研究疾病:
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主观认知功能减退
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研究疾病代码:
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Target disease:
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subjective cognitive decline
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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本研究以益髓艾炷灸治疗绝经后SCD,观察艾炷灸对患者脑形态结构、脑功能网络连接的影响,探讨“益髓艾炷灸-调节绝经后SCD脑网络/下丘脑-垂体-性腺(HPG)轴-认知改善”效应机理,明确益髓艾炷灸改善绝经后SCD认知功能的脑网络相关机制。
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Objectives of Study:
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This study used Yisui moxa cone moxibustion to treat postmenopausal SCD, observed the effect of moxa cone moxibustion on brain morphological structure and brain functional network connectivity of postmenopausal SCD patients, explored the effect mechanism of "Yisui moxa cone moxibustion regulating brain network / hypothalamus pituitary gonad (HPG) axis cognitive improvement", and clarified the related mechanism of Yisui moxa cone moxibustion improving cognitive function and brain network of postmenopausal SCD patients
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)与 SCD 的诊断标准相符合的患者(2)55~70 岁,右利手; (3)主诉以记忆下降为主要抱怨; (4)以汉语为母语,教育水平 6 年以上,简易智能精神状态量表(MMSE) : 初中及 以上>27分; (5)日常生活活动完好或有非常轻微的损害,社会功能调查表(FAQ)< 9 分; (6)无视觉、听觉或智力缺损,无语言障碍,可顺利回答和填写问卷; (7)近 1 个月未接受过针刺及艾灸治疗,治疗前及整个治疗过程中未服用影响认知的精神类药物。 (8)所有研究对象均获得知情同意,自愿配合并签署知情同意书
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Inclusion criteria
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1. Patients with MCI diagnostic criteria consistent;2.55 to 70 years old, right-handed3The main complaint is about the decline of memory;4Chinese native speaker, education level of more than 6 years, MMSE: junior high school and above > 27 points5the ability of daily life unaffected or slight affected6No visual, auditory or intellectual impairment, no language barrier, can answer and fill in the questionnaire smoothly;7.Without acupuncture and moxibustion treatment for nearly 1 month,No psychotropic drugs affecting cognition were taken before and during treatment8All subjects obtained informed consent, voluntarily cooperated and signed informed consent.
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排除标准:
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(1)MCI、AD 前驱期、痴呆;(2)其他除疑似早期 AD 以外可导致认知下降的神经系统疾病,如帕金森病、血管源性痴呆、脑肿瘤等; (3)有严重心、肝、肾功能不全等全身性疾病者及其他可引起认知下降的系统性疾病,如甲状腺功能异常、贫血、肝性脑病、肾性脑病等;(4)脑异常结构,如智力发育障碍、脑感染、脑梗死、脑出血及有严重头部外伤史或其他累及中枢神经系统疾病,从而影响神经心理学量表评估者;(5)有抑郁、焦虑、双向障碍、精神分裂症等精神疾病病史;(6)在过去 1 年中有物质或药物滥用/成瘾史;(7)近 1 个月曾接受认知功能相关治疗者;(8)严重听力、视力障碍和失语导致不能实现评估和不能完成试验者;(9)体内有金属残留等对磁共振扫描有影响而无法进行核磁共振检查者;(10)任何其他不确定状况所致不能完成该项目者。
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Exclusion criteria:
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(1) MCI, AD prodrome, dementia;(2) Other neurological diseases that can lead to cognitive decline, except for suspected early AD, such as Parkinson's disease, vascular-derived dementia, and brain tumors;(3) Patients with severe systemic diseases such as heart, liver and renal insufficiency and other systemic diseases that can cause cognitive decline, such as thyroid dysfunction, anemia, hepatic encephalopathy, renal encephalopathy, etc.;(4) Abnormal brain structure, such as intellectual development disorder, brain infection, cerebral infarction, cerebral hemorrhage and a history of severe head trauma or other diseases involving the central nervous system, thus affecting the neuropsychological scale assessment;(5) A history of depression, anxiety, bidirectional disorder, schizophrenia and other mental disorders;(6) History of substance or substance abuse / addiction in the past 1 year;(7) Those who have received cognitive function-related treatment in the past 1 month;(8) Severe hearing, visual impairment and aphasia who are unable to evaluate or complete the test;, (9) those with metal residues in the body and unable to perform MRI examination;(10) Failure to complete the project due to any other uncertain situation.
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研究实施时间:
Study execute time:
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从From
2022-06-30
至To
2025-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-06-30
至To
2025-12-31
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