ChiCTR2600124486 版本V1.0 版本创建时间2026/05/13 09:31:28 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：

 ChiCTR2600124486 

最近更新日期：

Date of Last Refreshed on：

 2026-05-13 09:31:21 

注册时间：

Date of Registration：

 2026-05-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经颅时域干涉刺激对难治性抑郁和慢性失眠障碍的干预研究

Public title：

Transcranial temporal interference stimulation for treatment-resistant depression and chronic insomnia disorder

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经颅时域干涉刺激对难治性抑郁和慢性失眠障碍的干预研究

Scientific title：

Transcranial temporal interference stimulation for treatment-resistant depression and chronic insomnia disorder

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：

王紫薇 

研究负责人：

杨渊 

Applicant：

Ziwei Wang 

Study leader：

Yuan Yang 

申请注册联系人电话：

Applicant telephone：

 +86 182 3635 6870

研究负责人电话：

Study leader's
telephone：

+86 139 9556 1816

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：

 wangzway@126.com

研究负责人电子邮件：

Study leader's E-mail：

 yuanyang70@hotmail.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：

中国湖北省武汉市硚口区解放大道1095号

研究负责人通讯地址：

中国湖北省武汉市硚口区解放大道1095号

Applicant address：

1095 Jiefang Dadao, Qiaokou District, Wuhan, Hubei, China

Study leader's address：

1095 Jiefang Dadao, Qiaokou District, Wuhan, Hubei, 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：

华中科技大学同济医学院附属同济医院

Applicant's institution：

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究负责人所在单位：

华中科技大学同济医学院附属同济医院

Affiliation of the Leader：

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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：

 TJ-IRB202603100

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：

华中科技大学同济医学院附属同济医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-25 00:00:00

伦理委员会联系人：

杜艾烨

Contact Name of the ethic committee：

Aiye Du

伦理委员会联系地址：

中国湖北省武汉市硚口区解放大道1095号

Contact Address of the ethic committee：

1095 Jiefang Dadao, Qiaokou District, Wuhan, Hubei, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 8366 2379

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 tongjihlunli@163.com

研究实施负责（组长）单位：

华中科技大学同济医学院附属同济医院

Primary sponsor：

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

中国湖北省武汉市硚口区解放大道1095号

Primary sponsor's address：

1095 Jiefang Dadao, Qiaokou District, Wuhan, Hubei, 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)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

华中科技大学同济医学院附属同济医院

具体地址：

中国湖北省武汉市硚口区解放大道1095号

Institution
hospital：

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address：

1095 Jiefang Dadao, Qiaokou District, Wuhan, Hubei, China

经费或物资来源：

本研究目前暂无专项经费资助。研究实施依托研究团队及所在单位现有科研条件。后续如涉及相关经费支持，将在研究报告或论文发表中根据实际情况予以说明。

Source(s) of funding：

This study currently has no dedicated research funding. The study is conducted based on the existing research conditions of the research team and institution. If relevant funding support is involved subsequently, it will be described in the study report or publication as appropriate.

研究疾病：

难治性抑郁障碍，慢性失眠障碍  

Target disease：

Treatment-resistant depression, chronic insomnia disorder

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.评估经颅TI刺激对TRD与慢性失眠障碍的干预效果，初步验证该技术的安全性与临床可行性。 2.探讨经颅TI刺激对脑电生理活动的调控机制，重点分析其对睡眠相关神经节律的影响，并进一步评估脑电变化与症状改善之间的关联。 3.区分TI刺激对慢性失眠障碍的直接调节作用与通过抗抑郁的间接作用，通过比较TRD患者与慢性失眠障碍患者的治疗反应模式，明确TI改善睡眠的作用机制，探索两者在病理生理层面上的相互作用与共同基础。  

Objectives of Study：

1. To evaluate the intervention effects of transcranial temporal interference stimulation on treatment-resistant depression and chronic insomnia disorder, and to preliminarily verify the safety and clinical feasibility of this technique. 2. To explore the modulatory mechanisms of transcranial temporal interference stimulation on electrophysiological brain activity, with a particular focus on its effects on sleep-related neural rhythms, and to further assess the associations between electroencephalographic changes and symptom improvement. 3. To distinguish the direct regulatory effects of temporal interference stimulation on chronic insomnia disorder from its indirect effects mediated by antidepressant effects. By comparing the treatment response patterns between patients with treatment-resistant depression and those with chronic insomnia disorder, this study aims to clarify the mechanism by which temporal interference stimulation improves sleep and to explore the interaction and shared pathophysiological basis between depression and insomnia.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

本研究包括两个研究队列，分别为队列1（TRD队列，难治性抑郁）和队列2（慢性失眠队列）。各队列纳入标准如下： 队列1：TRD队列（难治性抑郁） （1）年龄在18至65岁之间。 （2）具有初中及以上文化程度，具备基本的理解与配合能力，能够理解研究目的并完成相关评估与干预流程。 （3）符合《精神障碍诊断与统计手册》第五版（DSM-5）中重性抑郁障碍（Major Depressive Disorder, MDD）的诊断标准，满足TRD的诊断标准：在至少两种足量足疗程的抗抑郁药物治疗后疗效不佳，汉密尔顿抑郁量表17项（HAMD-17）评分≥17。 （4）研究前药物治疗方案已稳定≥4周（药物种类与剂量稳定），且受试者同意在研究干预期间不新增或调整药物治疗，医学必要情况下除外。 （5）病程要求：当前抑郁发作持续≥8周。 （6）签署知情同意书。 队列2：慢性失眠队列 （1）年龄18–65岁。 （2）符合ICSD-3中慢性失眠障碍的诊断标准：失眠症状持续时间≥3个月，且每周≥3晚出现以下任一症状：入睡困难、睡眠维持困难或早醒，伴有日间功能损害。睡眠障碍严重度以匹兹堡睡眠质量指数（PSQI）总分＞7为入组阈值。 （3）入组前的助眠或精神科相关药物治疗方案已稳定≥4周（药物种类和剂量未变），并同意在干预期间原则上不进行药物调整，除非出于医学必要。 （4）签署知情同意书。

Inclusion criteria

This study includes two study cohorts: Cohort 1, the treatment-resistant depression (TRD) cohort, and Cohort 2, the chronic insomnia cohort. The inclusion criteria for each cohort are as follows: Cohort 1: TRD Cohort (Treatment-Resistant Depression) (1) Aged between 18 and 65 years. (2) Having a junior high school education or above, with basic comprehension and cooperation abilities, and able to understand the study purpose and complete the relevant assessments and intervention procedures. (3) Meeting the diagnostic criteria for major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and meeting the diagnostic criteria for TRD: poor response after at least two antidepressant treatments of adequate dose and duration, with a 17-item Hamilton Depression Rating Scale (HAMD-17) score >=17. (4) Having a stable medication regimen for >=4 weeks before the study (stable medication type and dosage), and agreeing not to initiate or adjust medication treatment during the study intervention period, except when medically necessary. (5) Disease course requirement: the current depressive episode has lasted for ≥8 weeks. (6) Providing signed informed consent. Cohort 2: Chronic Insomnia Cohort (1) Aged 18–65 years. (2) Meeting the diagnostic criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders, Third Edition (ICSD-3): insomnia symptoms lasting for >=3 months, with any of the following symptoms occurring on ≥3 nights per week: difficulty initiating sleep, difficulty maintaining sleep, or early morning awakening, accompanied by daytime functional impairment. Sleep disturbance severity will be defined by a Pittsburgh Sleep Quality Index (PSQI) total score >7 as the enrollment threshold. (3) Having a stable regimen of sleep-aid or psychiatric-related medications for >=4 weeks before enrollment (unchanged medication type and dosage), and agreeing in principle not to adjust medication during the intervention period unless medically necessary. (4) Providing signed informed consent.

排除标准：

排除标准 本研究包括两个研究队列，分别为队列1（TRD队列，难治性抑郁）和队列2（慢性失眠队列）。各队列排除标准如下： 队列1：TRD队列（难治性抑郁） （1）合并其他主要精神障碍者（如精神活性物质使用障碍、精神分裂症、双相障碍等），或存在明显自杀高风险、需急诊干预者不予纳入；如合并焦虑障碍、强迫障碍等非主要临床问题，且病情稳定者，可酌情纳入。 （2）存在可能干扰神经调控安全性的器械植入或金属物，如头颅或头颈部的金属植入物（如动脉夹、金属板、金属钉、深部脑刺激电极等），体内植入心脏起搏器、除颤器或其他有源电子医疗设备。 （3）有可能影响脑电或神经功能的重大神经系统疾病史，如癫痫、脑血管意外（脑梗死/脑出血）、重度颅脑外伤史、颅脑手术史等；或存在明显颅骨缺损、颅脑外伤后遗症。 （4）合并严重躯体疾病，如冠心病、严重心律失常、慢性阻塞性肺疾病、严重肝肾功能不全等，可能干扰干预安全性或研究结果判定者。 （5）妊娠期、哺乳期或近期计划妊娠的女性（因TI的安全性尚未在该人群中确定）。 （6）近3个月内接受过其他形式的电刺激治疗者。 队列2：慢性失眠队列 （1）当前重性抑郁发作或难治性抑郁障碍（TRD）：符合DSM-5标准的当前重性抑郁障碍发作者，或符合难治性抑郁障碍（TRD）定义者予以排除；存在明显抑郁症状者亦予以排除（HAMD-17得分＞7）。 （2）其他原发睡眠障碍：中重度阻塞性睡眠呼吸暂停、不宁腿综合征/周期性肢体运动障碍、发作性睡病、REM睡眠行为障碍、昼夜节律睡眠-觉醒障碍为主因者。 （3）严重精神障碍、精神病性状态或高风险精神状态：合并双相障碍、精神分裂谱系障碍，或当前存在精神病性症状者；以及当前物质使用障碍或酒精使用障碍者；存在明显自杀高风险，或评估认为需急诊干预者。允许轻微焦虑症状存在，但排除当前主要焦虑障碍或严重焦虑状态。 （4）神经系统/癫痫风险：癫痫史或不明原因抽搐史；颅内占位、严重脑外伤后遗症等。 （5）植入物/电子设备禁忌：颅内金属植入、心脏起搏器/ICD等。 （6）妊娠与哺乳：妊娠、哺乳或近期计划妊娠。 （7）严重躯体疾病不稳定/影响睡眠的内科病未控制。 （8）近期神经调控治疗：近1个月接受rTMS/tDCS/ECT等者。

Exclusion criteria：

This study includes two study cohorts: Cohort 1, the treatment-resistant depression (TRD) cohort, and Cohort 2, the chronic insomnia cohort. The exclusion criteria for each cohort are as follows: Cohort 1: TRD Cohort (Treatment-Resistant Depression) (1) Participants with other major psychiatric disorders, such as psychoactive substance use disorder, schizophrenia, bipolar disorder, or those with obvious high suicide risk requiring emergency intervention, will not be included. Participants with non-primary clinical problems such as anxiety disorders or obsessive-compulsive disorder may be considered for inclusion if their condition is stable. (2) Participants with implanted devices or metallic objects that may interfere with the safety of neuromodulation, such as metallic implants in the head or head-and-neck region, including aneurysm clips, metal plates, metal nails, deep brain stimulation electrodes, or implanted cardiac pacemakers, defibrillators, or other active electronic medical devices. (3) Participants with a history of major neurological diseases that may affect electroencephalographic activity or neurological function, such as epilepsy, cerebrovascular accidents, including cerebral infarction or cerebral hemorrhage, severe traumatic brain injury, or craniocerebral surgery; or those with obvious skull defects or sequelae of traumatic brain injury. (4) Participants with severe physical diseases, such as coronary heart disease, severe arrhythmia, chronic obstructive pulmonary disease, or severe hepatic or renal dysfunction, that may interfere with the safety of the intervention or the interpretation of study results. (5) Women who are pregnant, breastfeeding, or planning to become pregnant in the near future, because the safety of TI stimulation has not yet been established in this population. (6) Participants who have received other forms of electrical stimulation therapy within the past 3 months. Cohort 2: Chronic Insomnia Cohort (1) Current major depressive episode or treatment-resistant depression (TRD): participants who meet the DSM-5 criteria for a current major depressive episode, or who meet the definition of treatment-resistant depression (TRD), will be excluded; participants with obvious depressive symptoms will also be excluded (HAMD-17 score >7). (2) Other primary sleep disorders: participants whose main condition is moderate-to-severe obstructive sleep apnea, restless legs syndrome/periodic limb movement disorder, narcolepsy, REM sleep behavior disorder, or circadian rhythm sleep-wake disorder. (3) Severe psychiatric disorders, psychotic states, or high-risk psychiatric conditions: participants with bipolar disorder, schizophrenia spectrum disorders, or current psychotic symptoms; those with current substance use disorder or alcohol use disorder; and those with obvious high suicide risk or who are assessed as requiring emergency intervention. Mild anxiety symptoms are allowed, but current primary anxiety disorders or severe anxiety states will be excluded. (4) Neurological disease or epilepsy risk: history of epilepsy or unexplained seizures; intracranial space-occupying lesions; severe sequelae of traumatic brain injury; and other similar conditions. (5) Contraindications related to implants or electronic devices: intracranial metallic implants, cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), and other similar devices. (6) Pregnancy and breastfeeding: pregnancy, breastfeeding, or planning to become pregnant in the near future. (7) Severe or unstable physical diseases, or uncontrolled medical conditions that may affect sleep. (8) Recent neuromodulation treatment: receipt of rTMS, tDCS, ECT, or other similar treatments within the past 1 month.

研究实施时间：

Study execute time：

从 From 2026-05-31 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-10 00:00:00 至 To 2027-04-01 00:00:00

干预措施：

Interventions：

组别：

TRD真刺激组

样本量：

 20

Group：

TRD active TI stimulation group

Sample size：

干预措施：

接受经颅时域干涉刺激（TI）真刺激。刺激靶点为双侧胼胝体下扣带回（SCC）。干预为连续7天、每日2次、每次20分钟，共14次刺激；两次刺激间隔≥6小时。干预期间监测安全性及依从性，并记录主观不适与不良事件。

干预措施代码：

Intervention：

Participants receive active transcranial temporal interference stimulation targeting the bilateral subcallosal cingulate cortex. The intervention is delivered for 7 consecutive days, twice daily with an interval of ≥6 hours, 20 minutes per session, for a total of 14 sessions. Safety, adherence, subjective discomfort, and adverse events are monitored during the intervention.

Intervention code：

组别：

TRD对照组

样本量：

 20

Group：

TRD control stimulation group

Sample size：

干预措施：

接受外观一致但无真实电刺激输出的对照刺激。干预为连续7天、每日2次、每次20分钟，共14次；两次刺激间隔≥6小时。干预流程、设备外观及操作方式与真刺激组保持一致，以维持盲法。

干预措施代码：

Intervention：

Participants receive control stimulation with the same appearance and procedure as the active stimulation condition but without real electrical stimulation output. The intervention is delivered for 7 consecutive days, twice daily with an interval of ≥6 hours, 20 minutes per session, for a total of 14 sessions. The procedure, device appearance, and operation are kept consistent with the active stimulation group to maintain blinding.

Intervention code：

组别：

慢性失眠真刺激组

样本量：

 20

Group：

Chronic insomnia active TI stimulation group

Sample size：

干预措施：

接受经颅时域干涉刺激（TI）真刺激。刺激靶点为双侧胼胝体下扣带回（SCC）。干预为连续7天、每日2次、每次20分钟，共14次刺激；两次刺激间隔≥6小时。干预期间监测安全性及依从性，并记录主观不适与不良事件。

干预措施代码：

Intervention：

Participants receive active transcranial temporal interference stimulation targeting the bilateral subcallosal cingulate cortex. The intervention is delivered for 7 consecutive days, twice daily with an interval of ≥6 hours, 20 minutes per session, for a total of 14 sessions. Safety, adherence, subjective discomfort, and adverse events are monitored during the intervention.

Intervention code：

组别：

慢性失眠对照组

样本量：

 20

Group：

Chronic insomnia control stimulation group

Sample size：

干预措施：

接受外观一致但无真实电刺激输出的对照刺激。干预为连续7天、每日2次、每次20分钟，共14次；两次刺激间隔≥6小时。干预流程、设备外观及操作方式与真刺激组保持一致，以维持盲法。

干预措施代码：

Intervention：

Participants receive control stimulation with the same appearance and procedure as the active stimulation condition but without real electrical stimulation output. The intervention is delivered for 7 consecutive days, twice daily with an interval of ≥6 hours, 20 minutes per session, for a total of 14 sessions. The procedure, device appearance, and operation are kept consistent with the active stimulation group to maintain blinding.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

 武汉 

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

 华中科技大学同济医学院附属同济医院 

单位级别：

 三甲 

Institution
hospital：

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

HAMD-17评分变化（TRD队列）

指标类型：

主要指标

Outcome：

Change in HAMD-17 score (TRD cohort)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PSQI评分变化（慢性失眠队列）

指标类型：

主要指标

Outcome：

Change in PSQI score (chronic insomnia cohort)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

蒙哥马利-阿斯伯格抑郁量表（MADRS）评分

指标类型：

次要指标

Outcome：

Montgomery–?sberg Depression Rating Scale (MADRS) score

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（HAMA）评分

指标类型：

次要指标

Outcome：

Hamilton Anxiety Rating Scale (HAMA) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

失眠严重度指数（ISI）评分

指标类型：

次要指标

Outcome：

Insomnia Severity Index (ISI) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

躯体化症状自评量表（PHQ-15）评分

指标类型：

次要指标

Outcome：

Patient Health Questionnaire-15 (PHQ-15) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疲劳量表-14（FS-14）评分

指标类型：

次要指标

Outcome：

Fatigue Scale-14 (FS-14) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

快感体验量表（SHAPS）评分

指标类型：

次要指标

Outcome：

Snaith-Hamilton Pleasure Scale (SHAPS) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

反刍思维量表（RRS）评分

指标类型：

次要指标

Outcome：

Ruminative Responses Scale (RRS) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

状态-特质焦虑问卷（STAI）评分

指标类型：

次要指标

Outcome：

State-Trait Anxiety Inventory (STAI) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

感知压力量表（PSS）评分

指标类型：

次要指标

Outcome：

Perceived Stress Scale (PSS) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

社会功能缺陷筛选量表（SDSS）评分

指标类型：

次要指标

Outcome：

Social Disability Screening Schedule (SDSS) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脑电图指标

指标类型：

次要指标

Outcome：

Electroencephalographic indicators

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

事件相关电位指标

指标类型：

次要指标

Outcome：

Event-related potential indicators

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

多导睡眠监测指标（慢性失眠队列）

指标类型：

次要指标

Outcome：

Polysomnography indicators (chronic insomnia cohort)

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：

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 65 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）：

本研究采用分层区组随机化方法。由不参与受试者招募、干预实施及结局评估的独立研究人员使用R语言生成随机序列。随机化按研究队列分层，即TRD队列和慢性失眠障碍队列；在各队列内以1:1比例将受试者随机分配至TI真刺激组或对照组。随机序列由独立研究人员保存，以保证分配隐藏。

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

A stratified block randomization method will be used. An independent researcher who is not involved in participant recruitment, intervention delivery, or outcome assessment will generate the randomization sequence using R software. Randomization will be stratified by study cohort, namely the TRD cohort and the chronic insomnia disorder cohort. Within each cohort, participants will be randomly assigned in a 1:1 ratio to the active TI stimulation group or the control group. The randomization sequence will be kept by the independent researcher to ensure allocation concealment.

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：

本研究采用双盲设计。受试者与结局评估人员均不知晓分组情况。TI真刺激组与对照组的刺激程序外观一致、操作流程相同，由不参与结局评估和数据分析的指定技术人员根据分组代码完成刺激参数设置和设备操作。研究过程中，招募人员、结局评估人员和受试者均不接触分组代码。

Blinding：

This study will use a double-blind design. Participants and outcome assessors will remain unaware of group allocation. The active TI stimulation group and the control group will receive procedures with the same appearance and operation process. Stimulation parameters and device operation will be managed by designated technical personnel who are not involved in outcome assessment or data analysis, according to the allocation code. During the study, recruiters, outcome assessors, and participants will not have access to the allocation code.

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

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）：

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：

本研究采用病例报告表（CRF）及电子数据表进行数据采集和管理。所有数据由经过培训的研究人员按照标准操作流程采集，并采用受试者编号进行去标识化管理。纸质资料由专人保存在加锁文件柜中，电子数据存储于密码保护的研究电脑或加密存储设备中，仅限授权研究人员访问。数据录入后由两名研究人员进行核查，以确保数据完整性和准确性。

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

Data will be collected and managed using case report forms (CRFs) and electronic data sheets. All data will be collected by trained researchers according to standard operating procedures and managed using coded participant identifiers after de-identification. Paper documents will be stored in locked cabinets, and electronic data will be stored on password-protected research computers or encrypted storage devices. Access will be restricted to authorized research personnel only. Data will be checked by two researchers after entry to ensure completeness and accuracy.

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：

  2026-05-13 09:31:21