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.
調査の概要
研究の種類
介入
入学 (実際)
32
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Bakırköy
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Istanbul、Bakırköy、トルコ（Türkiye）
- Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Psychiatry Department
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Hamilton Depression Rating Scale (HAMD-17) Score
時間枠：Baseline, Day 5, and Day 8 for extended courses
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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.
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Baseline, Day 5, and Day 8 for extended courses
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Heart rate deceleration during stimulation
時間枠：Through completion of the treatment course, up to 8 days
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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.
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Through completion of the treatment course, up to 8 days
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Change in Beck Depression Inventory (BDI)
時間枠：Baseline, Day 5, and Day 8 for extended courses
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Beck Depression Inventory (BDI), a self-report scale; total scores range from 0 to 63, with higher scores indicating more severe depression.
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Baseline, Day 5, and Day 8 for extended courses
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Change in Beck Anxiety Inventory (BAI)
時間枠：Baseline, Day 5, and Day 8 for extended courses
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Beck Anxiety Inventory (BAI), a self-report scale; total scores range from 0 to 63, with higher scores indicating more severe anxiety.
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Baseline, Day 5, and Day 8 for extended courses
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Change in Beck Scale for Suicide Ideation (BSS)
時間枠：Baseline, Day 5, and Day 8 for extended courses
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Beck Scale for Suicide Ideation (BSS), a self-report scale; total scores range from 0 to 38, with higher scores indicating greater suicidal ideation.
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Baseline, Day 5, and Day 8 for extended courses
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Change in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR16) Total Score
時間枠：Baseline, Day 5, and Day 8 for extended courses
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Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16); total scores range from 0 to 27, with higher scores indicating more severe depression.
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Baseline, Day 5, and Day 8 for extended courses
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Change in Clinical Global Impression - Severity (CGI-S)
時間枠：Baseline, Day 5, and Day 8 for extended courses
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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.
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Baseline, Day 5, and Day 8 for extended courses
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Hamilton Depression Rating Scale (HAMD-17) Total Score at 30-Day Follow-up
時間枠：30 days post-treatment
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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.
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30 days post-treatment
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Resting State Quantitative EEG (qEEG) Spectral Power and Theta Cordance
時間枠：Baseline and completion of treatment (Day5 or Day8 for extended courses)
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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.
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Baseline and completion of treatment (Day5 or Day8 for extended courses)
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Heart-Brain Coupling (HBC): Heart Rate Oscillation Power at the Stimulation Frequency
時間枠：Single dedicated measurement session after the target dose was reached, up to Day 8
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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.
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Single dedicated measurement session after the target dose was reached, up to Day 8
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EEG Microstate Temporal Parameters
時間枠：Baseline and completion of treatment (Day5 or Day8 for extended courses)
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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.
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Baseline and completion of treatment (Day5 or Day8 for extended courses)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年6月13日
一次修了 (実際)
2025年3月14日
研究の完了 (実際)
2025年4月14日
試験登録日
最初に提出
2026年5月18日
QC基準を満たした最初の提出物
2026年5月22日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月29日
QC基準を満たした最後の更新が送信されました
2026年5月22日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 37949
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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Accelerated bilateral dmPFC-iTBSの臨床試験
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The University of Texas Health Science Center,...完了
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The University of Texas Health Science Center,...National Institute on Drug Abuse (NIDA)募集