ChiCTR2600123301 版本V1.0 版本创建时间2026/04/23 17:10:58 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：

ChiCTR2600123301 

最近更新日期：

Date of Last Refreshed on：

2026-04-23 17:09:21 

注册时间：

Date of Registration：

2026-04-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项腕部佩戴低频治疗仪经皮传入模式治疗中重度震颤患者手部震颤的有效性与安全性的随机、双盲、假刺激对照研究

Public title：

A randomized double-blind sham-stimulation controlled study on the efficacy and safety of transcutaneous afferent patterned stimulation therapy through wrist-worn device for adult patients with modest to severe tremor

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项腕部佩戴低频治疗仪经皮传入模式治疗中重度震颤患者手部震颤的有效性与安全性的随机、双盲、假刺激对照研究

Scientific title：

A randomized double-blind sham-stimulation controlled study on the efficacy and safety of transcutaneous afferent patterned stimulation therapy through wrist-worn device for adult patients with modest to severe tremor

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：

王钦 

研究负责人：

王钦 

Applicant：

Wang Qin 

Study leader：

Wang Qin 

申请注册联系人电话：

Applicant telephone：

+86 139 1835 9398

研究负责人电话：

Study leader's telephone：

+86 139 1835 9398

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：

wang.qin@zs-hospital.sh.cn

研究负责人电子邮件：

Study leader's E-mail：

wang.qin@zs-hospital.sh.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：

上海徐汇区枫林路180号

研究负责人通讯地址：

上海徐汇区枫林路180号

Applicant address：

No 180 Fenglin Road, XuHui District, Shanghai

Study leader's address：

No 180 Fenglin 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：

复旦大学附属中山医院

Applicant's institution：

Zhongshan hospital Fudan University

研究负责人所在单位：

复旦大学附属中山医院

Affiliation of the Leader：

Zhongshan hospital Fudan 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：

B2026-050R

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：

复旦大学附属中山医院医学伦理委员会

Name of the ethic committee：

Zhongshan Hospital Ethic Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2026-02-25 00:00:00

伦理委员会联系人：

杨梦婕

Contact Name of the ethic committee：

Yang Mengjie

伦理委员会联系地址：

上海市徐汇区枫林路180号

Contact Address of the ethic committee：

No 180 Fenglin Road, XuHui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 3158 7851

伦理委员会联系人邮箱：

Contact email of the ethic committee：

ec@zs-hospital.sh.cn

研究实施负责（组长）单位：

复旦大学附属中山医院

Primary sponsor：

Zhongshan Hospital Fudan University

研究实施负责（组长）单位地址：

上海市徐汇区枫林路180号

Primary sponsor's address：

No 180 Fenglin 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(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

复旦大学附属中山医院

具体地址：

上海市徐汇区枫林路180号

Institution
hospital：

Zhongshan Hospital Fudan University

Address：

No 180 Fenglin Road, XuHui District, Shanghai

经费或物资来源：

中山医院科室发展基金

Source(s) of funding：

Development Fund of Zhongshan Hospital

Target disease：

Essential Tremor, Parkinson Disease, neuronal intranuclear inclusion 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：

评价腕部佩戴低频治疗仪经皮传入模式刺激(TAPS)疗法与假刺激对比，缓解不同中枢性或者外周性疾病造成中重度震颤患者震颤症状的有效性和安全性  

Objectives of Study：

Evaluate the efficacy and safety of transcutaneous afferent pattern stimulation (TAPS) therapy using a low-frequency therapeutic device worn on the wrist, compared to sham stimulation, in alleviating tremor symptoms in patients with moderate to severe tremor caused by various central or peripheral diseases

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.年龄≥18岁，性别不限 2.诊断为特发性震颤、帕金森病、NIID或者周围神经病伴有震颤 3.TETRAS上肢评分至少有1项≥2分（对于特发性震颤、NIID或者周围神经病性震颤），或者UPDRS 上肢震颤评分至少1项≥2分(对于帕金森病)； 4.自愿参加临床试验，且能签署知情同意书； 5.能够完成随访及评估问卷

Inclusion criteria

1.Aged >=18 years, with no gender preference; 2. Diagnosed with essential tremor, Parkinson's disease, NIID, or peripheral neuropathy accompanied by tremor; 3. At least one item in the TETRAS upper limb score is >=2 (for essential tremor, NIID, or peripheral neuropathic tremor), or at least one item in the UPDRS upper limb tremor score is >=2 (for Parkinson's disease); 4. Voluntarily participate in clinical trials and be able to sign the informed consent form; 5.Able to complete follow-up and evaluation questionnaires.

排除标准：

1. 有植入式电子医疗设备史，如起搏器、除颤器或深部脑刺激器; 2. 既往接受过目的为治疗震颤的丘脑切断术，包括立体定向丘脑切断术、伽马刀放射外科丘脑切断术和聚焦超声丘脑切断术; 3. 既往诊断或疑似诊断为癫痫; 4. 孕妇或哺乳期女性; 5. 刺激部位存在皮肤肿胀、感染、发炎或皮肤出疹、开放性伤口或皮肤癌变; 6. 影响靶上肢检查的周围神经病变; 7. 酗酒; 8. 靶上肢震颤由特发性震颤、帕金森病、神经元核内包涵体病、周围神经病以 外的病因引起; 9. 入组前3个月内服用过抗抑郁药物; 10. 入组前 6 个月注射过肉毒杆菌治疗手部震颤; 11. 入组前 12 小时饮酒或摄入过咖啡因; 12. 其他原因导致研究者认为不适合参加本次试验的患者.

Exclusion criteria：

1. History of implanted electronic medical devices, such as pacemakers, defibrillators, or deep brain stimulators; 2. Previous thalamotomy for the treatment of tremor, including stereotactic thalamotomy, gamma knife radiosurgery thalamotomy, and focused ultrasound thalamotomy; 3. Previous diagnosis or suspected diagnosis of epilepsy; 4. Pregnant or lactating women; 5. Skin swelling, infection, inflammation, or skin rash, open wound, or skin cancer at the stimulation site; 6. Peripheral neuropathy affecting the examination of the target upper limb; 7. Alcohol abuse; 8. Target upper limb tremor caused by causes other than essential tremor, Parkinson's disease, neuronal intranuclear inclusion disease, or peripheral neuropathy; 9. Use of antidepressants within 3 months before enrollment; 10. Botulinum toxin injection for hand tremor within 6 months before enrollment; 11. Consumption of alcohol or caffeine within 12 hours before enrollment; 12. Other reasons that led the investigator to consider the patient unsuitable for participation in this trial.

研究实施时间：

Study execute time：

从 From 2026-05-10 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-10 00:00:00 至 To 2027-06-30 00:00:00  

干预措施：

Interventions：

组别：

TAPES治疗组

样本量：

88

Group：

TAPES treatment

Sample size：

干预措施：

使用治疗手环形状的设备和腕带，腕带处有电极在受试者腕横纹处对正中神经和桡神经交替进行电刺激，刺激频率根据震颤频率标定，电流强度4-5mA治疗40分钟。

干预措施代码：

Intervention：

Using a device shaped like a therapeutic wristband and a wrist strap, electrodes on the wrist strap alternately deliver electrical stimulation to the median and radial nerves at the wrist crease of the subject. The stimulation frequency is calibrated according to the tremor frequency, with a current intensity of 4-5mA for a treatment duration of 40 minutes.

Intervention code：

组别：

假刺激对照组

样本量：

88

Group：

Sham stimulation

Sample size：

干预措施：

采用同样的外观的手环和腕带，腕带内部被破坏而不能产生有效的电刺激作用，同样调整电流强度至4-5mA佩戴治疗40分钟

干预措施代码：

Intervention：

Using a wristband and a bracelet with the same appearance, the interior of the wristband was damaged and could not generate effective electrical stimulation. Similarly, the current intensity was adjusted to 4-5mA and worn for 40 minutes of treatment

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)：

复旦大学附属中山医院 

单位级别：

三甲 

Institution
hospital：

Zhongshan hospital Fudan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

震颤幅度

指标类型：

主要指标

Outcome：

Tremor amplitude

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

震颤功率

指标类型：

次要指标

Outcome：

Tremor Power

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TETRAS上肢评分

指标类型：

次要指标

Outcome：

The Essential Tremor Rating Assessment Scale score for upper extremities

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

UPDRSIII 震颤评分（M20，M21)

指标类型：

次要指标

Outcome：

UPDRSIII tremor score(M20,M21)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗后临床印象改善量表

指标类型：

次要指标

Outcome：

Clinical Global Impressions Scale of Improvement

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件发生率

指标类型：

副作用指标

Outcome：

Rate of adverse events

Type：

Adverse events

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 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）：

随机化方法采用分层区组随机方法，先根据不同疾病队列进行分层，在每个层内再进行区组随机。具体步骤：1、确定分层因素：根据研究目的和不同疾病队列分组，以不同疾病种类作为分层变量，共分4层；2、设定区组大小：根据处理组的数量等因素选择区组长度；3、生成随机序列：采用统计软件生成分层区组随机化序列，确保每个层内各区组的分配顺序随机且符合预设比例.

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

The randomization method employed a stratified block randomization approach. Initially, stratification was conducted based on different disease cohorts, followed by block randomization within each stratum. The specific steps are as follows: 1. Determine stratification factors: Based on the research objectives and grouping of different disease cohorts, different disease types were used as stratification variables, resulting in a total of four strata; 2. Set block size: The block length was selected based on factors such as the number of treatment groups; 3. Generate random sequence: A statistical software was used to generate a stratified block randomization sequence, ensuring that the allocation sequence of each block within each stratum was random and in accordance with the preset proportion; 4. Randomization concealment and execution using the envelope method. The calculated randomization scheme was stored in an opaque envelope in advance.

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：

随机化后，非盲态研究人员按照随机化的分组调试TAPS设备的腕带—TAPS治疗组使用正常的设备和腕带，而假刺激治疗组使用正常的设备和内部结构被破坏的腕带。调试后非盲态研究人员将设备交给盲态的实施治疗医师进行治疗。TAPS治疗组使用治疗手环形状的设备和腕带，腕带处有电极在受试者腕横纹处对正中神经和桡神经交替进行电刺激，刺激频率根据震颤频率标定，电流强度4-5mA治疗40分钟。假刺激治疗采用同样的外观的手环和腕带，腕带内部被破坏而不能产生有效的电刺激作用，同样调整电流强度至4-5mA佩戴治疗40分钟。治疗前后进行量表和表面肌电图震颤分析评估，对受试者和实施治疗和评估的医师均进行设盲。

Blinding：

After randomization, unblinded researchers debugged the wrist strap of taps equipment according to the randomized grouping - the taps treatment group used normal equipment and wrist strap, while the sham stimulation treatment group used normal equipment and wrist strap with damaged internal structure. After commissioning, the unblinded researcher will hand over the equipment to the blinded implementing treating physician for treatment. The taps treatment group used the device and wristband in the shape of a treatment bracelet. The electrode at the wristband alternately stimulated the median nerve and radial nerve at the transverse stria of the wrist of the subject. The stimulation frequency was calibrated according to the tremor frequency, and the current intensity was 4-5mA for 40 minutes. Sham stimulation treatment uses bracelets and wristbands with the same appearance. The interior of the wristband is damaged and cannot produce effective electrical stimulation. Similarly, adjust the current intensity to 4-5mA to wear for 40 minutes. Before and after treatment, the scales and surface electromyography tremor analysis were carried out, and the subjects and physicians who implemented the treatment and evaluation were blinded.

是否共享原始数据：

IPD sharing

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）：

不共享原始数据

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

Do not share raw data

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：

研究者通过原始病历记录和填写纸质病例报告表，对试验过程数据加以记录。研究者需对录入数据的质量负责，确保数据的真实性和完整性。研究者需要定期核对原始病历记录和病理报告表中数据的一致性。数据管理过程中，将派专人对数据进行逻辑性核查，发现不合理或者错误数据将通知研究者进行修改。

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

Researchers record the trial process data through original medical records and by filling out paper case report forms. Researchers are responsible for the quality of the entered data, ensuring its authenticity and integrity. They need to regularly verify the consistency of data between the original medical records and the case report forms. During the data management process, dedicated personnel will conduct logical verification of the data, and any unreasonable or erroneous data will be notified to the researchers for modification.

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：

  2026-04-23 17:09:21