ChiCTR2500111952 版本V1.0 版本创建时间2025/11/07 16:17:51 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500111952 

最近更新日期：

Date of Last Refreshed on：

 2025-11-07 16:17:47 

注册时间：

Date of Registration：

 2025-11-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

面向认知功能评测与训练的虚拟现实协同刺激范式研究

Public title：

Research on Virtual Reality Co-stimulation Paradigms for Cognitive Function Assessment and Training

注册题目简写：

English Acronym：

研究课题的正式科学名称：

面向认知功能评测与训练的虚拟现实协同刺激范式研究临床研究方案

Scientific title：

Clinical Research Protocol for a Virtual Reality Co-stimulation Paradigm Targeting Cognitive Function Assessment and Training

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：

尹婷婷 

研究负责人：

柏亚妹 

Applicant：

Yin Tingting 

Study leader：

Bai Yamei 

申请注册联系人电话：

Applicant telephone：

 +86 188 5183 5056

研究负责人电话：

Study leader's
telephone：

+86 195 5199 4118

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：

 yori1998@163.com

研究负责人电子邮件：

Study leader's E-mail：

 czbym@njucm.edu.cn

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：

江苏省南京市栖霞区仙林大道138号

研究负责人通讯地址：

江苏省南京市栖霞区仙林大道138号

Applicant address：

No. 138, Xianlin Avenue, Qixia District, Nanjing City, Jiangsu Province

Study leader's address：

No. 138 Xianlin Avenue, Qixia District, Nanjing City, Jiangsu Province

申请注册联系人邮政编码：

Applicant postcode：

 210046

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

南京中医药大学护理学院

Applicant's institution：

School of Nursing, Nanjing University of Chinese Medicine

研究负责人所在单位：

南京中医药大学护理学院

Affiliation of the Leader：

School of Nursing, Nanjing 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：

 2025NZY-13-01

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：

南京中医药大学伦理委员会

Name of the ethic committee：

Ethics Committee of Nanjing University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-18 00:00:00

伦理委员会联系人：

王均琴

Contact Name of the ethic committee：

Wang Junqin

伦理委员会联系地址：

江苏省南京市栖霞区仙林大道138号

Contact Address of the ethic committee：

No. 138 Xianlin Avenue, Qixia District, Nanjing City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 136 7515 7797

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：

南京中医药大学护理学院

Primary sponsor：

School of Nursing, Nanjing University of Chinese Medicine

研究实施负责（组长）单位地址：

江苏省南京市栖霞区仙林大道138号

Primary sponsor's address：

No. 138 Xianlin Avenue, Qixia District, Nanjing City, Jiangsu Provinc

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

南京

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

南京中医药大学护理学院

具体地址：

江苏省南京市栖霞区仙林大道138号

Institution
hospital：

School of Nursing, Nanjing University of Chinese Medicine

Address：

No. 138 Xianlin Avenue, Qixia District, Nanjing City, Jiangsu Province

经费或物资来源：

经费来源：国家科技部重点研发项目（2023YFC3603602、2023YFC3603605）专项拨款 + 参与医疗机构配套资源物资来源： VR设备：HTC公司无偿借用

Source(s) of funding：

Funding Source: Special allocation from the Key R&D Program of the Ministry of Science and Technology (2023YFC3603602, 2023YFC3603605) + matching resources from participating medical institutions Material Source: VR Equipment: Provided free of charge by HTC Corporation

研究疾病：

轻度认知障碍、主观认知下降  

Target disease：

Mild cognitive impairment, Subjective cognitive decline

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：

随机平行对照 

Study design：

Parallel 

研究目的：

探索基于VR技术的认知训练对认知障碍人群整体认知功能和脑功能的改善和提升作用  

Objectives of Study：

Investigating the Effects of VR-Based Cognitive Training on Improving and Enhancing Overall Cognitive Function and Brain Function in Individuals with Cognitive Impairment

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

MCI人群纳入标准： 1.年龄55-85岁； 2.小学及以上教育程度，视觉及听力无障碍，可配合完成评测； 3.总体认知功能评定：简易精神状态检查量表（MMSE）>=27分且＜29分，临床痴呆评定量表（CDR）=0.5； 4.自愿参加本研究，本人同意并签署知情同意书。 SCD人群纳入标准：入组标准： 1.年龄 55-80岁； 2.小学及以上教育程度，视觉及听力无障碍，可配合完成评测； 3.总体认知功能评定：MoCA>=26分且SCD-Q9>=5分； 4.自愿参加本研究，并签署知情同意书。

Inclusion criteria

Inclusion criteria for MCI population: 1. Age 55-85 years old; 2. Primary school education or above, visual and hearing barrier-free, can cooperate with the completion of the assessment; 3. Overall cognitive function assessment: Mini-Task Mental State Examination Scale (MMSE) >=27 points and <29 points, Clinical Dementia Rating Scale (CDR)=0.5; 4. Voluntarily participate in this study, agree and sign the informed consent form. Inclusion Criteria for SCD Population: Enrollment Criteria: 1. Age 55-80 years old; 2. Primary school education or above, visual and hearing barrier-free, can cooperate with the completion of the assessment; 3. Overall cognitive function assessment: MoCA>=26 points and SCD-Q9>=5 points; 4. Volunteer to participate in this study and sign the informed consent form.

排除标准：

排除标准： 1.具有神经精神疾病病史，如脑血管病、抑郁症、精神分裂症、药物依赖、颅内肿瘤、难治性癫病、帕金森病、正常压力性脑积水、脑部肿瘤及头颅外伤手术等； 2.具有严重影响认知功能的心、肝、肾、造血系统及内分泌系统疾病； 3.头颅磁共振存在梗死病灶、微出血和占位等病灶； 4.正在接受其他非药物干预者。

Exclusion criteria：

Exclusion Criteria: 1. History of neuropsychiatric diseases, such as cerebrovascular disease, depression, schizophrenia, drug dependence, intracranial tumors, refractory epilepsy, Parkinson's disease, normal pressure hydrocephalus, brain tumors and head trauma surgery, etc.; 2. Diseases of the heart, liver, kidney, hematopoietic system and endocrine system that seriously affect cognitive function; 3. Cranial magnetic resonance has infarct lesions, microbleeds and mass occupancy; 4. Those who are receiving other non-pharmacological interventions.

研究实施时间：

Study execute time：

从 From 2024-12-01 00:00:00至 To 2026-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-15 00:00:00 至 To 2026-11-30 00:00:00

干预措施：

Interventions：

组别：

MCI人群：试验组

样本量：

 110

Group：

MCI Population: Experimental Group

Sample size：

干预措施：

头戴式VR康复训练20~30min，每周5次，共计4周。 使用惠普公司的头戴式HP G2 Reverb Omnicept，（目前已上市，得到准入，证书编号：2021010901388500），配有手柄、静态座椅，使用游戏式场景，如VR超市、切水果、打地鼠和记忆水平测试等认知训练任务。同时进行标准照护，所有参加本研究的老年人将接受阶段性的健康教育及生活方式指导，内容包括：调整饮食结构，推荐采用地中海饮食；控制认知减退的危险因素如减少久坐、增加运动及人际交往；注意监测睡眠情况和调整睡眠；关注情绪和如何调整情绪；如何控制高血压、糖尿病、高脂血症等基础病。

干预措施代码：

Intervention：

Head-mounted VR rehabilitation training for 20–30 minutes, 5 times per week, for a total of 4 weeks. The HP G2 Reverb Omnicept headset (currently available on the market, approved for use, certificate number: 2021010901388500) was used, equipped with controllers and a static seat. Game-based scenarios such as VR supermarket, fruit cutting, whack-a-mole, and memory level tests were employed for cognitive training tasks. Concurrent standard care: All elderly participants will receive phased health education and lifestyle guidance covering: dietary adjustments (recommending Mediterranean diet); managing cognitive decline risk factors (reducing sedentary time, increasing physical activity and social engagement); sleep monitoring and adjustment; emotional well-being and coping strategies; and managing underlying conditions like hypertension, diabetes, and hyperlipidemia.

Intervention code：

组别：

MCI人群：对照组

样本量：

 110

Group：

MCI population: control group

Sample size：

干预措施：

进行标准照护4周，每周5次，所有参加本研究的老年人将接受阶段性的健康教育及生活方式指导，内容包括：调整饮食结构，推荐采用地中海饮食；控制认知减退的危险因素如减少久坐、增加运动及人际交往；注意监测睡眠情况和调整睡眠；关注情绪和如何调整情绪；如何控制高血压、糖尿病、高脂血症等基础病。

干预措施代码：

Intervention：

All elderly participants in this study will receive standardized care for 4 weeks, 5 times per week, along with phased health education and lifestyle guidance covering: adjusting dietary patterns with a recommendation for the Mediterranean diet; managing risk factors for cognitive decline such as reducing sedentary behavior, increasing physical activity and social engagement; monitoring and adjusting sleep patterns; addressing emotional well-being and coping strategies; and controlling underlying conditions like hypertension, diabetes, and hyperlipidemia.

Intervention code：

组别：

SCD人群：试验组

样本量：

 110

Group：

SCD population: Experimental group

Sample size：

干预措施：

头戴式VR认知训练20~30min，每周5次，共计4周。 使用惠普公司的头戴式HP G2 Reverb Omnicept，（目前已上市，得到准入，证书编号：2021010901388500），配有手柄、静态座椅，使用游戏式场景，如VR超市购物、切水果、打地鼠和记忆水平测试等认知训练任务。同时进行标准照护，所有参加本研究的老年人将接受阶段性的健康教育及生活方式指导，内容包括：调整饮食结构，推荐采用地中海饮食；控制认知减退的危险因素如减少久坐、增加运动及人际交往；注意监测睡眠情况和调整睡眠；关注情绪和如何调整情绪；如何控制高血压、糖尿病、高脂血症等基础病。

干预措施代码：

Intervention：

Head-mounted VR cognitive training for 20–30 minutes, 5 times per week, for a total of 4 weeks. Utilizing the HP G2 Reverb Omnicept headset (currently available on the market, approved for use, certificate number: 2021010901388500), equipped with controllers and a stationary seat. The training employs game-like scenarios such as VR supermarket shopping, fruit slicing, whack-a-mole, and memory level tests for cognitive tasks. Concurrent standard care: All elderly participants will receive phased health education and lifestyle guidance covering: dietary adjustments (recommending Mediterranean diet); managing cognitive decline risk factors (reducing sedentary time, increasing physical activity and social engagement); sleep monitoring and adjustment; emotional well-being and coping strategies; and managing underlying conditions like hypertension, diabetes, and hyperlipidemia.

Intervention code：

组别：

SCD人群：对照组

样本量：

 110

Group：

SCD population: control group

Sample size：

干预措施：

进行标准照护4周，每周5次，所有参加本研究的老年人给予阶段性的健康教育及生活方式指导，内容包括：调整饮食结构，采用地中海饮食；控制认知减退的危险因素如减少久坐、增加运动及人际交往；注意监测睡眠情况和调整睡眠；关注情绪和如何调整情绪；如何控制高血压、糖尿病、高脂血症等基础病。

干预措施代码：

Intervention：

Standard care was administered for 4 weeks, 5 times per week. All elderly participants in this study received phased health education and lifestyle guidance covering the following areas: adjusting dietary patterns to adopt a Mediterranean diet; controlling risk factors for cognitive decline, such as reducing sedentary behavior, increasing physical activity and social engagement; monitoring and adjusting sleep patterns; managing emotions and learning emotional regulation techniques; and managing underlying conditions like hypertension, diabetes, and hyperlipidemia.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 南京中医药大学 

单位级别：

 大学 

Institution
hospital：

Nanjing University of Chinese Medicine

Level of the institution：

University

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 南京医科大学第一附属医院（江苏省人民医院） 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

MCI：认知功能

指标类型：

主要指标

Outcome：

MCI:Cognitive Function

Type：

Primary indicator

测量时间点：

MCI:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

MCI: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

MCI:日常生活能力，ADL日常生活活动能力量表

指标类型：

主要指标

Outcome：

MCI: Activities of Daily Living (ADL) Scale

Type：

Primary indicator

测量时间点：

MCI:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

MCI: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

MCI:影像学采集

指标类型：

主要指标

Outcome：

MCI: Imaging Acquisition

Type：

Primary indicator

测量时间点：

MCI:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

MCI: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

MCI:生理数据信号采集（脑电数据闭眼状态5min,睁眼状态5min）

指标类型：

主要指标

Outcome：

MCI:Physiological Data Signal Acquisition (EEG data: 5 minutes with eyes closed, 5 minutes with eyes open)

Type：

Primary indicator

测量时间点：

MCI:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

MCI: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

MCI:眼动数据采集（正向眼跳反应时间、反向眼跳反应时间、反向眼跳错误率、眼动轨迹等）

指标类型：

主要指标

Outcome：

MCI:Eye movement data collection (forward saccade reaction time, backward saccade reaction time, backward saccade error rate, eye movement trajectories, etc.)

Type：

Primary indicator

测量时间点：

MCI:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

MCI: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

MCI:功能近红外设备评估

指标类型：

主要指标

Outcome：

MCI:Functional Near-Infrared Device Evaluation

Type：

Primary indicator

测量时间点：

MCI:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

MCI: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

SCD:认知功能

指标类型：

主要指标

Outcome：

SCD: Cognitive Function

Type：

Primary indicator

测量时间点：

SCD:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

SCD: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

SCD:日常生活能力，ADL日常生活活动能力量表

指标类型：

主要指标

Outcome：

SCD: Activities of Daily Living (ADL) Scale

Type：

Primary indicator

测量时间点：

SCD:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

SCD: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

SCD:影像学采集

指标类型：

主要指标

Outcome：

SCD:Imaging Acquisition

Type：

Primary indicator

测量时间点：

SCD:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

SCD: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

SCD:生理数据信号采集（脑电数据闭眼状态5min,睁眼状态5min）

指标类型：

主要指标

Outcome：

SCD:Physiological Data Signal Acquisition (EEG data: 5 minutes with eyes closed, 5 minutes with eyes open)

Type：

Primary indicator

测量时间点：

SCD:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

SCD: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

SCD:眼动数据采集（正向眼跳反应时间、反向眼跳反应时间、反向眼跳错误率、眼动轨迹等）

指标类型：

主要指标

Outcome：

SCD:Eye movement data collection (forward saccade reaction time, backward saccade reaction time, backward saccade error rate, eye movement trajectories, etc.)

Type：

Primary indicator

测量时间点：

SCD:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

SCD: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

指标中文名：

SCD:功能近红外设备评估

指标类型：

主要指标

Outcome：

SCD:Functional Near-Infrared Device Evaluation

Type：

Primary indicator

测量时间点：

SCD:干预之前7天内、干预4周结束后7天内

测量方法：

Measure time point of outcome：

SCD: Within 7 days prior to intervention and within 7 days after completion of the 4-week intervention period

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 55 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）：

在多中心研究中，由本课题组经过统一培训的研究人员使用江苏省人民医院提供的IWRS系统进行受试者随机化分组,能够根据预设的分组算法(如简单随机化或分层随机化)自动将受试者公平地分配到增强现实干预组和常规护理组，同时确保各中心之间的组别平衡，实时记录和同步数据，减少偏倚并提升研究的透明度和效率。

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

In this multicenter study, researchers trained uniformly by our team utilized the IWRS system provided by Jiangsu Provincial People's Hospital to randomize participants. This system automatically and equitably assigns subjects to either the augmented reality intervention group or the standard care group based on predefined randomization algorithms (such as simple randomization or stratified randomization). It simultaneously ensures balanced group distribution across all centers, enables real-time data recording and synchronization, reduces bias, and enhances the transparency and efficiency of the research.

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：

结局评估者盲 评价方法：各组患者在干预前、干预结束（4w）时接受认知和功能评估，评估由同一名接受过专业认知功能评估培训的研究人员在不知道其分组的情况下下完成

Blinding：

Blinded outcome assessors Evaluation method: Patients in each group underwent cognitive and functional assessments before the intervention and at the end of the intervention (4 weeks). The assessments were conducted by the same researcher who had received professional training in cognitive function assessment and who was unaware of the patients' group assignments.

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)：

none

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：

1.本研究的数据类型主要通过CRF表进行收集，必须及时、准确地填写CRF；对于任何缺失/异常数据予以解释。 2.电子采集和管理数据通过医院电子存档系统收集，仅研究者、研究主管部门、伦理委员会将被允许查阅医疗记录。任何有关本项研究结果的公开报告将不会披露个人身份。我们将在法律允许的范围内，尽一切努力保护您个人医疗资料的隐私

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1. The data types in this study are mainly collected through CRF forms, which must be filled out in a timely and accurate manner; any missing/abnormal data must be explained. 2. Electronically collected and managed data are collected through the hospital's electronic archiving system, and only researchers, research authorities, and ethics committees will be allowed to access medical records. Any public reports on the results of this study will not disclose personal identity. We will make every effort to protect the privacy of your personal medical information to the extent permitted by law

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-11-07 16:17:47