Personalized and Accelerated Transcranial Magnetic Stimulation for Treatment-resistant Anxiety Related Disorders (I2Start)
2026年8月31日 更新者：National University Hospital, Singapore
This proposal seeks to carry out an open-label single arm study to examine the neurobehavioral changes induced by personalized, causal network mapping guided accelerated intermittent theta burst stimulation (aiTBS) in patients with treatment-resistant anxiety-related disorders.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
24
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：Phern Chern Tor, MBBS
- 電話番号：+65 6908 2222
- メール：cip@nuhs.edu.sg
研究場所
-
-
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Singapore、シンガポール
- National University Hospital, Singapore
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コンタクト：
- Phern Chern Tor, MBBS
- 電話番号：+65 6908 2222
- メール：cip@nuhs.edu.sg
-
-
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:
- Male/ female aged ≥ 21 years and ≤ 70 years
- Diagnosis of an anxiety-related disorder as validated by the MINI (Specifically, the types of anxiety-related disorders are: generalized anxiety disorder; panic disorderl social anxiety disorder; obsessive compulsive disorder; post-traumatic stress disorder; agoraphobia; anxiety disorder due to another medical condition; other specified anxiety disorders; and unspecified anxiety disorder.)
- Non-response to adequate trial (4 weeks) of at least two anxiety medication as verified by the study clinician, or psychotherapy for anxiety
- BAI score of 16 or above
- Able to give informed consent
- Able to understand English
Exclusion Criteria:
- DSM-5 psychotic disorder
- Significant personality disorder which may hinder the progress of this study
- Drug or alcohol abuse or dependency (preceding 3 months)
- Rapid clinical response required, e.g., high suicide risk
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
- Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pumps or any other electronic implants/ devices
- Tattoos containing derromagnetic ink or permanent piercings
- Currently wearing dental braces
- Pregnancy
- Unsuitable for MRI or TMS for any other reasons
- With recent TMS or ECT treatment within the past 3 months
- Currently on multiple stimulant medications (2 or more)
- Participant does not have the capacity to provide consent
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：Individualized neuronavigated intermittent theta burst stimulation (MagPro X100) system for anxiety
Participants will receive an accelerated intermittent theta burst stimulation (iTBS) treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil.
The treatment course is comprised of 6 treatment sessions daily for 5 consecutive workdays for a total of 30 sessions.
Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions).
All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines.
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Magpro X100, Axilium Cobot, Localite Camera
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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 |
|---|---|---|
|
Beck Anxiety Inventory (BAI)
時間枠：Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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The primary outcome will be the response rate as defined as ≥50% reduction from baseline BAI scores pre- and post-iTBS treatment.
BAI is an ordinal self-report scale measuring physical and cognitive anxiety symptoms ranging from 0-63.
Higher scores mean worse outcome.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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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Beck Depression Inventory (BDI)
時間枠：Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Change in BDI scores pre- and post-iTBS treatment.
BDI is an ordinal self-report scale measuring depressive symptoms ranging from 0-63.
Higher scores mean worse outcome.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
|
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Penn State Worry Questionnaire (PSWQ)
時間枠：Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Change in PSWQ scores pre- and post-iTBS treatment.
PSWQ is an ordinal self-report scale measuring pathological worry ranging from 16-80.
Scores depend on whether the item is worded positively or negatively.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ)
時間枠：Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Change in Mini-MASQ scores pre- and post-iTBS treatment.
The Mini-MASQ is an orginal self-report scale measuring symptoms of anxiety and depression.
Scores depend on whether the item is worded positively or negatively.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Hamilton Anxiety Rating Scale (HAM-A)
時間枠：Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Change in HAM-A scores pre- and post-iTBS treatment.
HAM-A is an ordinal clinician-rated scale measuring severity of psychic and somatic anxiety, ranging from 0-56.
Higher scores mean a worse outcome.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Inventory of Depression and Anxiety Symptoms-II (IDAS-II)
時間枠：Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Change in IDAS-II scores pre- and post-iTBS treatment.
IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symptoms ranging from 99-495.
Higher scores mean worse outcome.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Sheehan Disability Scale (SDS)
時間枠：Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Change in SDS scores pre- and post-iTBS treatment.
SDS is an ordinal self-report scale measuring how symptoms affect functional imapirment across work/ school, social life, and family/ home responsibilities, ranging from 0-10 for each domain.
Higher scores mean a worse outcome.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation of changes in functional connectivity with changes in BAI scores
時間枠：Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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The investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.
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Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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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 (推定)
2026年9月1日
一次修了 (推定)
2029年12月1日
研究の完了 (推定)
2029年12月1日
試験登録日
最初に提出
2026年8月31日
QC基準を満たした最初の提出物
2026年8月31日
最初の投稿 (実際)
2026年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3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31日
最終確認日
2026年8月1日
詳しくは
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