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Electrophysiological Biomarkers in Accelerated TMS for Depression

2026年5月22日 更新者：Ali Tarık Altunç、Istanbul University - Cerrahpasa

Electrophysiological Biomarkers of Treatment Response in Major Depressive Disorder Patients Receiving Accelerated Transcranial Magnetic Stimulation

This study investigates whether physiological signals recorded during transcranial magnetic stimulation (TMS) can predict which patients with major depression respond to treatment. Thirty-two adults with major depressive disorder receive an accelerated TMS protocol targeting the dorsomedial prefrontal cortex using a double-cone coil, delivered as four sessions per day over five to eight days. Heart rate is continuously monitored throughout every stimulation session using a chest-strap sensor, and electroencephalography (EEG) is recorded before and after treatment. Heart-brain coupling was assessed in a separate dedicated session after the target stimulation dose was reached.The primary clinical outcome is the change in depression severity measured by the Hamilton Depression Rating Scale (HAMD-17) from baseline to post-treatment. Prespecified physiological outcomes include stimulation-evoked heart rate deceleration, resting-state EEG parameters, and heart-brain coupling metrics. The aim is to evaluate whether these electrophysiological measures index target engagement and predict antidepressant response, potentially supporting their use as functional biomarkers for personalizing accelerated TMS in depression.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

32

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

  • 土耳其（türkiye）
    • Bakırköy
      • Istanbul、Bakırköy、土耳其（türkiye）
        • Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Psychiatry Department

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18 to 65 years
  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of major depressive disorder, of at least moderate severity, confirmed by structured psychiatric interview
  • Insufficient response to at least one adequate trials of antidepressant pharmacotherapy during the current episode
  • Stable psychotropic medication regimen for at least 4 weeks prior to enrollment
  • Ability to provide written informed consent

Exclusion Criteria:

  • Cardiac arrhythmia or use of antiarrhythmic medication
  • Benzodiazepine use exceeding the equivalent of 1 mg/day lorazepam
  • Active suicidal ideation
  • Comorbid psychiatric disorders other than anxiety disorders (including bipolar disorder, psychotic disorders, substance use disorders, and primary obsessive-compulsive disorder)
  • Standard contraindications to transcranial magnetic stimulation, including history of seizure, intracranial metal implants, cochlear implants, or implanted neurostimulators
  • Pregnancy
  • Severe or unstable medical illness

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Accelerated bilateral dmPFC-iTBS with double-cone coil
Participants received accelerated bilateral intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) using a Cool DB-80 double-cone coil. Treatment consisted of four sessions per day, delivering 1,200 pulses per session (600 pulses per hemisphere, applied sequentially to left and right dmPFC), at 120% of resting motor threshold. The total course comprised 20 to 30 sessions over 5 to 8 days.
设备：Accelerated bilateral dmPFC-iTBS
Stimulation was delivered using a MagPro R30 stimulator equipped with a Cool DB-80 double-cone coil (MagVenture A/S, Farum, Denmark). The stimulation site was localized using the 25% nasion-inion scalp heuristic for dorsomedial prefrontal cortex (dmPFC) targeting. The intermittent theta-burst stimulation (iTBS) protocol consisted of triplet 50 Hz bursts repeated at 5 Hz, applied as 2-second trains with 8-second inter-train intervals. Each session delivered 600 pulses sequentially to the left and right dmPFC (1,200 pulses per session), at a target intensity of 120% of the hemisphere-specific resting motor threshold. Four sessions were delivered per day with approximately 50-minute inter-session intervals. The total treatment course was 20 sessions over 5 days, extended to 30 sessions over 8 days for partial responders.

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 Hamilton Depression Rating Scale (HAMD-17) Score
大体时间：Baseline, Day 5, and Day 8 for extended courses
Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17) at baseline and within 1 week after completion of the accelerated iTBS course. The HAMD-17 is a clinician-administered scale; scores range from 0 to 52, with higher scores indicating more severe depression. Treatment response was defined as a 50% or greater reduction from baseline HAMD-17 score, and remission as a post-treatment HAMD-17 score of 7 or lower.
Baseline, Day 5, and Day 8 for extended courses

次要结果测量

结果测量
措施说明
大体时间
Heart rate deceleration during stimulation
大体时间：Through completion of the treatment course, up to 8 days
Heart rate was continuously sampled at 1-second intervals using a Polar H10 chest strap during every stimulation session. Heart rate deceleration (HRD) was calculated as the percentage reduction from the 1-minute pre-stimulation baseline heart rate to the mean stimulation heart rate, using the formula: HRD (%) = [(HR_baseline - HR_stimulation) / HR_baseline] x 100. HRD was computed across four parameters (all left-sided sessions, all right-sided sessions, highest-intensity left-sided sessions, highest-intensity right-sided sessions) and averaged per participant. Higher values indicate greater stimulation-induced heart rate deceleration.
Through completion of the treatment course, up to 8 days
Change in Beck Depression Inventory (BDI)
大体时间：Baseline, Day 5, and Day 8 for extended courses
Beck Depression Inventory (BDI), a self-report scale; total scores range from 0 to 63, with higher scores indicating more severe depression.
Baseline, Day 5, and Day 8 for extended courses
Change in Beck Anxiety Inventory (BAI)
大体时间：Baseline, Day 5, and Day 8 for extended courses
Beck Anxiety Inventory (BAI), a self-report scale; total scores range from 0 to 63, with higher scores indicating more severe anxiety.
Baseline, Day 5, and Day 8 for extended courses
Change in Beck Scale for Suicide Ideation (BSS)
大体时间：Baseline, Day 5, and Day 8 for extended courses
Beck Scale for Suicide Ideation (BSS), a self-report scale; total scores range from 0 to 38, with higher scores indicating greater suicidal ideation.
Baseline, Day 5, and Day 8 for extended courses
Change in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR16) Total Score
大体时间：Baseline, Day 5, and Day 8 for extended courses
Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16); total scores range from 0 to 27, with higher scores indicating more severe depression.
Baseline, Day 5, and Day 8 for extended courses
Change in Clinical Global Impression - Severity (CGI-S)
大体时间：Baseline, Day 5, and Day 8 for extended courses
Clinical Global Impression - Severity (CGI-S); scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with higher scores indicating greater illness severity.
Baseline, Day 5, and Day 8 for extended courses
Hamilton Depression Rating Scale (HAMD-17) Total Score at 30-Day Follow-up
大体时间：30 days post-treatment
17-item Hamilton Depression Rating Scale (HAMD-17) assessed 30 days after completion of treatment; total scores range from 0 to 52, with higher scores indicating more severe depression.
30 days post-treatment
Resting State Quantitative EEG (qEEG) Spectral Power and Theta Cordance
大体时间：Baseline and completion of treatment (Day5 or Day8 for extended courses)
Absolute spectral power in the delta, theta, alpha, and beta frequency bands, derived from quantitative resting-state EEG (qEEG) analysis. Power was computed across standard electrode regions. Prefrontal theta cordance, a quantitative EEG measure combining absolute and relative theta-band power at prefrontal electrodes, derived from resting-state qEEG analysis.
Baseline and completion of treatment (Day5 or Day8 for extended courses)
Heart-Brain Coupling (HBC): Heart Rate Oscillation Power at the Stimulation Frequency
大体时间：Single dedicated measurement session after the target dose was reached, up to Day 8
Heart-brain coupling (HBC), a parameter quantifying the strength of stimulation-induced heart rate deceleration, computed as the mean oscillation power of cardiac rate at the frequency determined by the stimulation train interval (Dijkstra et al., 2023). HBC ranges from 0 to 1. Measurements were obtained in a dedicated session using a 10 Hz protocol (50 pulses per train, 5-second train duration, 15 trains, 11-second inter-train interval), recorded with a Polar H10 chest strap and the HeartBrainConnect application. HBC was assessed sequentially at four sites per participant: left dmPFC, left dorsolateral prefrontal cortex (DLPFC), right dmPFC and right DLPFC. For each site, stimulation began at 28% below target intensity and increased by 2% per train, yielding 15 HBC values that were averaged to produce a per-site HBC value.
Single dedicated measurement session after the target dose was reached, up to Day 8
EEG Microstate Temporal Parameters
大体时间：Baseline and completion of treatment (Day5 or Day8 for extended courses)
Temporal parameters of the canonical resting-state EEG microstate classes (A, B, C, and D), including mean duration (milliseconds), occurrence (mean appearances per second), time coverage (percentage of recording time), and transition probabilities between classes. Parameters were derived from microstate segmentation of resting-state EEG recordings.
Baseline and completion of treatment (Day5 or Day8 for extended courses)

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

Istanbul University - Cerrahpasa

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6月13日

初级完成 (实际的)

2025年3月14日

研究完成 (实际的)

2025年4月14日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 37949

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

De-identified individual-level data are not publicly available due to privacy and ethical restrictions on sensitive clinical data, but may be available from the corresponding author upon reasonable request and with appropriate ethics committee approval.

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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