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Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM) (TMS CBM)

2026年6月4日 更新者：Richard Liu、The University of Hong Kong

The goal of this study is to learn whether combining repetitive transcranial magnetic stimulation (rTMS) with a computerized behavioral intervention (imagery cognitive bias modification, CBM-I) reduces negative interpretation bias and mild-to-moderate depressive symptoms. The study will also examine neural changes in the dorsolateral prefrontal cortex (DLPFC) and whether timing of interventions affects outcomes.

The main questions it aims to answer are:

Does active TMS reduce negative interpretation bias and depressive symptoms more than sham TMS? Is delivering CBM-I concurrently with TMS more effective than delivering it consecutively (separate sessions) at reducing negative bias and depressive symptoms? Do combined rTMS + CBM-I approaches produce greater neural changes and improved cognitive control over self-referential interpretation than controls? Researchers will compare active TMS versus sham TMS, and concurrent versus consecutive delivery of CBM-I, to test effects on negative bias and depressive symptoms.

Participants will:

Receive either active rTMS or sham TMS targeting the DLPFC Complete imagery CBM-I sessions either concurrently with TMS or in separate (consecutive) sessions Undergo assessments of negative interpretation bias, depressive symptoms, and neural measures before and after the intervention

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

180

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 香港
    • Hong Kong Island
      • Quarry Bay、Hong Kong Island、香港
        • 招聘中
        • InnoCentre of Clinical Neuropsychology, The University of Hong Kong
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged 18 years or above
  • Right-handed
  • Normal or corrected hearing and vision
  • Obtained primary education or above
  • Able to fluently read and understand Chinese
  • Beck's Depression Inventory-II (BDI-II) score ranging from 14-28

Exclusion Criteria:

  • History of severe physical disease, brain organic diseases, and neurological disorders (e.g., dementia, brain injury, stroke, epilepsy, Parkinson's disease)
  • History of substance use/ dependence/ withdrawal
  • Participants with intellectual disability based on IQ scores
  • Participants with contraindications for rTMS such as foreign metal bodies, implant devices (cochlear implants) or history (personal or family) of seizure
  • Participants who are not suitable to be scanned by magnetic resonance imaging (MRI) machine (e.g., claustrophobic, pregnant, metal in the body, hearing aids)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：CC-R-CBM
Concurrent, Real TMS, CBM
设备：TMS
The rTMS group will receive 10 Hz stimulation to the left DLPFC at an intensity of 120% of the resting motor threshold of the right abductor pollicis brevis (APB) muscle with 4 sec trains and 11 sec intertrain intervals for 3000 pulses.Specifically in our study, we combine both intervention, but applying them concurrently and consecutively between groups.
行为的：Cognitive Bias Modification
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation. Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
假比较器：CC-S-CBM
Concurrent, Sham TMS, CBM
行为的：Cognitive Bias Modification
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation. Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
设备：Sham TMS
The TMS coil will be rotated 90 degrees, and will not be delivering active stimulation to the participant. The intensity will be set to 30 and the TMS device will be active, generating enough sound effect but no real stimulation for sham control.
有源比较器：CS-R-CBM
Consecutive, Real TMS, CBM
设备：TMS
The rTMS group will receive 10 Hz stimulation to the left DLPFC at an intensity of 120% of the resting motor threshold of the right abductor pollicis brevis (APB) muscle with 4 sec trains and 11 sec intertrain intervals for 3000 pulses.Specifically in our study, we combine both intervention, but applying them concurrently and consecutively between groups.
行为的：Cognitive Bias Modification
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation. Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Cognitive Bias
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Self-Referent Encoding Task Tool: PsychoPy Unit:Self-Referential Bias Index measured by positive and negative self-description affirmation
"From enrollment to the end of treatment at 4 weeks"
Depressive Symptoms
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Beck's Depressive Inventory-II Tool: Qualtrics Questionnaire Unit:Beck's Depressive Inventory-II Index
"From enrollment to the end of treatment at 4 weeks"
Resting State functional MRI
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: resting-state functional MRI Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: functional dicom images
"From enrollment to the end of treatment at 4 weeks"

次要结果测量

结果测量
措施说明
大体时间
Subjective Well Being
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Subjective Well-Being Scale Tool: Qualtrics Questionnaire Unit: Subjective Well-Being Index
"From enrollment to the end of treatment at 4 weeks"
Sleep Quality
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Pittsburgh Sleep Quality Index (PSQI) Tool: Qualtrics Questionnaire Unit: Sleep Quality Index
"From enrollment to the end of treatment at 4 weeks"
Anxiety Symptoms
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Beck Anxiety Inventory Task Tool: Qualtrics Questionnaire Unit: Anxiety Index
"From enrollment to the end of treatment at 4 weeks"
Structural MRI
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: T1 Structural MRI Brain Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: structural dicom images
"From enrollment to the end of treatment at 4 weeks"
Rumination Symptoms
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Rumination Response Scale (RRS) Task Tool: Qualtrics Questionnaire Unit: Rumination Index
"From enrollment to the end of treatment at 4 weeks"
Anhedonia Symptoms
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Dimensional Anhedonia Rating Scale Tool: Qualtrics Questionnaire Unit: Anhedonia Index
"From enrollment to the end of treatment at 4 weeks"
Cognitive Measures-Attention
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Reaction Time
"From enrollment to the end of treatment at 4 weeks"
Cognitive Measures-Attention
大体时间："From enrollment to the end of treatment at 4 weeks"
Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Correct Responses and Error responses will be used to calculate a performance index of sustained attention
"From enrollment to the end of treatment at 4 weeks"

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Hong Kong

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月24日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • EA230645

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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