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Context-Guided Personalized iTBS for Depression

2026年8月3日 更新者：Zhi Yang、Capital Medical University

Research on Intelligent Optimization of Neuromodulation for Depression Based on Contextual Neuroimaging

The goal of this randomized clinical trial is to learn whether context-guided personalized intermittent theta burst stimulation (iTBS) works better than standard iTBS for adults with major depressive disorder. iTBS is a noninvasive treatment that uses magnetic pulses to stimulate specific areas of the brain.

Participants will be assigned by chance to one of two treatment groups. The standard treatment group will receive iTBS at a commonly used target in the left dorsolateral prefrontal cortex after watching a neutral video. The personalized treatment group will receive iTBS at an individual brain target selected using magnetic resonance imaging data. Before each treatment session, participants in this group will watch a positive emotional video intended to activate brain functions related to the selected target.

Both groups will receive five iTBS sessions per day for five consecutive treatment days. Participants will continue their stable antidepressant treatment during the study.

The main question is whether context-guided personalized iTBS results in a higher treatment response rate than standard iTBS two weeks after treatment. Treatment response is defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale score.

Researchers will also compare early changes in depression, anxiety and other clinical symptoms, changes in brain imaging measures, and any side effects. Clinical and brain imaging assessments will be conducted before and after the treatment course, and clinical symptoms will be assessed again two weeks after treatment.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

60

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。

研究連絡先

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100088
        • Beijing Anding Hospital, Capital Medical University
        • コンタクト：

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Male or female outpatients or inpatients aged 18 to 55 years, inclusive.
  • Right-handed.
  • Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed using the Mini International Neuropsychiatric Interview (MINI). Both first and recurrent depressive episodes are eligible.
  • A 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 14 at both screening and baseline.
  • At enrollment, participants may be antidepressant-free or may have received an antidepressant at no less than the minimum effective dose for at least 4 weeks. The antidepressant may be combined with no more than two other medications, and the type and dosage of medications must remain unchanged from enrollment until study completion.
  • At least primary school education and able to understand the study procedures and requirements.
  • Able to undergo magnetic resonance imaging and intermittent theta burst stimulation safely.
  • Voluntarily agrees to participate and provides written informed consent.

Exclusion Criteria:

  • Serious or unstable medical or neurological illness.
  • Pregnancy or breastfeeding.
  • History of seizure, epilepsy, hydrocephalus, or central nervous system tumor.
  • Contraindication to magnetic resonance imaging, including claustrophobia, an electronic or metallic implant, or a non-removable metallic dental prosthesis.
  • Receipt of systematic modified electroconvulsive therapy, transcranial magnetic stimulation, deep brain stimulation, vagus nerve stimulation, or another physical neuromodulation treatment within 3 months before screening.
  • Excessive head motion during MRI scanning (rotation exceeding 3.0° and/or translation exceeding 3 mm)
  • Resting motor threshold remaining at or above 70% of the device maximum stimulator output after repeated testing, when the investigator considers continued treatment to present a safety concern.

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：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Context-Guided Personalized iTBS
Participants assigned to this arm will receive context-guided personalized intermittent theta burst stimulation (iTBS). An individualized stimulation target in the left or right dorsolateral prefrontal cortex will be selected based on the participant's functional magnetic resonance imaging data. Before each iTBS session, participants will watch a positive emotional video intended to engage the brain functions related to the individualized target. Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold.
デバイス：Context-Guided Personalized Intermittent Theta Burst Stimulation
An individualized stimulation target in the left or right dorsolateral prefrontal cortex is selected using the participant's functional magnetic resonance imaging data. Before each stimulation session, the participant watches a positive emotional video intended to engage brain functions related to the selected target. Intermittent theta burst stimulation is delivered at 100% of the resting motor threshold. Each session delivers 1,800 pulses over approximately 10 minutes. Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
アクティブコンパレータ：Standard Left DLPFC iTBS
Participants assigned to this arm will receive standard intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. Before each iTBS session, participants will watch a neutral video. Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold.
デバイス：Standard Left DLPFC Intermittent Theta Burst Stimulation
Intermittent theta burst stimulation is delivered to a standard treatment target in the left dorsolateral prefrontal cortex. Before each stimulation session, the participant watches a neutral video. Stimulation is delivered at 100% of the resting motor threshold. Each session delivers 1,800 pulses over approximately 10 minutes. Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.

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
Treatment Response Rate at 2-Week Follow-up Based on HAMD-17
時間枠：At 2 weeks after completion of treatment (Day 21 ± 2 days).
The treatment response rate is defined as the proportion of participants with a reduction of at least 50% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) at the 2-week follow-up. The HAMD-17 is a clinician-rated scale used to assess the severity of depressive symptoms, with lower scores indicating fewer depressive symptoms. Treatment response rates will be compared between the context-guided personalized iTBS arm and the standard left DLPFC iTBS arm. The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
At 2 weeks after completion of treatment (Day 21 ± 2 days).

二次結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Adverse Events
時間枠：From the first treatment session through the 2-week follow-up after completion of treatment
The number and proportion of participants experiencing one or more adverse events will be recorded for each treatment arm. Adverse events may include headache, scalp discomfort, muscle twitching, transient mood changes, or other adverse events occurring during the treatment and follow-up periods.
From the first treatment session through the 2-week follow-up after completion of treatment
Early Treatment Response Rate Based on HAMD-17
時間枠：Baseline to immediately after completion of the treatment intervention
Early treatment response is defined as a reduction of at least 20% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) immediately after completion of the treatment intervention. The outcome will be summarized as the proportion of participants meeting this response criterion in each treatment arm. Lower HAMD-17 scores indicate fewer depressive symptoms. The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
Baseline to immediately after completion of the treatment intervention
Change From Baseline in HAMD-17 Factor Scores
時間枠：Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Changes from baseline in the prespecified factor scores of the 17-item Hamilton Depression Rating Scale (HAMD-17) will be assessed at the 2-week follow-up. For each factor, the change score will be calculated as the follow-up score minus the baseline score. A greater reduction indicates greater improvement in the corresponding depressive symptom domain. The HAMD-17 consists of 17 items; 9 items are scored from 0 to 4 and 8 items are scored from 0 to 2. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change is calculated as the post-baseline score minus the baseline score; negative values indicate improvement.
Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Change From Baseline in QIDS-SR16 Total Score
時間枠：Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Changes from baseline in the total score of the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up. Lower scores indicate fewer self-reported depressive symptoms. The QIDS-SR16 total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Change From Baseline in HAMA Total Score
時間枠：Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Changes from baseline in the total score of the Hamilton Anxiety Rating Scale (HAMA) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up. The HAMA is a clinician-rated measure of anxiety symptom severity, with lower scores indicating fewer anxiety symptoms. The 14-item HAMA total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity.
Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment

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。

スポンサー

Capital Medical University

捜査官

  • 主任研究者：Zhi Yang, PhD、Beijing Anding Hospital, Capital Medical University

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 (推定)

2026年9月1日

一次修了 (推定)

2027年10月30日

研究の完了 (推定)

2027年10月30日

試験登録日

最初に提出

2026年7月29日

QC基準を満たした最初の提出物

2026年7月29日

最初の投稿 (実際)

2026年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月5日

QC基準を満たした最後の更新が送信されました

2026年8月3日

最終確認日

2026年8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

  • BRWEP2024W072120106

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

Individual participant data will not be shared because the current informed consent and ethics-approved protocol authorize the coded and de-identified clinical and neuroimaging data for use within this study only. Study data will be stored and analyzed on a secure internal institutional server.

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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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