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双侧重复经颅磁刺激改善青少年非自杀性自伤情绪调节功能的随机对照探索性研究临床试验
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注册号：

Registration number：

 ChiCTR2600123081 

最近更新日期：

Date of Last Refreshed on：

 2026-04-21 16:04:26 

注册时间：

Date of Registration：

 2026-04-21 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

双侧重复经颅磁刺激改善青少年非自杀性自伤情绪调节功能的随机对照探索性研究临床试验

Public title：

Bilateral Repetitive Transcranial Magnetic Stimulation for Emotion Regulation in Adolescents with Non-Suicidal Self-Injury: A Randomized Controlled Exploratory Clinical Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

双侧重复经颅磁刺激改善青少年非自杀性自伤情绪调节功能的随机对照探索性研究临床试验

Scientific title：

Bilateral Repetitive Transcranial Magnetic Stimulation for Emotion Regulation in Adolescents with Non-Suicidal Self-Injury: A Randomized Controlled Exploratory Clinical Trial

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：

郑家仁 

研究负责人：

郑家仁 

Applicant：

Zheng Jiaren  

Study leader：

Zheng Jiaren  

申请注册联系人电话：

Applicant telephone：

 +86 159 6057 8990

研究负责人电话：

Study leader's
telephone：

+86 159 6057 8990

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：

 150482573@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 150482573@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：

福建省晋江市陈埭镇湖中村南片174号

研究负责人通讯地址：

福建省晋江市陈埭镇湖中村南片174号

Applicant address：

No. 174, South Section, Huzhu Village, Chendai Town, Jinjiang City, Fujian Province, China

Study leader's address：

No. 174, South Section, Huzhu Village, Chendai Town, Jinjiang City, Fujian Province, 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：

福建省晋江市第三医院

Applicant's institution：

The Third Hospital of Jinjiang,Fujian,China

研究负责人所在单位：

福建省晋江市第三医院

Affiliation of the Leader：

The Third Hospital of Jinjiang,Fujian,China

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：

 2025年审(002)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：

晋江市第三医院医学伦理管理委员会

Name of the ethic committee：

Medical ethics management committee of The Third Hospital of Jinjiang

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-15 00:00:00

伦理委员会联系人：

苏祖森

Contact Name of the ethic committee：

Su Zusen

伦理委员会联系地址：

福建省晋江市陈埭镇湖中村南片174号

Contact Address of the ethic committee：

No. 174, South Section, Huzhu Village, Chendai Town, Jinjiang City, Fujian Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 595 8677 7273

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：

晋江市第三医院

Primary sponsor：

The Third Hospital of Jinjiang

研究实施负责（组长）单位地址：

福建省晋江市陈埭镇湖中村南片174号

Primary sponsor's address：

No. 174, South Section, Huzhu Village, Chendai Town, Jinjiang City, Fujian Province, 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)：

福建

市(区县)：

晋江

Country：

China

Province：

Fujian

City：

Jinjiang

单位(医院)：

晋江市第三医院

具体地址：

福建省晋江市陈埭镇湖中村南片174号

Institution
hospital：

The Third Hospital of Jinjiang

Address：

No. 174, South Section, Huzhu Village, Chendai Town, Jinjiang City, Fujian Province, China

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

青少年情绪障碍伴非致死性自伤  

Target disease：

Adolescent emotional disorders with non-suicidal self-injury

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.主要目的： 评价双侧DLPFC序贯rTMS（左高频+右低频）联合常规药物治疗，在改善12~18岁NSSI青少年患者情绪调节困难、减少非自杀性自伤行为方面的临床有效性及用药/治疗安全性。 2.次要目的： （1）对比rTMS+药物组、伪刺激+药物组、单纯药物组受试者治疗前后冲动行为、焦虑、抑郁症状及MMN波幅/潜伏期的变化差异； （2）探索治疗前后MMN波幅、潜伏期的变化规律，分析其与情绪调节、冲动行为改善程度的相关性，结合国内相关研究进展[10]，验证MMN作为青少年NSSI干预疗效预测/评估生物标志物的潜力； （3）明确双侧序贯rTMS联合常规药物在青少年NSSI治疗中的临床增量价值，为临床治疗方案选择提供依据。  

Objectives of Study：

1. Primary Objective To evaluate the clinical efficacy and treatment safety of sequential bilateral DLPFC rTMS (high-frequency left + low-frequency right) combined with routine pharmacotherapy in improving emotion regulation difficulties and reducing non-suicidal self-injury behaviors among adolescents aged 12–18 years with NSSI. 2. Secondary Objectives (1) To compare changes in impulsive behaviors, anxiety, depressive symptoms, and MMN amplitude/latency among subjects in the rTMS + medication group, sham stimulation + medication group, and medication-only group before and after treatment. (2) To explore the changing patterns of MMN amplitude and latency before and after treatment, analyze their correlations with improvements in emotion regulation and impulsive behaviors, and verify the potential of MMN as a biomarker for predicting or evaluating intervention efficacy in adolescent NSSI, combined with domestic research progress [10]. (3) To clarify the incremental clinical value of sequential bilateral rTMS combined with routine pharmacotherapy in the treatment of adolescent NSSI, and to provide evidence for the selection of clinical treatment regimens.

药物成份或治疗方案详述：

干预措施 所有干预措施均持续4周，每周5次（周一至周五），总计20次。干预期间统一制定随访计划，全程严格监测干预依从性及安全性。 rTMS治疗： 采用国内获批的rTMS专用治疗设备（如依瑞德武汉CCY-Ⅱ系列）开展治疗，所有操作均由经过专业培训、具备资质的医师完成，严格遵循标准化流程：①测定参与者双侧手第一背侧骨间肌的静息运动阈值（resting motor threshold, MT），作为刺激强度参考；② 依据国际10-20脑电图系统，定位左、右侧DLPFC刺激靶点（F3、F4位点），并通过头部固定带保持线圈位置稳定。真rTMS组：采用序贯双侧DLPFC刺激方案，严格按照“左高频→右低频”的顺序进行：左侧DLPFC高频刺激（10 Hz，刺激串长1 s，串间间隔7 s, 600脉冲/次，刺激强度80%~120% MT，持续8 min）；右侧DLPFC低频刺激（1 Hz，刺激串长10 s，串间间隔1 s，1200脉冲/次，刺激强度80%~120% MT，持续22 min）。单次治疗总时长30 min，总脉冲数1800次。刺激过程中采用数字评定量表（NRS）实时评估耐受性，并根据评分调整刺激强度，所有参数调整均详细记录。假rTMS组：接受与真rTMS组完全一致的操作流程、线圈放置位置、治疗时长及次数，但使用安慰剂线圈，无有效磁场输出。单纯药物组：不接受任何rTMS干预，仅接受标准化药物治疗及常规临床随访。 药物治疗 为所有参与者建立专用服药依从性日志，由参与者及监护人共同记录。研究人员每周通过日志复核、电话随访或门诊复诊的方式监测服药依从性，依从性<80%者将作为协变量纳入分析。入组前已服药者，维持原方案不变；未服药者，由临床医生根据指南启动常规药物治疗，优先选择SSRI类药物，并制定个体化剂量方案，研究期间尽可能保持剂量稳定。确需调整者，详细记录调整原因、剂量及时间，作为后续统计分析的协变量。全程系统记录合并用药情况。 

Description for medicine or protocol of treatment in detail：

Interventions All interventions will be administered for 4 consecutive weeks, 5 sessions weekly (Monday to Friday), with a total of 20 sessions. A unified follow-up plan will be formulated during the intervention period, and intervention compliance and safety will be rigorously monitored throughout the process. rTMS Treatment rTMS will be performed using domestically approved dedicated rTMS devices (e.g., Wuhan Erei Deer CCY-Ⅱ Series). All procedures will be conducted by professionally trained and qualified physicians in strict compliance with standardized protocols: ① The resting motor threshold (MT) of the bilateral first dorsal interosseous muscles of participants will be measured as the reference for stimulation intensity; ② The stimulation targets of the left and right dorsolateral prefrontal cortex (DLPFC) (sites F3 and F4) will be located in accordance with the international 10-20 electroencephalogram system, and the coil position will be stabilized with a head strap. Active rTMS Group A sequential bilateral DLPFC stimulation protocol will be adopted, following the fixed sequence of high-frequency left DLPFC stimulation followed by low-frequency right DLPFC stimulation: High-frequency stimulation (10 Hz, 1-second train duration, 7-second inter-train interval, 600 pulses per session, 80%–120% MT stimulation intensity, 8-minute duration) will be delivered to the left DLPFC; low-frequency stimulation (1 Hz, 10-second train duration, 1-second inter-train interval, 1200 pulses per session, 80%–120% MT stimulation intensity, 22-minute duration) will be delivered to the right DLPFC. The total duration of a single treatment session is 30 minutes, with a total of 1800 pulses. Tolerability will be assessed in real time using the Numeric Rating Scale (NRS) during stimulation, and stimulation intensity will be adjusted based on the scores, with all parameter adjustments documented in detail. Sham rTMS Group Participants will undergo the exact same operational procedures, coil placement, treatment duration and frequency as the active rTMS group, but with a placebo coil that generates no effective magnetic field output. Medication-Only Group Participants will receive no rTMS intervention, only standardized pharmacotherapy and routine clinical follow-up. Pharmacotherapy A dedicated medication compliance log will be established for all participants, completed jointly by participants and their guardians. Researchers will monitor medication compliance weekly via log review, telephone follow-up or outpatient revisit. Participants with a medication compliance< 80% will be included as a covariate in the analysis. For participants who had been taking medication before enrollment, their original regimens will be maintained; for medication-naïve participants, clinicians will initiate routine pharmacotherapy in accordance with clinical guidelines, with selective serotonin reuptake inhibitors (SSRIs) as the preferred agents, and formulate individualized dosage regimens. Dosage will be kept as stable as possible during the study. If dosage adjustment is truly necessary, the reason, dosage and timing of the adjustment will be recorded in detail and included as covariates in subsequent statistical analyses. Concomitant medications will be systematically recorded throughout the study. 

纳入标准：

Inclusion criteria

排除标准：

1.有癫痫病史、器质性脑病史（如脑外伤、脑血管疾病、脑肿瘤等），或脑电图检查提示癫痫样放电，存在rTMS治疗禁忌证； 2.体内存在金属植入物（如颅骨固定钉、心脏支架等）、电子植入设备（如心脏起搏器、脑深部电刺激器等），或头部有开放性伤口、严重皮肤病； 3.既往接受过rTMS、电抽搐治疗、经颅直流电刺激或其他神经调控治疗； 4.经哥伦比亚-自杀严重程度评定量表（Columbia Suicide Severity Rating Scale, C-SSRS）评估提示高自杀风险； 5.合并严重躯体疾病（如严重心、肝、肾功能不全）、物质滥用/依赖，或存在躁狂发作、精神病性症状等不稳定精神症状，无法配合研究流程； 6.无法提供有效知情同意，或预计不能遵守研究随访及操作程序，脱落风险较高。

Exclusion criteria：

1. History of epilepsy, organic brain disease (e.g., traumatic brain injury, cerebrovascular disease, brain tumor, etc.), or epileptiform discharges on electroencephalogram (EEG), representing contraindications for rTMS treatment; 2. Presence of metallic implants (e.g., skull pins, cardiac stents, etc.), electronic implantable devices (e.g., cardiac pacemakers, deep brain stimulators, etc.), open wounds on the head, or severe dermatological conditions; 3. Previous treatment with rTMS, electroconvulsive therapy (ECT), transcranial direct current stimulation (tDCS), or other neuromodulation therapies; 4. High suicide risk assessed by the Columbia Suicide Severity Rating Scale (C‑SSRS); 5. Comorbid severe physical diseases (e.g., severe cardiac, hepatic, or renal insufficiency), substance abuse/dependence, or unstable psychiatric symptoms including manic episodes or psychotic symptoms, resulting in inability to comply with study procedures; 6. Unable to provide valid informed consent, or expected poor adherence to study follow‑up and operational procedures with high risk of dropout.

研究实施时间：

Study execute time：

从 From 2025-02-16 00:00:00至 To 2026-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-17 00:00:00 至 To 2026-05-04 00:00:00

干预措施：

Interventions：

组别：

rTMS联合药物治疗组

样本量：

 21

Group：

Active rTMS + Medication Group

Sample size：

干预措施：

接受 rTMS 联合常规药物治疗。rTMS 采用双侧 DLPFC 序贯刺激方案：先行左侧 DLPFC 高频刺激（10 Hz，600 脉冲），后行右侧 DLPFC 低频刺激（1 Hz，1200 脉冲），单次总脉冲数 1800 次。

干预措施代码：

Intervention：

Received rTMS combined with routine pharmacotherapy. rTMS was delivered using a sequential bilateral DLPFC protocol: high frequency stimulation over the left DLPFC (10 Hz, 600 pulses) followed by low?frequency stimulation over the right DLPFC (1 Hz, 1200 pulses), with a total of 1800 pulses per session.

Intervention code：

组别：

假rTMS联合药物治疗组

样本量：

 21

Group：

Sham rTMS + Medication Group

Sample size：

干预措施：

接受假 rTMS 联合常规药物治疗。操作流程、线圈位置、治疗时长及频次均与真 rTMS 组一致，但使用安慰剂线圈，无有效磁场输出。

干预措施代码：

Intervention：

Received sham rTMS combined with routine pharmacotherapy. The procedure, coil placement, treatment duration and frequency were identical to the active rTMS group, but a placebo coil was used without effective magnetic field output.

Intervention code：

组别：

单纯药物治疗组

样本量：

 21

Group：

Medication Only Group

Sample size：

干预措施：

不接受 rTMS 干预，仅给予标准化药物治疗及常规临床随访。

干预措施代码：

Intervention：

Received no rTMS intervention, only standardized pharmacotherapy and routine clinical follow?up.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

 晋江 

Country：

China

Province：

Fujian

City：

Jinjiang

单位(医院)：

 晋江市第三医院 

单位级别：

 二级 

Institution
hospital：

The Third Hospital of Jinjiang

Level of the institution：

Secondary

测量指标：

Outcomes：

指标中文名：

情绪调节困难量表简版

指标类型：

主要指标

Outcome：

Difficulties in Emotion Regulation Scale-16-item version, DERS-16

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

哥伦比亚自杀严重程度评定量表-自伤项目

指标类型：

主要指标

Outcome：

Columbia-Suicide Severity Rating Scale (C-SSRS) - Self-Injury Items

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

巴拉特冲动性量表-11

指标类型：

次要指标

Outcome：

Barratt Impulsiveness Scale-11-item version, BIS-11

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

汉密尔顿焦虑量表-17

指标类型：

次要指标

Outcome：

Hamilton Anxiety Rating Scale-17-item version, HAMA-17

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

汉密尔顿抑郁量表-24

指标类型：

次要指标

Outcome：

Hamilton Depression Rating Scale-24-item version, HAMD-24

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脑电事件相关电位数据

指标类型：

次要指标

Outcome：

Event-related potential data

Type：

Secondary 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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 12 岁 years
最大 Max age 18 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）：

由不参与任何临床操作与结局评估的统计学人员采用SAS 9.4软件，以是否使用SSRI药物为分层因素，通过区组随机化方法生成随机分配序列（区组长度为6）。

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

A statistician who was not involved in any clinical procedures or outcome assessments generated the random allocation sequence using SAS 9.4 software with a block randomization method (block size = 6), stratified by whether SSRIs were used.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究采用四盲设计，即参与者、法定监护人、结局评估者及统计学人员均对分组情况保持盲态。rTMS治疗师仅负责操作，不参与任何结局评估、安全性监测及数据统计工作。假刺激组采用与真刺激线圈外观、声音、重量完全一致的安慰剂线圈，操作时垂直于头皮放置，仅在刺激初始阶段输出微弱无效磁场，以保证假刺激的模拟效果。干预结束后，采用盲法完整性调查问卷开展盲法检验，若参与者对分组的正确猜测率超过30%，则采用敏感性分析验证研究结果的稳定性。

Blinding：

A four‑blind design was adopted in this study: participants, legal guardians, outcome assessors, and statisticians were all blinded to group assignment. The rTMS therapist was only responsible for treatment delivery and did not participate in any outcome assessment, safety monitoring, or data analysis. The sham stimulation group used a placebo coil with identical appearance, sound, and weight to the active coil. During administration, the coil was placed perpendicular to the scalp and delivered only a weak, ineffective magnetic field at the initial stage to ensure adequate blinding. After intervention, blinding integrity was assessed using a blinding questionnaire. If the rate of correct group guesses by participants exceeded 30%, sensitivity analysis would be performed to verify the stability of the study results.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

论文发表后1年内，通过国家生物信息中心平台（https://ngdc.cncb.ac.cn/gsub/）共享去标识化的原始研究数据，数据仅用于学术研究。

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

Within 1 year after the publication of the paper, de-identified raw study data will be shared via the National Center for Bioinformatics platform (https://ngdc.cncb.ac.cn/gsub/) for academic research purposes only.

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

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：

  2026-04-21 16:04:09
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