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Clinical Study on the Diagnostic Accuracy of Trigeminal Somatosensory Evoked Potentials (TSEP) in the Diagnosis of Trigeminal Nerve Lesions

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注册号：

Registration number：

ChiCTR2600123972 

最近更新日期：

Date of Last Refreshed on：

2026-05-06 09:40:54 

注册时间：

Date of Registration：

2026-05-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

三叉神经体感诱发电位（TSEP）在诊断三叉神经病变中的诊断准确性研究

Public title：

Clinical Study on the Diagnostic Accuracy of Trigeminal Somatosensory Evoked Potentials (TSEP) in the Diagnosis of Trigeminal Nerve Lesions

注册题目简写：

English Acronym：

研究课题的正式科学名称：

三叉神经体感诱发电位（TSEP）在诊断三叉神经病变中的诊断准确性研究

Scientific title：

Clinical Study on the Diagnostic Accuracy of Trigeminal Somatosensory Evoked Potentials (TSEP) in the Diagnosis of Trigeminal Nerve Lesions

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：

熊其瑗 

研究负责人：

熊其瑗 

Applicant：

Xiong Qiyuan 

Study leader：

Xiong Qiyuan 

申请注册联系人电话：

Applicant telephone：

+86 21 64043629

研究负责人电话：

Study leader's telephone：

+86 21 64043629

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：

qiyuanxiong0418@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

xiong.qiyuan@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：

中国上海市徐汇区枫林路180号

研究负责人通讯地址：

中国上海市徐汇区枫林路180号

Applicant address：

180 Fenglin Road, Xuhui District, Shanghai, China

Study leader's address：

180 Fenglin Road, Xuhui District, Shanghai, China

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：

B2026-218

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：

Medical Ethics Committee of Zhongshan Hospital Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-04-10 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：

中国上海市徐汇区枫林路180号

Contact Address of the ethic committee：

180 Fenglin Road, Xuhui District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 31587871

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yang.mengjie@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：

中国上海市徐汇区枫林路180号

Primary sponsor's address：

180 Fenglin Road, Xuhui District, Shanghai, China

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：

中国上海市徐汇区枫林路180号

Institution
hospital：

Zhongshan Hospital, Fudan University

Address：

180 Fenglin Road, Xuhui District, Shanghai, China

经费或物资来源：

自筹

Source(s) of funding：

Self funding

Target disease：

Trigeminal Nerve Dysfunction / Trigeminal Neuropathy

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

本研究的主要目的是评估三叉神经体感诱发电位（TSEP）对三叉神经病变的诊断效能及其准确性。次要目的包括：（1）计算TSEP诊断三叉神经病变的灵敏度、特异性、阳性预测值和阴性预测值，目标灵敏度≥80%、特异性≥80%；（2）分析TSEP参数在中枢性与周围性三叉神经病变中的特征差异；（3）探讨TSEP异常模式与患者临床表现、影像学结果的关联性；（4）验证TSEP在早期或亚临床功能性三叉神经损害中的诊断价值。  

Objectives of Study：

The primary objective of this study is to evaluate the diagnostic performance and accuracy of Trigeminal Somatosensory Evoked Potentials (TSEP) for trigeminal neuropathy. The secondary objectives include: (1) calculate the sensitivity, specificity, positive predictive value, and negative predictive value of TSEP for diagnosing trigeminal neuropathy, with target sensitivity ≥80% and specificity >=80%; (2) analyze the characteristic differences of TSEP parameters between central and peripheral trigeminal neuropathy; (3) explore the correlation between TSEP abnormality patterns and clinical manifestations as well as imaging findings; (4) validate the diagnostic value of TSEP in early or subclinical functional trigeminal nerve impairment.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

病例组入选标准，符合以下条件者可纳入病例组： 1.年龄 18～75 岁，性别不限，能够配合完成 TSEP 检测及相关资料采集； 2.存在提示三叉神经病变的临床症状或体征，包括但不限于：面部感觉减退 或感觉异常、阵发性刺痛/灼痛、咀嚼无力、角膜反射异常等，且症状持续 时间≥1 周； 3.依据临床综合诊断流程（本研究金标准），被判断为疑似或确诊三叉神经 病变，病变类型可包括中枢性（如脑血管疾病、脱髓鞘性病变等）或周围 性（如神经卡压、炎症、外伤等）； 4.入选前未接受针对三叉神经病变的侵入性治疗（如神经阻滞或手术治疗）； 5.如已接受药物治疗，需维持相对稳定的用药方案≥2 周； 6.自愿签署知情同意书，依从性良好，并能够配合完成研究检测。 健康对照组入选标准，符合以下条件者可纳入健康对照组： 1) 年龄 18～75 岁，性别不限，能够配合完成 TSEP 检测及相关资料采集； 2) 同期就诊且相关检查无明显异常； 3) 无面部感觉异常、阵发性或持续性面部疼痛、咀嚼无力等提示三叉神经病变的症状或体征； 4) 神经系统专科检查显示三叉神经分布区感觉、运动及相关反射功能均正常； 5) 无已知可能影响三叉神经功能的疾病史：通过详细询问病史和查阅既往诊疗记录，确认无中枢或周围神经系统疾病史（如脑血管疾病、颅内肿瘤、多发性硬化、颅脑外伤等）、无可能导致神经功能异常的全身性疾病（如糖尿病、尿毒症等）； 6) 入组前 3 个月内未使用可能影响神经传导功能的药物（如抗癫痫药、镇静催眠药或具有明确神经毒性的药物）； 7) 无明确中枢或周围神经系统疾病史； 8) 自愿签署知情同意书，依从性良好。

Inclusion criteria

Case group inclusion criteria: those who met the following conditions were included in the case group: 1.Age of 18-75 years old, both sexes, able to cooperate to complete TSEP detection and related data collection; 2.The presence of clinical symptoms or signs suggestive of trigeminal neuropathy, including but not limited to facial hypoesthesia Or paresthesia, paroxysmal stinging/burning pain, chewing weakness, abnormal corneal reflex, etc., and the symptoms persist Time ≥1 week; 3.suspected or confirmed trigeminal nerve according to the clinical comprehensive diagnostic process (the gold standard of this study) Lesions, the type of lesions can include central (such as cerebrovascular diseases, demyelinating lesions, etc.) or peripheral Sex (such as nerve compression, inflammation, trauma, etc.); 4.no invasive treatment (e.g., nerve block or surgery) for trigeminal neuropathy before enrollment; 5.Maintain a relatively stable medication regimen for at least 2 weeks if they have already received drug therapy; 6.signed the informed consent form voluntarily with good compliance, and were able to cooperate to complete the study test. The inclusion criteria of healthy control group were as follows: 1) Age of 18-75 years old, both sexes, able to cooperate to complete TSEP detection and related data collection; 2) Patients visited the hospital at the same time without obvious abnormalities in related examinations; 3) There was no facial paresthesia, paroxysmal or persistent facial pain, chewing weakness or other symptoms or signs suggestive of trigeminal neuropathy; 4) Neurological examination showed that the sensory, motor and related reflex functions of the trigeminal nerve distribution area were normal; 5) No history of diseases known to affect the function of the trigeminal nerve: no history of central or peripheral nervous system diseases (such as cerebrovascular diseases, intracranial tumors, multiple sclerosis, craniocerebral trauma, etc.) and no systemic diseases that could cause neurological dysfunction (such as diabetes, uremia, etc.) were confirmed by detailed medical history and review of previous medical records. 6) no use of drugs that may affect nerve conduction function (such as antiepileptic drugs, sedative-hypnotics, or drugs with definite neurotoxicity) within 3 months before enrollment; 7) no clear history of central or peripheral nervous system diseases; 8) Informed consent was signed voluntarily with good compliance.

排除标准：

1.合并影响面部肌肉不自主运动或静止状态维持的疾病，如Meige综合征、 面肌痉挛、口面部肌张力障碍、严重抽动障碍等，可能干扰 TSEP 检测过 程中刺激实施、电极稳定性及波形判读；
2.合并其他明显影响面部感觉或疼痛评估的颅神经病变（如舌咽神经痛等，导致三叉神经功能异常难以单独判定；
3.合并严重全身系统性疾病（如重度心、肝、肾功能不全、活动性恶性肿瘤等），研究者认为可能影响神经功能或无法配合检测；
4.妊娠期或哺乳期女性；
5.存在明显认知功能障碍、严重精神疾病或意识障碍，无法理解研究内容或配合完成检测；
6.头部存在皮肤破损、感染或固定性金属植入物，影响电极放置或信号采集；
7.入组前 3 个月内发生严重头部外伤、颅内手术或急性脑血管事件；
8.长期使用显著影响神经电生理信号的药物且无法维持稳定用药；
9.对检测所用电极或导电材料过敏，或因体位、运动受限无法完成标准化检测；
10.既往明确癫痫病史或存在癫痫发作高风险，研究者认为不适合接受刺激性 电生理检查。

Exclusion criteria：

1.Concomitant diseases affecting involuntary movement or maintenance of immobility of facial muscles, such as Meige syndrome, Hemifacial spasm, orofacial dystonia, severe tic disorders, etc. may interfere with TSEP detection Intraoperative stimulation, electrode stability and waveform interpretation;
2.combined with other cranial neuropathy that significantly affects facial sensation or pain assessment (such as glossopharyngeal neuralgia), As a result, it is difficult to determine the trigeminal nerve dysfunction alone.
3.complicated with serious systemic diseases (such as severe heart, liver, kidney dysfunction, active malignant tumor) The researchers thought that it might affect the neurological function or be unable to cooperate with the test;
4.pregnant or lactating women;
5.with obvious cognitive impairment, severe mental illness or disturbance of consciousness, unable to understand the study content or cooperate with the test;
6.The presence of skin damage, infection or fixed metal implants in the head, affecting electrode placement or signal acquisition;
7.severe head trauma, intracranial surgery, or acute cerebrovascular event within 3 months before enrollment;
8.long-term use of drugs that significantly affect neurophysiological signals and cannot be maintained stably;
9.Allergy to the electrodes or conductive materials used in the test, or inability to complete the standardized test due to limited posture or movement;
10.patients with a definite history of epilepsy or a high risk of seizures were considered by the investigator to be ineligible for stimulation electrophysiological study.

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2028-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-11 00:00:00 至 To 2028-01-31 00:00:00  

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

本研究将与三叉神经病变容易混淆的疾病（包括特发性面麻、非典型面痛、颞下颌关节紊乱病）纳入健康对照组，不单独设立易混淆疾病组。这些疾病患者虽表现为面部感觉异常或疼痛，但经临床综合诊断标准（《特发性与继发性三叉神经痛诊疗专家共识（2025版）》）判定不属于三叉神经病变。通过纳入此类易混淆病例，可更真实地模拟临床实际场景，评估三叉神经体感诱发电位（TSEP）对三叉神经病变的鉴别诊断效能。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

In this study, conditions easily confused with trigeminal neuropathy (including idiopathic facial numbness, atypical facial pain, and temporomandibular joint disorder) are enrolled as part of the healthy control group, without establishing a separate group for easily confused diseases. Although thes

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

三叉神经体感诱发电位

Index test:

Trigeminal somatosensory evoked potential

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

本研究的目标人群为18-75岁存在三叉神经病变相关症状（如面部感觉异常、疼痛、麻木、刺痛、烧灼感或咀嚼无力）的患者，包括由脑血管疾病、颅内肿瘤、脱髓鞘病变、外伤等多种病因引起的三叉神经功能障碍。疾病谱涵盖中枢性及周围性三叉神经病变，包括临床确诊及亚临床/早期功能性损害阶段。病例组将按照临床综合诊断标准（《特发性与继发性三叉神经痛诊疗专家共识（2025版）》）纳入，确保覆盖不同病程、不同严重程度和不同病因的患者，具有良好的疾病谱完整性和代表性。

例数:

Sample size:

55

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

The target population of this study is patients aged 18-75 years with symptoms related to trigeminal neuropathy, such as facial sensory abnormalities, pain, numbness, tingling, burning sensation, or masticatory weakness, caused by various etiologies including cerebrovascular diseases, intracranial t

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

本研究将与三叉神经病变容易混淆的疾病（包括特发性面麻、非典型面痛、颞下颌关节紊乱病）纳入健康对照组，不单独设立易混淆疾病组。这些疾病患者虽表现为面部感觉异常或疼痛，但经临床综合诊断标准（《特发性与继发性三叉神经痛诊疗专家共识（2025版）》）判定不属于三叉神经病变。通过纳入此类易混淆病例，可更真实地模拟临床实际场景，评估三叉神经体感诱发电位（TSEP）对三叉神经病变的鉴别诊断效能。

例数:

Sample size:

55

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

In this study, conditions easily confused with trigeminal neuropathy (including idiopathic facial numbness, atypical facial pain, and temporomandibular joint disorder) are enrolled as part of the healthy control group, without establishing a separate group for easily confused diseases. Although thes

研究实施地点：

Countries of recruitment and research settings：

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 

单位级别：

三级甲等 

Institution
hospital：

Zhongshan Hospital, Fudan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

三叉神经体感诱发电位

指标类型：

主要指标

Outcome：

Trigeminal Somatosensory Evoked Potential (TSEP)

Type：

Primary indicator

测量时间点：

入组时（基线期），单次测量

测量方法：

采用Keypoint? G4 EMG / NCS / EP Workstation。记录电极为一次性无菌针灸针，放置于C5/C6（国际10-10系统），参考电极为Fpz。分别刺激三叉神经三个分支：V1（眶上神经）、V2（上颌神经）、V3（下颌神经）。刺激参数：频率3.1Hz，脉宽60μs，强度为感觉阈值上加2mA且不超过30mA。通过针灸针记录电极分别采集各分支刺激下的TSEP波形。

Measure time point of outcome：

At enrollment (baseline period), single measurement

Measure method：

Keypoint? G4 EMG / NCS / EP Workstation，TSEP recorded from V1, V2, and V3 stimulation using disposable sterile acupuncture needle as recording electrode。

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 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）：

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

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）：

无

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

None

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：

病例记录表

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

Case record form,CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-05-06 09:40:26
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