Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM) (TMS CBM)
2026年6月4日 更新者：Richard Liu、The University of Hong Kong
The goal of this study is to learn whether combining repetitive transcranial magnetic stimulation (rTMS) with a computerized behavioral intervention (imagery cognitive bias modification, CBM-I) reduces negative interpretation bias and mild-to-moderate depressive symptoms. The study will also examine neural changes in the dorsolateral prefrontal cortex (DLPFC) and whether timing of interventions affects outcomes.
The main questions it aims to answer are:
Does active TMS reduce negative interpretation bias and depressive symptoms more than sham TMS? Is delivering CBM-I concurrently with TMS more effective than delivering it consecutively (separate sessions) at reducing negative bias and depressive symptoms? Do combined rTMS + CBM-I approaches produce greater neural changes and improved cognitive control over self-referential interpretation than controls? Researchers will compare active TMS versus sham TMS, and concurrent versus consecutive delivery of CBM-I, to test effects on negative bias and depressive symptoms.
Participants will:
Receive either active rTMS or sham TMS targeting the DLPFC Complete imagery CBM-I sessions either concurrently with TMS or in separate (consecutive) sessions Undergo assessments of negative interpretation bias, depressive symptoms, and neural measures before and after the intervention
調査の概要
研究の種類
介入
入学 (推定)
180
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
- 名前：Richard Liu Mr. Liu
- 電話番号：+85290971398
- メール：richliu18@connect.hku.hk
研究場所
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Hong Kong Island
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Quarry Bay、Hong Kong Island、香港
- 募集
- InnoCentre of Clinical Neuropsychology, The University of Hong Kong
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コンタクト：
- Richard Mr. Liu
- 電話番号：+85290971398
- メール：richliu18@connect.hku.hk
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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
- 子
- 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:
- Aged 18 years or above
- Right-handed
- Normal or corrected hearing and vision
- Obtained primary education or above
- Able to fluently read and understand Chinese
- Beck's Depression Inventory-II (BDI-II) score ranging from 14-28
Exclusion Criteria:
- History of severe physical disease, brain organic diseases, and neurological disorders (e.g., dementia, brain injury, stroke, epilepsy, Parkinson's disease)
- History of substance use/ dependence/ withdrawal
- Participants with intellectual disability based on IQ scores
- Participants with contraindications for rTMS such as foreign metal bodies, implant devices (cochlear implants) or history (personal or family) of seizure
- Participants who are not suitable to be scanned by magnetic resonance imaging (MRI) machine (e.g., claustrophobic, pregnant, metal in the body, hearing aids)
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：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：CC-R-CBM
Concurrent, Real TMS, CBM
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The rTMS group will receive 10 Hz stimulation to the left DLPFC at an intensity of 120% of the resting motor threshold of the right abductor pollicis brevis (APB) muscle with 4 sec trains and 11 sec intertrain intervals for 3000 pulses.Specifically in our study, we combine both intervention, but applying them concurrently and consecutively between groups.
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation.
Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
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偽コンパレータ：CC-S-CBM
Concurrent, Sham TMS, CBM
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Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation.
Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
The TMS coil will be rotated 90 degrees, and will not be delivering active stimulation to the participant.
The intensity will be set to 30 and the TMS device will be active, generating enough sound effect but no real stimulation for sham control.
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アクティブコンパレータ：CS-R-CBM
Consecutive, Real TMS, CBM
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The rTMS group will receive 10 Hz stimulation to the left DLPFC at an intensity of 120% of the resting motor threshold of the right abductor pollicis brevis (APB) muscle with 4 sec trains and 11 sec intertrain intervals for 3000 pulses.Specifically in our study, we combine both intervention, but applying them concurrently and consecutively between groups.
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation.
Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
|
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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Cognitive Bias
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Self-Referent Encoding Task Tool: PsychoPy Unit:Self-Referential Bias Index measured by positive and negative self-description affirmation
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"From enrollment to the end of treatment at 4 weeks"
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Depressive Symptoms
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Beck's Depressive Inventory-II Tool: Qualtrics Questionnaire Unit:Beck's Depressive Inventory-II Index
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"From enrollment to the end of treatment at 4 weeks"
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Resting State functional MRI
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: resting-state functional MRI Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: functional dicom images
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"From enrollment to the end of treatment at 4 weeks"
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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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Subjective Well Being
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Subjective Well-Being Scale Tool: Qualtrics Questionnaire Unit: Subjective Well-Being Index
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"From enrollment to the end of treatment at 4 weeks"
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Sleep Quality
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Pittsburgh Sleep Quality Index (PSQI) Tool: Qualtrics Questionnaire Unit: Sleep Quality Index
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"From enrollment to the end of treatment at 4 weeks"
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Anxiety Symptoms
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Beck Anxiety Inventory Task Tool: Qualtrics Questionnaire Unit: Anxiety Index
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"From enrollment to the end of treatment at 4 weeks"
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Structural MRI
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: T1 Structural MRI Brain Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: structural dicom images
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"From enrollment to the end of treatment at 4 weeks"
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Rumination Symptoms
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Rumination Response Scale (RRS) Task Tool: Qualtrics Questionnaire Unit: Rumination Index
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"From enrollment to the end of treatment at 4 weeks"
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Anhedonia Symptoms
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Dimensional Anhedonia Rating Scale Tool: Qualtrics Questionnaire Unit: Anhedonia Index
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"From enrollment to the end of treatment at 4 weeks"
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Cognitive Measures-Attention
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Reaction Time
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"From enrollment to the end of treatment at 4 weeks"
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Cognitive Measures-Attention
時間枠："From enrollment to the end of treatment at 4 weeks"
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Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Correct Responses and Error responses will be used to calculate a performance index of sustained attention
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"From enrollment to the end of treatment at 4 weeks"
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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)
2025年2月24日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月9日
QC基準を満たした最後の更新が送信されました
2026年6月4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
その他の研究ID番号
- EA230645
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?
未定
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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
米国で製造され、米国から輸出された製品。
いいえ
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