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Multi-target TMS for Schizophrenia Negative Symptoms

2026年9月6日 更新者：Shanghai Mental Health Center

Development of a Multi-target Transcranial Magnetic Intervention Technique for Negative Symptoms of Schizophrenia

This randomized controlled trial (RCT) is the first to evaluate the efficacy and safety of a multi-target TMS protocol targeting the right orbitofrontal cortex (R-OFC), left dorsolateral prefrontal cortex (L-DLPFC), and left inferior parietal lobule (L-IPL) for negative symptoms of schizophrenia.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Schizophrenia is a chronic and severe mental disorder. Although antipsychotic medications are effective for positive symptoms, they offer limited improvement for negative symptoms and cognitive deficits. Effective treatments for these symptoms are still lacking. To address current clinical bottlenecks, there is an urgent need to develop novel, effective treatment strategies. Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique. The latest evidence-based guidelines indicate that the level of evidence for rTMS in treating schizophrenia remains low (i.e., Level C evidence, possibly effective). However, the critical parameter of target selection has not received sufficient attention. This randomized controlled trial (RCT) is the first to evaluate the efficacy and safety of a multi-target TMS protocol targeting the Right Orbitofrontal Cortex (R-OFC), Left Dorsolateral Prefrontal Cortex (L-DLPFC), and Left Inferior Parietal Lobe (L-IPL) for negative symptoms of schizophrenia. MRI-guided neuronavigation will be used to localize targets in each subject. The intensity of TMS stimulations is set to 80-120% of resting motor threshold (RMT). A total of 50 TMS sessions will be administered. The stimulation sequence will be R-OFC (1 Hz) → L-DLPFC (iTBS) → L-IPL (iTBS). The first target (R-OFC) will receive 720 pulses at 1 Hz, while the second and third targets (L-DLPFC and L-IPL) will each receive 900 pulses of iTBS. Five sessions will be delivered per day for 10 consecutive working days, with a 60-minute interval between sessions. Clinical assessments, cognitive evaluations, and resting-state functional Magnetic Resonance Imaging (MRI) scans will be performed before and after TMS treatment.

研究の種類

介入

入学 (推定)

64

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：Huiru Cui, Ph.D
  • 電話番号：+86 21 34773230
  • メール：cuihuiru@163.com

研究場所

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200030
        • Shanghai Mental Health Center
        • 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

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Outpatients or inpatients at the Department of Psychiatry, Shanghai Mental Health Center;
  2. Meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for first-episode schizophrenia (diagnosed using the Structured Clinical Interview for DSM-5, SCID-5); disease duration less than 5 years at enrollment;
  3. Male or female aged 16-45 years;
  4. Education duration ≥ 9 years;
  5. Stable medication regimen for at least 6 weeks prior to baseline visit and throughout the study period; psychiatric symptoms generally stable within 1 month prior to baseline visit;
  6. Participants and their guardians can understand and sign written informed consent;
  7. Total score on the PANSS Negative Symptom subscale (PANSS-N) > 15, and at least one item score ≥ 3.

Exclusion Criteria:

  1. Current or lifetime psychiatric disorders as determined by SCID-5 assessment;
  2. Severe or unstable physical illnesses, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension, hyperglycemia, malignant tumors, and immunocompromised conditions;
  3. Alcohol abuse within 30 days prior to the study or alcohol/drug dependence within 6 months prior to the study; participation in any clinical trial within 30 days prior to baseline;
  4. Pregnant or breastfeeding women;
  5. Intellectual disability (IQ < 70);
  6. No history of modified electroconvulsive therapy (mECT) within the past 6 months.

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
アクティブコンパレータ：TMS intervention targeting multiple targets
デバイス：repetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.
偽コンパレータ：Control group
Same targets, sham TMS
デバイス：repetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.

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
Change in severity of negative symptoms before and after TMS intervention, i.e., change in Positive and Negative Syndrome Scale - Negative subscale (PANSS-N)
時間枠：Negative symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.

Schizophrenia negative symptoms assessed using Positive and Negative Syndrome Scale - Negative subscale (PANSS-N)

Minimum value: 7 (each of the 7 items scored 1 = absent)

Maximum value: 49 (each of the 7 items scored 7 = extreme)

Higher score indicates: Worse outcome (greater severity of negative symptoms)
Negative symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in cognitive function scores before and after intervention
時間枠：MATRICS Consensus Cognitive Battery (MCCB) will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and 4 weeks ( Day 42) after completion of TMS treatment.
MATRICS Consensus Cognitive Battery (MCCB) total score and subtest scores
MATRICS Consensus Cognitive Battery (MCCB) will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and 4 weeks ( Day 42) after completion of TMS treatment.
Change in positive symptom scores before and after intervention
時間枠：Positive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.

Positive and Negative Syndrome Scale - Positive subscale (PANSS-P)

Minimum value: 7 (each of the 7 items scored 1 = absent)

Maximum value: 49 (each of the 7 items scored 7 = extreme)

Higher score indicates: Worse outcome (greater severity of positive symptoms)
Positive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
Change in general symptom scores before and after intervention
時間枠：General symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
Global Assessment of Functioning (GAF) score. The score ranges from 0 to 100 points. Higher scores indicate better levels of functioning.
General symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
Change in anxiety symptoms before and after intervention
時間枠：Anxiety symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
Anxiety symptoms measured using Hamilton Anxiety Rating Scale (HAMA). Each item scored 0 (not present) to 4 (severe), total score range 0-56. Higher scores indicate more severe symptoms.
Anxiety symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
Depressive symptoms changes
時間枠：Depressive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
Depressive symptoms measured using Hamilton Depression Rating Scale (HAMD). Measure of depression severity - total score ranges from 0 (no depression) to 76 (most severe depression)
Depressive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TMS (Day 14), and at 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TMS treatment.
Safety as measured by number of participants with Adverse Events
時間枠：Record the adverse events reported on that day after completing the day's TMS treatment. This should be done every day during the treatment period (Day 0 - Day 14)
Number of Adverse Events reported during TMS treatment
Record the adverse events reported on that day after completing the day's TMS treatment. This should be done every day during the treatment period (Day 0 - Day 14)
Resting-state functional MRI (rsfMRI) scan
時間枠：Resting-state functional MRI will be measured at baseline (Day-4±2), and immediately after the 50th session of TMS (Day 14).
Functional MRI scan will be conducted before and after treatment to assess treatment-induced changes in brain connectivity
Resting-state functional MRI will be measured at baseline (Day-4±2), and immediately after the 50th session of TMS (Day 14).

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

Shanghai Mental Health Center

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10月1日

一次修了 (推定)

2027年12月30日

研究の完了 (推定)

2028年1月30日

試験登録日

最初に提出

2026年4月9日

QC基準を満たした最初の提出物

2026年4月26日

最初の投稿 (実際)

2026年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月10日

QC基準を満たした最後の更新が送信されました

2026年9月6日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB, SMHC, 2025-97

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?

はい

IPD プランの説明

Other researchers should submit a request to the PI. Data sharing will only occur after the PI's approval.

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