ChiCTR2600118477 版本V1.0 版本创建时间2026/02/06 09:45:56 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：

ChiCTR2600118477 

最近更新日期：

Date of Last Refreshed on：

2026-02-06 09:45:48 

注册时间：

Date of Registration：

2026-02-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于可穿戴设备分析重复经颅磁刺激治疗帕金森病步态障碍的临床疗效研究

Public title：

Clinical efficacy study of repetitive transcranial magnetic stimulation in treating gait disorders of Parkinson's disease based on wearable device analysis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于可穿戴设备分析重复经颅磁刺激治疗帕金森病步态障碍的临床疗效研究

Scientific title：

Clinical efficacy study of repetitive transcranial magnetic stimulation in treating gait disorders of Parkinson's disease based on wearable device analysis

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：

熊文楠 

研究负责人：

杨兴隆 

Applicant：

Xiong Wennan 

Study leader：

Yang Xinglong 

申请注册联系人电话：

Applicant telephone：

+86 183 8868 1915

研究负责人电话：

Study leader's telephone：

+86 159 6941 0018

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：

18388681915@163.com

研究负责人电子邮件：

Study leader's E-mail：

yxldoc11@163.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：

云南省昆明市五华区西昌路295号

研究负责人通讯地址：

云南省昆明市五华区西昌路295号

Applicant address：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province

Study leader's address：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province

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：

昆明医科大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Kunming Medical University

研究负责人所在单位：

昆明医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Kunming Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2026)伦理L第27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：

昆明医科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 Kunming Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-17 00:00:00

伦理委员会联系人：

张晓雨

Contact Name of the ethic committee：

Zhang xiaoyu

伦理委员会联系地址：

云南省昆明市五华区西昌路295号

Contact Address of the ethic committee：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 184 8755 0319

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：

昆明医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Kunming Medical University

研究实施负责（组长）单位地址：

云南省昆明市五华区西昌路295号

Primary sponsor's address：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

云南省

市(区县)：

昆明市

Country：

China

Province：

Yunnan

City：

Kunming

单位(医院)：

昆明医科大学第一附属医院

具体地址：

云南省昆明市五华区西昌路295号

Institution
hospital：

The First Affiliated Hospital of Kunming Medical University

Address：

No. 295, Xichang Road, Wuhua District, Kunming City, Yunnan Province

经费或物资来源：

昆医大附一院535高层次人才（学科带头人）

Source(s) of funding：

The 535 High-level Talent (Discipline Leader) of the First Affiliated Hospital of Kunming Medical University

Target disease：

Parkinson's disease

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）通过可穿戴设备采集的客观、动态日常步态数据（如步速、步长、冻结步态发作频率等），系统验证重复经颅磁刺激（rTMS）对帕金森病（PD）步态障碍的临床疗效，明确rTMS对不同类型PD步态障碍（如步速减慢、冻结步态）的改善程度与稳定性。 2）评估可穿戴设备在rTMS治疗PD步态障碍疗效监测中的有效性与实用性，验证其采集的客观指标与传统主观量表（如UPDRS-III步态评分）、实验室静态指标的一致性，为疗效评估提供“生活化”量化工具。 3）探索rTMS治疗PD步态障碍的潜在影响因素（如患者病程、步态障碍严重程度），明确其适用人群特征，为优化PD步态障碍的非药物治疗方案、推动精准治疗提供循证依据。  

Objectives of Study：

1) By collecting objective and dynamic daily gait data (such as walking speed, step length, frequency of freezing gait episodes, etc.) through wearable devices, the system verifies the clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) on gait disorders in Parkinson's disease (PD), and clarifies the degree and stability of rTMS's improvement on different types of PD gait disorders (such as slowed walking speed, freezing gait). 2) Evaluate the effectiveness and practicality of wearable devices in monitoring the therapeutic efficacy of rTMS for PD gait disorders, verify the consistency of the objective indicators collected by the devices with traditional subjective scales (such as UPDRS-III gait score) and laboratory static indicators, and provide "real-life" quantitative tools for efficacy assessment. 3) Explore potential influencing factors of rTMS in treating PD gait disorders (such as patient's disease duration, severity of gait disorder), clarify the characteristics of applicable populations, and provide evidence-based basis for optimizing non-pharmacological treatment plans for PD gait disorders and promoting precise treatment.

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.?符合国际运动障碍协会（MDS）2015年修订的PD诊断标准，处于Hoehn-Yahr（H-Y）分期2-3期。 2.存在明确步态障碍，采用统一帕金森病评定量表（UPDRS）Ⅲ中“步态”条目评分≥2分，或简易步态分析量表（SGA）评分≥3分。 3.年龄40-85岁，性别不限，能够配合完成rTMS治疗及可穿戴设备数据采集。 4.自愿签署知情同意书，经医院伦理委员会审批通过。

Inclusion criteria

1. It meets the revised diagnostic criteria for Parkinson's disease (PD) by the International Parkinson and Movement Disorder Society (MDS) in 2015, and is at Hoehn-Yahr (H-Y) stage 2-3. 2. There is a clear gait disorder, with a score of >= 2 points in the "gait" item of the Unified Parkinson's Disease Rating Scale (UPDRS) III, or a score of >= 3 points in the Simple Gait Analysis Scale (SGA). 3. The age ranges from 40 to 85 years old, with no gender restrictions, and is able to cooperate with rTMS treatment and data collection by wearable devices. 4. Voluntary signing of the informed consent form and approval by the hospital's ethics committee.

排除标准：

1.存在rTMS治疗禁忌证，如颅内金属植入物（除人工耳蜗外）、癫痫病史、严重脑外伤或脑卒中后遗症、精神疾病（如抑郁量表评分≥17分）。 2.合并严重心肺功能障碍、肝肾功能不全、恶性肿瘤等全身性疾病，无法耐受治疗及随访。 3.步态障碍由其他疾病导致（如腰椎管狭窄、关节炎、小脑病变），而非PD本身引起。 4.无法配合可穿戴设备佩戴（如皮肤过敏、肢体活动严重受限）或存在认知障碍（蒙特利尔认知评估量表MoCA＜26分）。

Exclusion criteria：

1. There are contraindications for rTMS treatment, such as intracranial metallic implants (except for cochlear implants), a history of epilepsy, severe brain trauma or sequelae of stroke, and mental disorders (such as a depression score of ≥17 on the depression scale). 2. Patients with severe cardiopulmonary dysfunction, liver or kidney failure, or systemic diseases such as malignant tumors cannot tolerate the treatment and follow-up. 3. Gait disorders are caused by other diseases (such as lumbar spinal stenosis, arthritis, cerebellar lesions), rather than being caused by PD itself. 4. They cannot wear wearable devices (such as skin allergies, severe limitations in limb movement) or have cognitive impairments (Montreal Cognitive Assessment Scale MoCA score

研究实施时间：

Study execute time：

从 From 2026-01-20 00:00:00至 To 2027-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-20 00:00:00 至 To 2027-05-01 00:00:00  

干预措施：

Interventions：

组别：

M1组

样本量：

20

Group：

Group M1

Sample size：

干预措施：

行M1区重复经颅磁刺激治疗

干预措施代码：

Intervention：

Repetitive transcranial magnetic stimulation treatment in area M1

Intervention code：

组别：

PPC组

样本量：

20

Group：

Group PPC

Sample size：

干预措施：

行PPC区重复经颅磁刺激治疗

干预措施代码：

Intervention：

Repetitive transcranial magnetic stimulation treatment in area PPC

Intervention code：

组别：

M1+PPC组

样本量：

20

Group：

Group M1+PPC

Sample size：

干预措施：

行M1+PPC区重复经颅磁刺激治疗

干预措施代码：

Intervention：

Repetitive transcranial magnetic stimulation treatment in area M1+PPC

Intervention code：

组别：

假刺激组

样本量：

20

Group：

The sham stimulation group

Sample size：

干预措施：

行假刺激治疗

干预措施代码：

Intervention：

Fake stimulus action

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南 

市(区县)：

 昆明 

Country：

China 

Province：

Yunnan 

City：

Kunming 

单位(医院)：

昆明医科大学第一附属医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Kunming Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

步态

指标类型：

主要指标

Outcome：

Gait

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：

N/A

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 40 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）：

PASS 软件随机分组

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

PASS Software Random Grouping

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

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）：

论文发表后半年内，国家生物信息中心https://www.cncb.ac.cn/。

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

Within six months after the paper is published, the National Center for Bioinformation https://www.cncb.ac.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：

本研究数据采集与管理按以下规范实施：入组基线阶段，采集受试者人口学、帕金森病病程及用药史，通过可穿戴设备（加速度计）获取步速、步长等步态核心指标，同步完成UPDRS-III步态评分、Berg平衡量表评估并记录重复经颅磁刺激刺激参数；干预期间，每次治疗前核对设备参数，可穿戴设备每日1次、每次≥10min平地行走步态连续监测，每周详实记录头痛、头晕等不良反应；干预结束（如4周）及随访（如8周）时，重复基线步态指标与量表评估，导出设备原始数据并双人核对记录，所有采集工作由经统一培训的神经内科医生与康复治疗师执行。数据管理方面，采用Excel或EPIDATA搭建电子化数据库，为每位受试者分配唯一ID，字段涵盖采集时间、指标数据、操作者等信息并设置逻辑校验规则；实行双录入核查机制，2名数据员独立录入后软件比对差异，第三方复核纠错，原始量表与设备数据同步纸质存档及电子扫描备份；每周抽查10%病例核对设备原始数据与录入数据，对分组信息实施盲法管理，评估者双盲评分减少偏倚；数据库加密存储，权限分级管控，研究者仅查看本人负责数据，数据采用本地+云端定期备份，研究结束后按规范归档，全程保障数据安全与受试者隐私。

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

The data collection and management for this study were carried out in accordance with the following guidelines: During the baseline stage of enrollment, demographic information, duration of Parkinson's disease, and medication history of the subjects were collected. Core gait indicators such as walking speed and step length were obtained through wearable devices (accelerometers). The UPDRS-III gait score, Berg Balance Scale assessment, and stimulation parameters of repetitive transcranial magnetic stimulation were completed simultaneously and recorded. During the intervention period, the device parameters were checked before each treatment. The wearable device continuously monitored the gait of 10-minute flat-ground walking once a day, and detailed adverse reactions such as headache and dizziness were recorded weekly. At the end of the intervention (e.g., 4 weeks) and during follow-up (e.g., 8 weeks), the baseline gait indicators and scale assessments were repeated. The original data from the devices were exported and double-checked by two individuals. All data collection work was carried out by neurologists and rehabilitation therapists who had received unified training. In terms of data management, an electronic database was established using Excel or EPIDATA. A unique ID was assigned to each subject, and fields included information such as collection time, indicator data, and operators, and logical verification rules were set. A double-entry verification mechanism was implemented, where two data clerks independently entered the data and the software compared the differences. A third party reviewed and corrected the errors. The original scales and device data were simultaneously archived in paper form and electronically scanned for backup. 10% of cases were randomly selected for checking the original data from the devices and the entered data every week. The grouping information was managed in a blinded manner to reduce bias. The data were encrypted and stored with hierarchical access control. The researchers only viewed the data they were responsible for. The data were regularly backed up locally and in the cloud, and the study was archived according to the guidelines after the conclusion of the study. The entire process ensured data security and the privacy of the subjects.

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：

  2026-02-06 09:45:48