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Phase-Locked Accelerated Intermittent Theta Burst Stimulation for Treatment-Resistant Depression

2026年11月4日 更新者:Wei-Chung Mao、Cheng-Hsin General Hospital

Development of Precision Medicine in the Field of iTBS on Patients With TRD Using Multimodal Functional Brain Imaging and Deep Learning

This study aims to investigate whether synchronizing accelerated intermittent theta burst stimulation (aiTBS) with an individual's ongoing brain activity improves treatment outcomes in adults with Treatment-Resistant Depression (TRD).

Participants were randomly assigned to one of two treatment groups:

  1. Phase-locked aiTBS (PL-aiTBS): Magnetic stimulation was synchronized with a specific phase of ongoing brain activity measured using electroencephalography (EEG).
  2. Random-phase aiTBS (RP-aiTBS): Participants received the same stimulation protocol without synchronization to a specific phase of brain activity.

Both groups received personalized stimulation based on their individual theta frequency. Treatment consisted of 10 sessions over three consecutive days, with three sessions on Day 1, three sessions on Day 2, and four sessions on Day 3 (3-3-4 schedule). Each session delivered 1,800 magnetic pulses, resulting in a total of 18,000 pulses per participant.

The primary objective was to compare changes in depressive symptoms between the two treatment groups. Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAM-D) and the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline (before the first stimulation session), mid-treatment (after the sixth session, Day 2), post-treatment (after the tenth session, Day 3), and follow-up (Day7).

Resting-state EEG recordings were collected before and after stimulation sessions to investigate treatment-related changes in neural oscillatory activity, phase-amplitude coupling, functional connectivity, and other neurophysiological measures, as well as their potential associations with improvements in depressive symptoms.

研究概览

研究类型

介入性

注册 (实际的)

54

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。

学习地点

    • Taipei City
      • Taipei、Taipei City、台湾、112
        • Cheng Hsin General Hospital

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

18年 至 70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:

  • Adults aged 18 to 70 years.
  • Diagnosis of major depressive disorder (MDD).
  • Inadequate response to at least two antidepressant trials of adequate dose and duration.
  • A 17-item Hamilton Depression Rating Scale (HAM-D) score of 9 or higher.
  • A Montgomery-Åsberg Depression Rating Scale (MADRS) score of 16 or higher.
  • Willingness to participate in the study and provision of written informed consent.

Exclusion Criteria:

  • Other psychiatric disorders or serious medical conditions.
  • Psychotic disorders.
  • Current illicit drug use or alcohol use disorder.
  • Neurological or seizure disorders.
  • Contraindications to transcranial magnetic stimulation (TMS), including cardiac pacemakers or metallic implants.
  • Pregnancy or postpartum depression.
  • Electroconvulsive therapy (ECT) within the previous 12 months.
  • Unstable medical illness.
  • Inability to comply with study procedures.

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:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Phase-Locked Accelerated iTBS (PL-aiTBS)

Participants received individualized accelerated intermittent theta burst stimulation (aiTBS) synchronized to a specific phase of ongoing frontal theta oscillations measured using EEG.

Stimulation was delivered to the left dorsolateral prefrontal cortex (DLPFC; F3) using an individualized theta-frequency-based iTBS protocol. Each participant received 10 sessions over three consecutive days (3-3-4 schedule), with 1,800 pulses per session (18,000 pulses total). Stimulation was synchronized to the trough of ongoing frontal theta oscillations using real-time EEG phase estimation.

有源比较器:Random-Phase Accelerated iTBS (RP-aiTBS)

Participants received the same individualized aiTBS protocol without phase-locked synchronization to ongoing frontal theta oscillations.

Participants received the same individualized iTBS protocol targeting the left DLPFC (F3), consisting of 10 sessions over three consecutive days (3-3-4 schedule), with 1,800 pulses per session (18,000 pulses total). Stimulation was delivered without phase-locked synchronization to ongoing frontal theta oscillations.

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
Change in HAM-D Total Score
大体时间:Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAM-D), with total scores ranging from 0 to 52. Higher scores indicate greater depressive symptom severity. Changes in total scores from baseline were evaluated at each post-baseline assessment.

Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Change in MADRS Total Score
大体时间:Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), with total scores ranging from 0 to 60. Higher scores indicate greater depressive symptom severity. Changes in total scores from baseline were evaluated at each post-baseline assessment.

Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

次要结果测量

结果测量
措施说明
大体时间
Response Rate Based on HAM-D
大体时间:Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Treatment response was defined as a reduction of at least 50% in HAM-D total score relative to baseline. The response rate was calculated as the percentage of participants meeting this criterion at each assessment time point.

Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Response Rate Based on MADRS
大体时间:Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Treatment response was defined as a reduction of at least 50% in MADRS total score relative to baseline. The response rate was calculated as the percentage of participants meeting this criterion at each assessment time point.

Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Remission Rate Based on HAM-D17
大体时间:Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Remission was defined as a HAM-D17 total score of 7 or lower. The remission rate was calculated as the percentage of participants meeting this criterion at each assessment time point.

Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Remission Rate Based on MADRS
大体时间:Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Remission was defined as a MADRS total score of 10 or lower. The remission rate was calculated as the percentage of participants meeting this criterion at each assessment time point.

Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

其他结果措施

结果测量
措施说明
大体时间
Change From Baseline in Resting-State EEG Spectral Power
大体时间:Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Resting-state electroencephalography (EEG) was recorded to assess changes in neural oscillatory activity following accelerated intermittent theta burst stimulation (aiTBS). Spectral power was quantified across conventional frequency bands, including delta, theta, alpha, beta, and gamma. Changes in spectral power from baseline were evaluated across treatment stages.

Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Change From Baseline in Resting-State EEG Phase-Amplitude Coupling
大体时间:Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Resting-state EEG was analyzed to assess phase-amplitude coupling (PAC), reflecting the relationship between the phase of lower-frequency oscillations and the amplitude of higher-frequency activity. Changes in PAC strength from baseline were evaluated across treatment stages to characterize neurophysiological effects of aiTBS.

Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Resting-State EEG Functional Connectivity
大体时间:Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Resting-state EEG functional connectivity was assessed using phase-based synchronization measures between brain regions. Changes in functional connectivity from baseline were evaluated across treatment stages to investigate stimulation-related alterations in neural synchronization.

Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Change From Baseline in Resting-State EEG Microstate Parameters
大体时间:Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Resting-state EEG microstate analysis was used to characterize changes in the temporal dynamics of large-scale brain network activity. Microstate parameters included mean duration (ms), occurrence rate (events/s), time coverage (%), and transition probabilities between microstate classes. Changes in these parameters were evaluated across treatment sessions to investigate stimulation-related alterations in brain network dynamics.

Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

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。

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)

2024年5月22日

初级完成 (实际的)

2026年4月15日

研究完成 (实际的)

2026年4月15日

研究注册日期

首次提交

2026年11月4日

首先提交符合 QC 标准的

2026年11月4日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • (985)111A-63
  • (1126)113A-56 (其他标识符:Cheng Hsin General Hospital Institutional Review Board)

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

Individual participant data will not be shared publicly due to participant confidentiality and privacy considerations. No external IPD sharing is currently planned.

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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