

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

Electrocardiograph

Type:

Adverse events 

指标中文名:

梅毒抗体

指标类型:

附加指标 

Outcome:

Antibody of syphilis

Type:

Additional indicator 

指标中文名:

HIV抗体

指标类型:

附加指标 

Outcome:

Antibody of HIV

Type:

Additional indicator 

指标中文名:

维生素B12

指标类型:

附加指标 

Outcome:

Vitamin B12

Type:

Additional indicator 

指标中文名:

电解质

指标类型:

附加指标 

Outcome:

Electrolyte

Type:

Additional indicator 

指标中文名:

指标类型:

Outcome:

Type:

指标中文名:

功能磁共振成像,简易精神状态检查量表

指标类型:

Outcome:

Functional magnetic resonance imaging(fMRI),Mini-mental State Examination (MMSE)

Type:

指标中文名:

日常生活能力量表

指标类型:

次要指标 

Outcome:

Activity of Daily Life( ADL)

Type:

Secondary indicator 

指标中文名:

针刺不良事件发生率

指标类型:

次要指标 

Outcome:

Incidence of acupuncture adverse events

Type:

Secondary indicator 

指标中文名:

按要求完成12周针刺治疗和认知康复训练计划的受试者比例

指标类型:

附加指标 

Outcome:

Proportion of participants who completed the required 12-week acupuncture treatment and cognitive rehabilitation training program

Type:

Additional indicator 

指标中文名:

完成12周有氧运动计划的受试者比例

指标类型:

附加指标 

Outcome:

Proportion of participants who completed a 12-week aerobic exercise program

Type:

Additional indicator 

指标中文名:

治疗过程中的病例脱落率

指标类型:

附加指标 

Outcome:

Rate of drop-out during treatment

Type:

Additional indicator 

指标中文名:

应答率

指标类型:

附加指标 

Outcome:

Response rate

Type:

Additional indicator 

指标中文名:

盲法的检验

指标类型:

附加指标 

Outcome:

Blinding test

Type:

Additional indicator 

指标中文名:

满意度

指标类型:

附加指标 

Outcome:

Satisfaction

Type:

Additional indicator 

指标中文名:

临床痴呆评定量表

指标类型:

次要指标 

Outcome:

Clinical Dementia Rating (CDR)

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 55 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

由华南针灸研究中心采用SAS 9.2的PROC PLAN,完成程序编写和随机化的操作。将随机分配结果通过网络中央随机分配系统发布。通过随机法产生患者顺序号对应的分组结果

性别:

男性

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

The random number sequence is generated by PROC PLAN (SAS 9.2) in South China Research Center for Acupuncture and Moxibustion. The random results are distributed through the network central random distribution system.The grouping results corresponding to patient serial numbers were generated by random method

Gender:

Male

盲法:

单盲

Blinding:

Single blind

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):

2022-06-30之前,使用ResMan平台公布:Http://www.medresman.org

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

Before 2022-06-30, use ResMan database (Http://www.medresman.org)

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):

病例记录表,百奥知数据管理系统

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

CRF and Bioknow System of Data Management

创建人:

Creater Name:

 2019-10-22
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