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Individualized Temporal Interference Stimulation for Reward Processing in Late-Life Depression

2026年11月3日 更新者：Xiang Yang Zhang、Beijing HuiLongGuan Hospital

Neural Mechanisms Underlying the Modulation of Reward Processing by Individualized Temporal Interference Stimulation Targeting the Nucleus Accumbens in Late-Life Depression

This study aims to investigate the effects and neural mechanisms of individualized temporal interference stimulation (TI) targeting the left nucleus accumbens in older adults with depression. A total of 70 participants aged 60-80 years will be randomly assigned to receive active TI or sham stimulation. Clinical and cognitive assessments, a probabilistic reversal learning (PRL) task, MRI, and TMS-EEG will be used to evaluate changes in depressive symptoms, reward processing, and brain activity. Clinical and cognitive follow-up assessments will be conducted at 1 and 4 weeks after the intervention.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a randomized, double-blind, sham-controlled, parallel-group study involving 70 adults aged 60-80 years who meet DSM-5 criteria for a current episode of major depressive disorder and have at least moderate depressive symptoms.

Participants will be randomly assigned in a 1:1 ratio to an active TI group (n=35) or a sham stimulation group (n=35). Individualized TI will target the left nucleus accumbens, with stimulation administered for approximately 20 minutes per session, twice daily for five consecutive days (10 sessions in total).

Clinical and neuropsychological assessments will evaluate depressive symptoms, anxiety, anhedonia, sleep, and cognitive function. A probabilistic reversal learning (PRL) task will assess reward learning and cognitive flexibility. Structural MRI will support individualized stimulation planning, while resting-state functional MRI (rs-fMRI) and TMS-EEG will be used to investigate changes in brain networks and neurophysiological activity.

Assessments will be conducted at baseline and after the intervention, with additional follow-ups at 1 and 4 weeks. The study will compare changes between groups and explore associations among clinical outcomes, reward processing, and neural measures.

研究类型

介入性

注册 (估计的)

70

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

  • 姓名：Dongmei Wang, Ph.D
  • 电话号码：+86 132 4190 1959
  • 邮箱：wangdm@psych.ac.cn

学习地点

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

60年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Aged 60-80 years.
  • Meet the DSM-5 diagnostic criteria for a current episode of major depressive disorder (MDD).
  • Have at least moderate depressive symptoms.
  • Able to understand and comply with study procedures, provide written informed consent, and voluntarily participate in the study.

Exclusion Criteria:

  • History of severe neurological disorders or epilepsy.
  • Severe or unstable medical conditions.
  • Contraindications to MRI, transcranial magnetic stimulation (TMS), or transcranial electrical stimulation.
  • Comorbid severe psychiatric disorders, such as bipolar disorder or schizophrenia.
  • Significant cognitive impairment that interferes with informed consent or completion of study procedures.
  • High suicide risk.
  • Any other medical or safety condition that, in the investigator's judgment, makes participation inappropriate.

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：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Active Temporal Interference Stimulation

Participants will receive individualized active temporal interference stimulation (TI) targeting the left nucleus accumbens, for 20 minutes per session, twice daily for five consecutive days (10 sessions in total).
设备：Active Temporal Interference Stimulation

Individualized active temporal interference stimulation (TI) targeting the left nucleus accumbens, delivered for 20 minutes per session, twice daily for five consecutive days (10 sessions in total).
假比较器：Sham Temporal Interference Stimulation

Participants will receive sham temporal interference stimulation (TI) with similar electrode placement and procedures, following the same schedule as the active group (10 sessions over five days).
设备：Sham Temporal Interference Stimulation

Sham temporal interference stimulation (TI) with similar electrode placement and procedures, without sustained effective stimulation, following the same schedule as the active group (10 sessions over five days).

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
Hamilton Depression Rating Scale (HAMD-24)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

The 24-item Hamilton Depression Rating Scale (HAMD-24) assesses depressive symptom severity. Total scores range from 0 to 76, with higher scores indicating more severe depressive symptoms.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Snaith-Hamilton Pleasure Scale (SHAPS)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Anhedonia will be assessed using the 14-item Snaith-Hamilton Pleasure Scale (SHAPS). Total scores range from 14 to 56, with higher scores indicating more severe anhedonia. Changes from baseline will be compared between groups.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Probabilistic Reversal Learning (PRL) Task
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

The PRL task assesses reward-based learning and cognitive flexibility. Participants learn from probabilistic feedback and adjust their choices when reward contingencies change. Task performance will be evaluated using behavioral measures of reward learning and reversal learning.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

次要结果测量

结果测量
措施说明
大体时间
Hamilton Anxiety Rating Scale (HAMA)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Anxiety severity will be assessed using the 14-item HAMA. Total scores range from 0 to 56, with higher scores indicating more severe anxiety.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disturbances. The global score, calculated from seven components, ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Mini-Mental State Examination (MMSE)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Global cognitive function will be assessed using the MMSE. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Auditory Verbal Learning Test (AVLT) Performance
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Verbal learning and memory will be evaluated using the numbers of correctly recalled words during immediate recall, delayed recall, category-cued recall, and recognition testing.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Verbal Fluency Test (VF) Performance
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Verbal fluency will be assessed using the numbers of valid responses generated during animal naming, phonemic word generation, and action fluency tasks, each lasting one minute.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
3D Confusion Assessment Method (3D-CAM)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Delirium will be assessed using the 3-Minute Diagnostic Interview for CAM-Defined Delirium (3D-CAM). The outcome will be recorded as the presence or absence of delirium.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Clock Drawing Test (CDT)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Visuospatial and executive functioning will be assessed using a four-point Clock Drawing Test. Scores range from 0 to 4, with higher scores indicating better performance.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Digit Span Test (DST) Performance
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Attention and working memory will be assessed using forward and backward digit span, including maximum correctly recalled span length and the number of correct sequences.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Trail Making Test (TMT)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Processing speed, attention, and executive functioning will be evaluated using completion time in seconds across the four TMT conditions in the study protocol. Errors will also be recorded.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Neuropsychiatric Inventory (NPI)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

The 12-domain Neuropsychiatric Inventory (NPI) assesses neuropsychiatric symptoms. The total score is calculated by summing frequency × severity scores across 12 domains and ranges from 0 to 144, with higher scores indicating more severe symptoms.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Activities of Daily Living (ADL)
大体时间：Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups

Daily functioning will be assessed using the 20-item ADL scale. Scores range from 20 to 80, with higher scores indicating greater functional impairment.
Baseline, immediately after the intervention, and at 1-week and 4-week follow-ups
Resting-State fMRI Brain Network Measures
大体时间：Baseline, immediately after the intervention

Resting-state fMRI will be used to evaluate changes in nucleus accumbens-related functional connectivity and brain network characteristics following the intervention.
Baseline, immediately after the intervention
TMS-Evoked Global Mean Field Amplitude (GMFA)
大体时间：Baseline, immediately after the intervention

Global mean field amplitude (GMFA) will be calculated from TMS-evoked EEG recordings to quantify the overall cortical response to stimulation. Changes in GMFA amplitude will be assessed.
Baseline, immediately after the intervention
TMS-EEG Time-Frequency Power
大体时间：Baseline, immediately after the intervention

Time-frequency analysis of TMS-EEG recordings will be used to assess changes in oscillatory power across frequency bands following stimulation.
Baseline, immediately after the intervention
TMS-EEG Functional Connectivity
大体时间：Baseline, immediately after the intervention

Functional connectivity will be assessed using TMS-EEG recordings to evaluate changes in the synchronization and interaction of cortical brain regions.
Baseline, immediately after the intervention
TMS-EEG Source-Localized Cortical Activity
大体时间：Baseline, immediately after the intervention

EEG source reconstruction will be used to estimate changes in TMS-evoked cortical activity at the source level.
Baseline, immediately after the intervention
TMS-Evoked Potential (TEP) Amplitude
大体时间：Baseline, immediately after the intervention

TMS-evoked potentials (TEPs) will be analyzed to assess changes in cortical responses, including the amplitude of TMS-evoked EEG components.
Baseline, immediately after the intervention

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

Beijing HuiLongGuan Hospital

调查人员

  • 首席研究员：Xiangyang Zhang, Ph.D、Tsinghua University

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 (估计的)

2026年11月10日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年10月24日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CASPsy13

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The datasets generated and/or analyzed during the current study are not publicly available due to ethical restrictions (as they contain information that could compromise participant privacy), but will be available from the corresponding author upon reasonable request after completion of the study and approval by the ethics committee.

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

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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