Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Multi-target TMS for Schizophrenia Negative Symptoms

26. April 2026 aktualisiert von: 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 left dorsolateral prefrontal cortex (L-DLPFC), left inferior parietal lobule (L-IPL), and right orbitofrontal cortex (R-OFC) for negative symptoms of schizophrenia.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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 Left Dorsolateral Prefrontal Cortex (L-DLPFC), Left Inferior Parietal Lobe (L-IPL), and Right Orbitofrontal Cortex (R-OFC) for negative symptoms of schizophrenia. MRI-guided neuronavigation will be used to localize targets in each subject. Stimulation will be delivered at 100% of the resting motor threshold (RMT), with a total of 50 Theta Burst Stimulation (TBS) sessions, which include intermittent TBS (iTBS) and continuous TBS (cTBS). In the order of L-DLPFC (iTBS)→ L-IPL (iTBS) → R-OFC (cTBS), each target receives 600 pulses, for a total of 1800 pulses across three targets. Five sessions will be administered 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 TBS treatment.

Studientyp

Interventionell

Einschreibung (Geschätzt)

64

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Rekrutierung
        • Shanghai Mental Health Center
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: TBS intervention targeting multiple targets (L-DLPFC, L-IPL, R-OFC)
Gerät: repetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.
Schein-Komparator: Control group
Same targets, same TBS parameters, coil rotated 180°
Gerät: repetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in severity of negative symptoms before and after TBS intervention, i.e., change in Positive and Negative Syndrome Scale - Negative subscale (PANSS-N)
Zeitfenster: Negative symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS 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 TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in cognitive function scores before and after intervention
Zeitfenster: MATRICS Consensus Cognitive Battery (MCCB) will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and 4 weeks ( Day 42) after completion of TBS 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 TBS (Day 14), and 4 weeks ( Day 42) after completion of TBS treatment.
Change in positive symptom scores before and after intervention
Zeitfenster: Positive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS 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 TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.
Change in general symptom scores before and after intervention
Zeitfenster: General symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS 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 TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.
Change in anxiety symptoms before and after intervention
Zeitfenster: Anxiety symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS 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 TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.
Depressive symptoms changes
Zeitfenster: Depressive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.
Depressive symptoms measured using Hamilton Depression Rating Scale (HAMD). Measure of depression severity - total score ranges from 0 (no depression) to 60 (most severe depression)
Depressive symptoms will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and at 1 week (Day 21), 2 weeks (Day 28), and 4 weeks ( Day 42) after completion of TBS treatment.
Safety as measured by number of participants with Adverse Events
Zeitfenster: Record the adverse events reported on that day after completing the day's TBS treatment. This should be done every day during the treatment period (Day 0 - Day 14)
Number of Adverse Events reported during TBS treatment
Record the adverse events reported on that day after completing the day's TBS treatment. This should be done every day during the treatment period (Day 0 - Day 14)
Resting-state functional MRI (rsfMRI) scan
Zeitfenster: Resting-state functional MRI will be measured at baseline (Day-4±2), immediately after the 50th session of TBS (Day 14), and 4 weeks ( Day 42) after completion of TBS treatment.
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), immediately after the 50th session of TBS (Day 14), and 4 weeks ( Day 42) after completion of TBS treatment.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shanghai Mental Health Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

30. Dezember 2027

Studienabschluss (Geschätzt)

30. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

9. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. April 2026

Zuerst gepostet (Tatsächlich)

30. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. April 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB, SMHC, 2025-97

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur SCHIZOPHRENIE 1 (Störung)

Klinische Studien zur repetitive transcranial magnetic stimulation (rTMS)

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Poland

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren