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脑卒中后嗅觉功能与认知功能的关系及嗅觉中枢神经调控对卒中后认知障碍疗效的研究
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注册号：

Registration number：

 ChiCTR2500106744 

最近更新日期：

Date of Last Refreshed on：

 2025-07-29 15:47:49 

注册时间：

Date of Registration：

 2025-07-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

脑卒中后嗅觉功能与认知功能的关系及嗅觉中枢神经调控对卒中后认知障碍疗效的研究

Public title：

Investigation on the Association Between Olfactory Function and Cognitive Impairment After Stroke and Therapeutic Efficacy of Central Olfactory Neuromodulation for Post-Stroke Cognitive Impairment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

脑卒中后嗅觉功能与认知功能的关系及嗅觉中枢神经调控对卒中后认知障碍疗效的研究

Scientific title：

Investigation on the Association Between Olfactory Function and Cognitive Impairment After Stroke and Therapeutic Efficacy of Central Olfactory Neuromodulation for Post-Stroke Cognitive Impairment

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：

孙丽 

研究负责人：

王培 

Applicant：

Li Sun 

Study leader：

Pei Wang 

申请注册联系人电话：

Applicant telephone：

 +86 139 5130 1540

研究负责人电话：

Study leader's
telephone：

+86 159 5175 2352

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：

 Lilysunntfy@163.com

研究负责人电子邮件：

Study leader's E-mail：

 wangpei0717@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：

南京市鼓楼区新模范马路3号

研究负责人通讯地址：

南京市鼓楼区新模范马路3号

Applicant address：

3 New Model Road, Gulou District, Nanjing

Study leader's address：

3 New Model Road, Gulou District, Nanjing

申请注册联系人邮政编码：

Applicant postcode：

 210003

研究负责人邮政编码：

Study leader's postcode：

 210003

申请人所在单位：

东南大学附属中大医院

Applicant's institution：

Zhongda Hospital of Southeast University

研究负责人所在单位：

东南大学附属中大医院

Affiliation of the Leader：

Zhongda Hospital of Southeast 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：

 2025ZDSYLL186-P01

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：

东南大学附属中大医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of Zhongda Hospital, Southeast University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-30 00:00:00

伦理委员会联系人：

王慧萍

Contact Name of the ethic committee：

Huiping Wang

伦理委员会联系地址：

南京市鼓楼区丁家桥87号

Contact Address of the ethic committee：

No. 87, Dingjiaqiao, Gulou District, Nanjing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 25 8327 2015

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：

东南大学附属中大医院

Primary sponsor：

Zhongda Hospital of Southeast University

研究实施负责（组长）单位地址：

南京市鼓楼区新模范马路3号

Primary sponsor's address：

3 New Model Road, Gulou District, Nanjing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu province

City：

单位(医院)：

东南大学附属中大医院

具体地址：

南京市鼓楼区新模范马路3号

Institution
hospital：

Zhongda Hospital of Southeast University

Address：

3 New Model Road, Gulou District, Nanjing

经费或物资来源：

课题经费

Source(s) of funding：

Subject funding

研究疾病：

脑卒中  

Target disease：

Stroke

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1、本研究通过评估卒中患者与健康对照组的认知及嗅觉功能，探讨嗅觉功能与卒中后认知功能之间的相关性。 2、通过在卒中后认知障碍患者中实施嗅觉训练及调控嗅觉中枢神经，探索嗅觉训练及嗅觉中枢神经调控对卒中后认知功能及嗅觉功能的潜在效果及作用机制。 3、采用rs-fMRI技术，揭示嗅觉功能与卒中后认知功能之间的潜在神经机制。  

Objectives of Study：

1.This study evaluated the cognitive and olfactory functions of stroke patients and healthy control subjects to explore the correlation between olfactory function and post-stroke cognitive function. 2.By implementing olfactory training and central olfactory neuromodulation in patients with post-stroke cognitive impairment, we aim to explore the potential effects and mechanisms of olfactory training and central olfactory neuromodulation on post-stroke cognitive function and olfactory function. 3.Using the rs-fMRI technique to reveal the potential neural mechanisms underlying the relationship between olfactory function and cognitive function after stroke.

药物成份或治疗方案详述：

无 

Description for medicine or protocol of treatment in detail：

None 

纳入标准：

Inclusion criteria

排除标准：

研究1：①发病前合并发生了其他可能影响认知功能及嗅觉功能的神经精神疾病，如阿尔兹海默病、帕金森氏病、颅脑外伤、精神分裂症等；②有鼻腔或鼻窦疾病或手术史、阻塞性肺部疾病、3周内患过感冒；③存在MRI检查禁忌证（安装心脏起搏器、体内金属置入、幽闭恐惧症等）；④有癫痫病史及使用致痫药物。 研究2：①发病前合并发生了其他可能影响认知功能及嗅觉功能的神经精神疾病，如阿尔兹海默病、帕金森氏病、颅脑外伤、精神分裂症等；②有鼻腔或鼻窦疾病或手术史、阻塞性肺部疾病、3周内患过感冒；③有玫瑰、桉树、柠檬或丁香气味过敏史；④存在MRI检查禁忌证（安装心脏起搏器、体内金属置入、幽闭恐惧症等）；⑤有癫痫病史及使用致痫药物。 研究3：①发病前合并发生了其他可能影响认知功能及嗅觉功能的神经精神疾病，如阿尔兹海默病、帕金森氏病、颅脑外伤、精神分裂症等；②有鼻腔或鼻窦疾病或手术史、阻塞性肺部疾病、3周内患过感冒；③有颅骨缺损；④有电休克治疗史；⑤存在MRI检查禁忌证（安装心脏起搏器、体内金属置入、幽闭恐惧症等）；⑥有癫痫病史及使用致痫药物。

Exclusion criteria：

Experiment 1: 1 Before the onset of the disease, other neurological and psychiatric disorders that might affect cognitive function and olfactory function occurred, such as Alzheimer's disease, Parkinson's disease, brain trauma, schizophrenia, etc. 2 There is a history of nasal or sinus diseases or surgeries, obstructive pulmonary diseases, or having caught a cold within 3 weeks. 3 There are contraindications for MRI examination (such as having a pacemaker implanted, having metal implants in the body, having claustrophobia, etc.). 4 There is a history of epilepsy and the use of anticonvulsant drugs. Experiment 2: 1) Before the onset of the disease, other neurological and psychiatric disorders that might affect cognitive function and olfactory function occurred, such as Alzheimer's disease, Parkinson's disease, brain trauma, schizophrenia, etc. 2) There is a history of nasal or sinus diseases or surgeries, obstructive pulmonary diseases, or having caught a cold within 3 weeks. 3) There is a history of allergic reactions to rose, eucalyptus, lemon or cinnamon odors. 4) There are contraindications for MRI examination (such as having a pacemaker installed, having metal implants in the body, having claustrophobia, etc.). 5) There is a history of epilepsy and the use of anticonvulsant drugs. Experiment 3: 1) Before the onset of the disease, other possible neurological and psychiatric disorders that could affect cognitive function and olfactory function occurred, such as Alzheimer's disease, Parkinson's disease, brain trauma, schizophrenia, etc. 2) There is a history of nasal or sinus diseases or surgeries, obstructive pulmonary diseases, or having caught a cold within 3 weeks. 3) There is a cranial bone defect. 4) There is a history of electroconvulsive therapy. 5) There are contraindications for MRI examination (such as having a pacemaker implanted, having metal implants inside the body, having claustrophobia, etc.). 6) There is a history of epilepsy and the use of anticonvulsant drugs.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

研究1：脑卒中组

样本量：

 80

Group：

Experiment 2:Stroke Patient group

Sample size：

干预措施：

对所有受试者进行 MoCA 、MMSE、Sniffin’Sticks 嗅觉测试及 rs-fMRI 扫描。

干预措施代码：

 1

Intervention：

All the subjects were subjected to the MoCA, MMSE, Sniffin' Sticks olfactory test and rs-fMRI scans.

Intervention code：

组别：

研究1：健康受试组

样本量：

 40

Group：

Experiment 1:Healthy Control group

Sample size：

干预措施：

对所有受试者进行 MoCA 、MMSE、Sniffin’Sticks 嗅觉测试及 rs-fMRI 扫描。

干预措施代码：

 1

Intervention：

All the subjects were subjected to the MoCA, MMSE, Sniffin' Sticks olfactory test and rs-fMRI scans.

Intervention code：

组别：

研究2：观察组

样本量：

 14

Group：

Experiment 2:Olfactory Training group

Sample size：

干预措施：

使用苯乙醇（玫瑰）、桉叶醇（桉树）、香茅醛（柠檬）、丁香酚（丁香）4种气味，每种气味嗅10s左右，两种嗅剂间隔10s。每次训练时长5min，每天早餐前及晚睡前各训练1次，连续治疗3月。

干预措施代码：

 2

Intervention：

Using four odors: phenylethanol (rose), eucalyptol (eucalyptus), citronellal (lemon), and eugenol (clove), each odor was smelled for about 10 seconds. The two odors were separated by 10 seconds. Each training session lasted for 5 minutes. It was conducted once before breakfast and once before bedtime every day, for a total of 3 months of continuous treatment.

Intervention code：

组别：

研究2：对照组

样本量：

 14

Group：

Experiment 2:control group

Sample size：

干预措施：

采用常规认知康复训练，由经过专业训练、具备资质的认知治疗师进行场常规认知训练，包括记忆力、注意力、执行能力及视空间能力训练等，30min/次，每天一次。患者由医院回归家庭后，即在认知治疗师指导下行家庭认知训练。

干预措施代码：

 3

Intervention：

Conventional cognitive rehabilitation training is adopted. Professional and qualified cognitive therapists conduct regular cognitive training for the patients, including memory, attention, executive ability, and visuospatial ability training, etc. Each session lasts for 30 minutes and is conducted once a day. After the patients return home from the hospital, they will carry out family cognitive training under the guidance of the cognitive therapists.

Intervention code：

组别：

研究3：TI组

样本量：

 14

Group：

Experiment 3:TI group

Sample size：

干预措施：

采用美国Soterix Medical Inc生产的频差干涉无创深部脑刺激系统，型号：0113S。刺激方案（即电流强度和电极位置）是通过使用SimNIBS框架构建头部模型来确定的，电极位置和电流大小：O1 0.95mA；PO9 -0.95mA；Ex 13 1.05mA；Ex18 1 -1.05mA。频率分别为1300赫兹和1430赫兹，从而产生干扰电场频率130赫兹。总刺激持续时间为20min，包括开始时的30秒电流上升和结束时的30秒下降。每天治疗一次，连续治疗10d。

干预措施代码：

 4

Intervention：

The non-invasive deep brain stimulation system with frequency difference interference technology, produced by Soterix Medical Inc of the United States, model: 0113S, was adopted. The stimulation protocol (i.e., current intensity and electrode position) was determined by constructing a head model using the SimNIBS framework. The electrode positions and current magnitudes were as follows: O1 0.95mA; PO9 -0.95mA; Ex 13 1.05mA; Ex18 -1.05mA. The frequencies were 1300 Hz and 1430 Hz respectively, thereby generating an interference electric field frequency of 130 Hz. The total stimulation duration was 20 minutes, including a 30-second current rise at the beginning and a 30-second current drop at the end. The treatment was administered once a day for 10 consecutive days.

Intervention code：

组别：

研究3：tDCS组

样本量：

 14

Group：

Experiment 3:tDCS group

Sample size：

干预措施：

采用南京沃高医疗科技有限公司生产的A620P经颅电刺激仪，将直径为5厘米的阳极圆形盐水电极片置于患者左侧眶额皮层区（FP1区），阴极圆形盐水电极片置于对侧肩部。选择直流电刺激模式，电流强度为2毫安，每次治疗时长为20min，每天治疗一次，连续治疗10d。

干预措施代码：

 5

Intervention：

The A620P transcranial electrical stimulation device produced by Nanjing Wao Gao Medical Technology Co., Ltd. was used. A circular salt water electrode sheet with a diameter of 5 centimeters was placed on the left orbitofrontal cortex area (FP1 area) of the patient, while a circular salt water electrode sheet with a negative polarity was placed on the opposite shoulder. The direct current stimulation mode was selected, with an intensity of 2 milliamperes. Each treatment lasted for 20 minutes, and it was performed once a day for 10 consecutive day.

Intervention code：

组别：

研究3：对照组

样本量：

 14

Group：

Experiment 3:control group

Sample size：

干预措施：

采用 TI 组的模拟刺激模式，模拟刺激只有在刺激开始和结束时分别有 30 秒的电流上升和下降，以模拟实际刺激的感觉。

干预措施代码：

 6

Intervention：

Using the TI group's sham stimulation mode, the sham stimulation only has a 30-second current rise and fall at the beginning and end of the stimulation, respectively, to simulate the sensation of the actual stimulation.

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 province

City：

单位(医院)：

 东南大学附属中大医院 

单位级别：

 三甲医院 

Institution
hospital：

zhongda hospital of southeast university

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

测量时间点：

干预之前与干预之后

测量方法：

量表测量

Measure time point of outcome：

Before and after intervention

Measure method：

Scale measuremen

指标中文名：

简易智能状态检查量表

指标类型：

次要指标

Outcome：

mini-mental state examination,MMSE

Type：

Secondary indicator

测量时间点：

干预之前与干预之后

测量方法：

量表测量

Measure time point of outcome：

Before and after intervention

Measure method：

Scale measuremen

指标中文名：

嗅觉功能——Sniffin’Sticks嗅觉测试

指标类型：

主要指标

Outcome：

Sniffin’Sticks

Type：

Primary indicator

测量时间点：

干预之前与干预之后

测量方法：

气味刺激

Measure time point of outcome：

Before and after intervention

Measure method：

odor stimulation

指标中文名：

静息态功能核磁共振

指标类型：

主要指标

Outcome：

rs-fMRI

Type：

Primary indicator

测量时间点：

干预之前与干预之后

测量方法：

磁共振机器扫描

Measure time point of outcome：

Before and after intervention

Measure method：

Magnetic resonance machine scanning

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

 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 25 岁 years
最大 Max age 75 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）：

研究1：为个人联系受试者，不涉及随机化方法。 研究2和研究3：在招募研究参与者之前，我们将建立一个随机化分组表，表中的编号将与实验参与者一一对应。符合标准的参加者将被（按1:1的基础）随机分配至各个实验组。随机分配的过程将由独立于研究团队的第三方实施，以确保随机性的可靠性。

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

Experiment 1:To contact the subjects individually, without using any randomization methods. Experiment 2 and Experiment 3:Before recruiting the research participants, we will establish a randomization grouping table, in which the numbers will correspond one-to-one with the experimental participants. Participants who meet the criteria will be randomly assigned (on a 1:1 basis) to each experimental group. The random allocation process will be carried out by a third party independent of the research team to ensure the reliability of randomness.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

研究1不涉及盲法。 研究2和研究3由于研究的干预性质，在实验中不可能对操作神经调控仪器的治疗师及参与者使用盲法，但该治疗师将不会参与评估环节。另外，参与评估与统计分析的研究人员将不参与参与者的筛选和分配。所有结果数据将由进行随机分组的人员(独立于研究小组)使用唯一编号和小组代码(第1组和第2组)收集和输入。

Blinding：

The blind method was not involved in experiment 1. In experiment 2 and experiment 3, because of the intervention nature of the study, it is impossible to use blind method to the therapists operating the neuro-regulation equipment and the participants during the experiments. However, this therapist will not be involved in the evaluation process.. In addition, researchers involved in evaluation and statistical analysis will not participate in the screening and distribution of participants. All result data will be collected and entered by randomly grouped personnel (independent of the research team) using unique numbers and team codes (groups 1 and 2).

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

国家生物信息中心 https://ngdc.cncb.ac.cn/gsub/

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

China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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：

数据采集与管理将结合病例记录表与电子采集和管理系统进行

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

Data collection and management will be combined with case record forms and electronic collection and management systems

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：

  2025-07-29 15:47:40
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