中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500109093
最近更新日期： Date of Last Refreshed on：	2025-09-11 16:08:48
注册时间： Date of Registration：	2025-09-11 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	帕金森综合征影像人工智能分析核心技术及临床应用研究
Public title：	Research on the core technologies and clinical application of artificial intelligence analysis for images of parkinsonism
注册题目简写：
English Acronym：
研究课题的正式科学名称：	帕金森综合征影像人工智能分析核心技术及临床应用研究
Scientific title：	Research on the core technologies and clinical application of artificial intelligence analysis for images of parkinsonism
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：	吴平	研究负责人：	左传涛
Applicant：	Ping Wu	Study leader：	Chuantao Zuo
申请注册联系人电话： Applicant telephone：	+86 21 64280718	研究负责人电话： Study leader's telephone：	+86 21 64280718
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：	wupingpet@fudan.edu.cn	研究负责人电子邮件： Study leader's E-mail：	6271@huashan.org.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：	上海市徐汇区吴中东路518号	研究负责人通讯地址：	上海市徐汇区吴中东路518号
Applicant address：	No. 518 Wuzhong East Road, Xuhui District, Shanghai	Study leader's address：	No. 518 Wuzhong East Road, Xuhui District, Shanghai
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：	复旦大学附属华山医院
Applicant's institution：	Huashan Hospital, Fudan University
研究负责人所在单位：	复旦大学附属华山医院
Affiliation of the Leader：	Huashan Hospital, Fudan 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：	（2023）临审第（712）号	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：	复旦大学附属华山医院伦理审查委员会
Name of the ethic committee：	Institutional Review Board Huashan Hospital Fudan University
伦理委员会批准日期： Date of approved by ethic committee：	2023-08-18 00:00:00
伦理委员会联系人：	全菁
Contact Name of the ethic committee：	Jing Quan
伦理委员会联系地址：	上海市徐汇区吴中东路518号
Contact Address of the ethic committee：	No. 518 Wuzhong East Road, Xuhui District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 52888921	伦理委员会联系人邮箱： Contact email of the ethic committee：	quanjing1975@163.com

研究实施负责（组长）单位：

复旦大学附属华山医院

Primary sponsor：

Huashan Hospital, Fudan University

研究实施负责（组长）单位地址：

上海市徐汇区吴中东路518号

Primary sponsor's address：

No. 518 Wuzhong East Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属华山医院	具体地址：	上海市徐汇区吴中东路518号
Institution hospital：	Huashan Hospital, Fudan University	Address：	No. 518 Wuzhong East Road, Xuhui District, Shanghai

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Optional topic (self raised)

研究疾病：

帕金森病和非典型帕金森综合征

Target disease：

Parkinson's disease and atypical Parkinsonism

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

连续入组

Study design：

Sequential

研究目的：

1.分别基于脑葡萄糖代谢（FDG）和多巴胺转运体（DAT）正电子发射断层显像（PET）影像进行深度学习，建立稳定的帕金森病（PD）、多系统萎缩（MSA）和进行性核上性麻痹（PSP）的鉴别诊断AI模型，并在纵向临床随访队列中观察模型的鉴别诊断准确率和病情监测价值。 2. 基于上述AI模型，扩展分析小样本病种，如路易小体痴呆（DLB）和皮质基底节变性（CBD）的诊断正确率。 3.在纵向临床随访队列中观察上述AI模型对帕金森综合征临床前驱期，即孤立性快速眼动睡眠期行为障碍（iRBD）患者转归预测的准确性。

Objectives of Study：

1.To establish a stable artificial intelligence (AI) model for the differential diagnosis of Parkinson's disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP) using deep learning based on cerebral glucose metabolism (FDG) and dopamine transporter (DAT) positron emission tomography (PET) images, and to observe the accuracy of the differential diagnosis and the value of disease monitoring of the model in a longitudinal clinical follow-up cohort. 2.To evaluate the diagnostic accuracy when the diseases with smaller sample size, such as dementia with Lewy bodies (DLB) and corticobasal degeneration (CBD), were incorporated to expand the above AI model. 3.To explore the accuracy of the above AI model in predicting the clinical outcome of patients with isolated rapid-eye-movement sleep behavior disorder (iRBD), which is the predromal stage of parkinsonian disorders, in a longitudinal clinical follow-up cohort.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1. 截止2023年8月，受试者在华山医院PET中心完成脑FDG-PET检查和（或）脑DAT-PET检查，并接受至少一次临床回访（华山医院神经内科运动障碍门诊），最终诊断以末次回访为准。
2.年龄20-85岁，性别不限。
3.各疾病组及对照组诊断方法如下： a) PD：满足1988年英国帕金森病脑库标准及2015年国际运动障碍学会制定的PD临床诊断标准，由华山医院神经内科运动障碍专科医师独立诊断为“临床确诊的PD”；b) MSA：满足2008年Neurology杂志发表的Gilman标准，由华山医院神经内科运动障碍专科医师独立诊断为“临床确诊的MSA”；c) PSP：满足2017年国际运动障碍学会制定的PSP临床诊断标准，由华山医院神经内科运动障碍专科医师独立诊断为“临床确诊的PSP”；d) DLB：满足2017年第四届DLB联盟制定的诊断标准，由华山医院神经内科运动障碍专科医师独立诊断为“临床确诊的DLB”；e) CBD：满足2013年制定的CBD临床研究诊断标准，由华山医院神经内科运动障碍专科医师独立诊断为“临床确诊的CBD”；f) iRBD：患者必须经多导睡眠监测系统（Polysomnography, PSG）证实其符合REM睡眠期肌肉失张力消失的诊断标准，并符合下列至少一项：（1）有伤害性的或可能有伤害性的运动症状病史；（2）PSG同步录像记录到患者在REM睡眠期有复杂的运动行为。所有患者在入组时都要接受神经科专家的全面评估，以确保患者没有PD及其叠加综合征或痴呆的证据；g)	非神经变性类帕金森综合征受试者：排除以上PD、MSA、PSP、DLB、CBD诊断、且DAT显像正常的受试者。对诊断存在争议的患者（或者诊断存在变更的患者，即末次临床回访诊断与初始诊断不一致者），由华山医院神经内科运动障碍专业组集体讨论决定。
4.疾病症状及严重程度：疾病组受试者需要具备相应疾病基本诊断特征（如下），疾病严重度不限。a) PD：参照诊断标准中的运动迟缓、肌强直、静止性震颤等症状；b) MSA：参照诊断标准中的自主神经功能障碍、帕金森综合征等症状；c) PSP：参照诊断标准中的眼球活动障碍、平衡障碍、冻结步态、认知和语言损害等症状；d) DLB：参照诊断标准中的波动性认知功能障碍（伴有注意力和警觉性显著变化）、反复出现的视幻觉、RBD、一种或多种帕金森综合征核心症状（运动迟缓、静止性震颤或肌强直）等症状；e) CBD：参照诊断标准中的进行性非对称性肢体僵硬或运动迟缓、肢体肌张力障碍、肢体肌阵挛和口颊部或肢体失用、皮质感觉障碍、异肢现象等症状；f) iRBD：需除外上述全部疾病谱系症状。
5.有影像学同期临床资料（病程，H&Y评分，UPDRS-III评分等）。
6.知情同意：本数据库中所有受试者或其法定代理人均已签署相关数据使用的知情同意。

Inclusion criteria

1. As of August 2023, participants completed brain FDG-PET and/or brain DAT-PET examinations at the Huashan Hospital PET Center and received at least one clinical follow-up (Huashan Hospital Neurology Movement Disorder outpatient clinic), with the final diagnosis based on the last follow-up. 
2. Age 20-85 years, no gender restrictions. 
3. Diagnostic methods for various disease groups and the control group are as follows: a) PD: must meet the UK Parkinson's Disease Brain Bank criteria established in 1988 and the PD clinical diagnostic criteria established by the International Parkinson and Movement Disorder Society in 2015, independently diagnosed by a specialist in movement disorders at Huashan Hospital as 'clinically confirmed PD'; b) MSA: must meet the Gilman criteria published in the journal Neurology in 2008, independently diagnosed by a specialist in movement disorders at Huashan Hospital as 'clinically confirmed MSA'; c) PSP: must meet the PSP clinical diagnostic criteria established by the International Parkinson and Movement Disorder Society in 2017, independently diagnosed by a specialist in movement disorders at Huashan Hospital as 'clinically confirmed PSP'; d) DLB: must meet the diagnostic criteria established by the Fourth DLB Alliance in 2017, independently diagnosed by a specialist in movement disorders at Huashan Hospital as 'clinically confirmed DLB'; e) CBD: must meet the CBD clinical research diagnostic criteria established in 2013, independently diagnosed by a specialist in movement disorders at Huashan Hospital as 'clinically confirmed CBD'; f) iRBD: patients must have their diagnosis of loss of muscle atonia in REM sleep confirmed by polysomnography (PSG) and meet at least one of the following criteria: (1) history of harmful or potentially harmful motor symptoms; (2) PSG synchronized video recordings showing complex motor behaviors during REM sleep. All patients must undergo a comprehensive assessment by a neurology expert upon enrollment to ensure there is no evidence of PD or its overlapping syndromes or dementia; g) Subjects with non-neurodegenerative Parkinsonian syndromes: excluding the above diagnoses of PD, MSA, PSP, DLB, CBD, and with normal DAT imaging. For patients with diagnostic controversies (or those whose diagnosis has changed, i.e., the final clinical follow-up diagnosis differs from the initial diagnosis), the movement disorder professional group at Huashan Hospital will collectively discuss and make a decision. 
4. Disease symptoms and severity: Participants in the disease group must possess the basic diagnostic characteristics of their corresponding disease (as listed below), with no limitations on disease severity. a) PD: refer to symptoms such as bradykinesia, rigidity, and resting tremor in the diagnostic criteria; b) MSA: refer to symptoms of autonomic dysfunction and Parkinsonian syndromes in the diagnostic criteria; c) PSP: refer to symptoms of eye movement disorders, balance disorders, freezing of gait, cognitive and language impairments in the diagnostic criteria; d) DLB: refer to symptoms of fluctuating cognitive impairments (with significant changes in attention and alertness), recurring visual hallucinations, RBD, and one or more core symptoms of Parkinsonian syndromes (bradykinesia, resting tremor, or rigidity) in the diagnostic criteria; e) CBD: refer to symptoms of progressive asymmetric limb rigidity or bradykinesia, limb dystonia, limb myoclonus and oromandibular or limb apraxia, cortical sensory deficits, alien hand phenomenon in the diagnostic criteria; f) iRBD: all symptoms of the aforementioned disease spectrum must be excluded. 
5. There are contemporaneous clinical data from imaging (disease duration, H&Y score, UPDRS-III score, etc.). 
6. Informed consent: All subjects or their legal representatives in this database have signed informed consent regarding the use of relevant data.

排除标准：

1.患者同时存在中风、脑炎、脑外伤或其他中枢神经系统疾病。 2.患者PET图像存在运动伪影等图像不合格情况。

Exclusion criteria：

1.The patient has stroke, encephalitis, brain trauma or other central nervous system diseases. 2.The PET images have nonconformities such as motion artifacts.

研究实施时间：

Study execute time：

从 From 2023-09-01 00:00:00至 To 2027-08-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-09-01 00:00:00 至 To 2025-08-20 00:00:00

干预措施：

Interventions：

组别：	帕金森患者观察组	样本量：	2000
Group：	Parkinson's disease patient observation group	Sample size：	2000
干预措施：	无	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)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属华山医院	单位级别：	三级甲等
Institution hospital：	Huashan Hospital, Fudan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	分类准确性	指标类型：	主要指标
Outcome：	Classification accuracy	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		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	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	20	岁 years
最大 Max age	85	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）：

无

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

None

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：	无
Blinding：	None

是否共享原始数据： IPD sharing	是Yes
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）：	研究结束后，通过ResMan(www.medresman.org.cn)方式共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After the end of the study, it was shared by ResMan (www.medresman.org.cn).
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：	CRF;EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF;EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-09-11 16:08:38