ChiCTR2500103245 版本V1.0 版本创建时间2025/05/27 10:55:38 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：

 ChiCTR2500103245 

最近更新日期：

Date of Last Refreshed on：

 2025-05-27 10:55:24 

注册时间：

Date of Registration：

 2025-05-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

外周磁刺激治疗重症面神经炎临床疗效研究

Public title：

Clinical efficacy of peripheral magnetic stimulation in the treatment of facial paralysis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

外周磁刺激治疗重症面神经炎临床疗效研究

Scientific title：

Clinical efficacy of peripheral magnetic stimulation in the treatment of facial paralysis

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：

毛也然 

研究负责人：

毛也然 

Applicant：

Mao Yeran 

Study leader：

Mao Yeran 

申请注册联系人电话：

Applicant telephone：

 +86 18621065251

研究负责人电话：

Study leader's
telephone：

+86 18621065251

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：

 1429700284@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1429700284@qq.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：

上海市宝山区友谊路181号

研究负责人通讯地址：

上海市宝山区友谊路181号

Applicant address：

181 Youyi Road, Baoshan District, Shanghai

Study leader's address：

181 Youyi Road, Baoshan 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：

上海市宝山区中西医结合医院

Applicant's institution：

Shanghai Baoshan Hospital of Integrated Chinese and Western Medicine

研究负责人所在单位：

上海市宝山区中西医结合医院

Affiliation of the Leader：

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western 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：

 2024K11

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：

上海市宝山区中西医结合医院伦理委员会

Name of the ethic committee：

Institutional Review Board of Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-07-18 00:00:00

伦理委员会联系人：

芮兴

Contact Name of the ethic committee：

Rui Xing

伦理委员会联系地址：

上海市宝山区友谊路181号

Contact Address of the ethic committee：

181 Youyi Road, Baoshan District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 56177192

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 riyising@163.com

研究实施负责（组长）单位：

上海市宝山区中西医结合医院

Primary sponsor：

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine

研究实施负责（组长）单位地址：

上海市宝山区友谊路181号

Primary sponsor's address：

181 Youyi Road, Baoshan 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)：

上海市宝山区中西医结合医院

具体地址：

上海市宝山区友谊路181号

Institution
hospital：

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine

Address：

181 Youyi Road, Baoshan District, Shanghai

经费或物资来源：

宝山区卫生健康委优青（育才）计划

Source(s) of funding：

Baoshan District Health Commission Excellent Youth (Yucai) Program

研究疾病：

面神经炎  

Target disease：

All the patients with Bell facial palsy were selected as outpatients in the rehabilitation department of our hospital.Subjects in sequelae stage of peripheral facial palsy should exclude peripheral facial nerve paralysis caused by facial neuroma, intracranial trauma, brain stem hemorrhage or infarction, and suppurative inflammation. The course of the disease was longer than 3 months.

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：

从改善症状、电生理和影像的角度，论证脉冲磁刺激治疗难治性面瘫的疗效。为临床提供有效的、可复制、可推广的治疗方案。  

Objectives of Study：

To demonstrate the therapeutic effect of pulsed magnetic stimulation on refractory facial palsy from the perspective of improving symptoms, electrophysiology and imaging. To provide an effective, reproducible and extendable treatment plan for the clinic.

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.经过大于 3 个月的保守治疗（针灸以及口服药物）疗效不显著的面神经炎患者。
2.患者年龄：18 岁<=患者年龄<=90 岁；
3.神经电兴奋试验，两侧差大于 3.5mA 提示轴突、内膜性神经中断或者束膜性 神经中断导致的面神经不可逆变性。
4.House-Brackmann 面神经评级系统评估为 III-VI 级（中-重度面瘫），且出现 面肌联动症状。

Inclusion criteria

1.Patients with facial neuritis with no significant response after more than 3 months of conservative treatment (acupuncture and oral drugs).
2.Patient age:18 years old <=Patient age<=90 years old;
3.In nerve electrical excitation test, bilateral difference greater than 3.5mA indicated irreversible degeneration of facial nerve caused by axon, intimal nerve interruption or fascicular nerve interruption.
4.The House-Brackmann facial nerve rating system was evaluated as grade III-VI (moderate to severe facial paralysis), and facial muscle linkage symptoms were present.

排除标准：

1.神经电兴奋试验，10mA刺激无反应为神经全断导致的失神经支配。
2.神经电兴奋试验，小于3.5mA，提示只是暂时性的神经失用，面神经功能可以恢复。
3.因面神经瘤、颅内外伤、脑干出血或梗死所导致的面神经麻痹。
4.有MRI、电生理、TMS的禁忌症，如金属颅内或颅外植入物。
5.认知障碍或任何实质性疾病。
6.已知服用干扰皮层兴奋性的药物，如GABA\苯二氮卓类及巴氯芬等药物至少在研究前2周停止使用。

Exclusion criteria：

1.Neuroelectric excitation test, no response to 10mA stimulation indicates complete nerve dysfunction due to nerve root injury.
2.Neuroelectric excitation test with less than 3.5mA suggests only temporary nerve dysfunction, and facial nerve function can be restored.
3.Facial nerve paralysis caused by trigeminal nerve tumor, intracranial and extracranial injury, cerebellar hemorrhage or infarction.
4.MRI, electrophysiology, and TMS contraindications, such as metal implants in the cranial or cranial cavity.
5.Cognitive impairment or any significant underlying disease.
6.Known to be taking drugs that interfere with cortical excitability, such as GABA, benzodiazepines, and baclofen, and stopped at least 2 weeks prior to the study.

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

磁刺激组

样本量：

 25

Group：

Magnetic stimulation group

Sample size：

干预措施：

面功能训练的基础上增加外周面神经的磁刺激治疗

干预措施代码：

Intervention：

On the basis of facial function training, magnetic stimulation of peripheral facial nerve was added

Intervention code：

组别：

对照组

样本量：

 25

Group：

Control group

Sample size：

干预措施：

面功能训练

干预措施代码：

Intervention：

Facial function training

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)：

 上海市宝山区中西医结合医院 

单位级别：

 三级甲等 

Institution
hospital：

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

面神经变性的程度（ENoG）

指标类型：

次要指标

Outcome：

Degree of facial nerve degeneration (ENoG)

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

面神经变性的程度（ENoG）是以健侧面神经电图的振幅与患侧面神经电图的振幅的比例表示，计算公式是：神经变性百分比＝(健侧振幅－患侧振幅)/健侧振幅。面神经纤维的变性程度同面肌纤维的失神经程度成正比。

Measure time point of outcome：

Before and after treatment

Measure method：

The degree of facial neurodegeneration (ENoG) is expressed as the ratio of the amplitude of the electroneurogram of the healthy side to the amplitude of the electroneurogram of the affected side, calculated by the formula: percentage of neurodegeneration = (healthy side amplitude - affected side amplitude)/ healthy side amplitude. The degree of degeneration of facial nerve fibers is proportional to the degree of denervation of facial muscle fibers.

指标中文名：

口眼联动运动的影像客观评估

指标类型：

次要指标

Outcome：

Image objective evaluation of mouth-eye linkage movement

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

评估口眼联动运动的影像客观评估 通过嘴部运动期间眼裂间隙宽度的不对称程度来评估口-眼联动的程度。使用数字录像机（PowerShot G9 X Mark II；Canon，Tokyo，Japan）对患者在三次指定的嘴部运动期间在正面视图上的面部运动进行录像。使用Video Studio软件X9软件（加拿大渥太华的Corel）拍摄了相同的三个指定最大嘴巴运动期间的静止面部图像。使用Adobe Phot

Measure time point of outcome：

Before and after treatment

Measure method：

Image objective assessment of mouth - eye linkage movement The degree of mouth-eye linkage was evaluated by the degree of asymmetry in the width of the eye gap during mouth movement. Use a digital video recorder (PowerShot G9 X Mark II; Canon, Tokyo, Japan) videotapes the patient's facial movements on a frontal view during three designated mouth movements. Still facial images during the same three designated maximum mouth movements were taken using Video Studio software X9 software (Corel of Ott

指标中文名：

Fisch面功能评分指标

指标类型：

主要指标

Outcome：

Fisch face features score indicators

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

Fisch面功能评分指标11共有5项，满分为100分。其中静态占20分，抬眉占10分，闭眼占30分，笑或者露齿占30分，鼓腮占10分。每项分数又分为4档，分别是0％，l30％，l70％和100％，5项的实得分相加即为实际得分。

Measure time point of outcome：

Before and after treatment

Measure method：

Fisch has 5 functional rating indicators 11, with a maximum score of 100. Among them, 20 points are static, 10 points are raised eyebrows, 30 points are closed eyes, 30 points are smiling or flashing teeth, 10 points are bulging cheeks. Each score is divided into 4 grades, which are 0%, l30%, l70% and 100%, and the actual score of the 5 items is added together.

指标中文名：

面神经电图的振幅

指标类型：

次要指标

Outcome：

Amplitude of facial nerve electroencephalogram

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

面神经电图的振幅：面神经电图的振幅：表面电极所记录的面肌复合动作电位的幅度与轴索完整性和同步性直接有关。在茎乳孔外的面神经主干体表进行电刺激，口轮匝肌处记录。面神经电图的振幅相当于面神经兴奋程度。

Measure time point of outcome：

Before and after treatment

Measure method：

The amplitude of the facial nerve electromyogram: The amplitude of the facial muscle compound action potential recorded by the surface electrode is directly related to the integrity and synchrony of the axon. Perform electrical stimulation on the surface of the main trunk of the facial nerve outside the stylomastoid foramen, and record at the orbicularis oris muscle. The amplitude of the facial nerve electroencephalogram is equivalent to the level of facial nerve excitation.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

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 90 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）：

在实施随机双盲试验时，首先由统计分配者使用统计软件包生成两套各25个随机分组编号。这些编号在形成后会被记录在文件中，并由申办方和统计人员密封保存，确保双盲的实施。

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

In the randomized double-blind experiment, the statistical distributor used the statistical software package to generate two sets of 50 random group numbers. These numbers are recorded in the document after formation and are kept sealed by the sponsor and statisticians to ensure the implementation of double blindness.

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：

双盲

Blinding：

Double blind

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）：

任意时间与研究者联系，通过邮件共享。邮箱：1429700284@qq.com

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

Any time contact researchers and share data via email. Email: 1429700284@qq.com

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：

数据采集和管理，由实验组人员统计并撰写病例记录表（CRF),并由专员输入电子采集和管理系统进行数据统一管理（EDC）

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

Data collection and management: the experimental group counted and wrote the case record form (CRF), and the specialist entered the electronic collection and management system for unified data management (EDC).

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-05-27 10:55:24