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Multi-target TMS for Schizophrenia Negative Symptoms

26. april 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200030
        • Rekruttering
        • Shanghai Mental Health Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: TBS intervention targeting multiple targets (L-DLPFC, L-IPL, R-OFC)
Enhed: repetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.
Sham-komparator: Control group
Same targets, same TBS parameters, coil rotated 180°
Enhed: repetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in severity of negative symptoms before and after TBS intervention, i.e., change in Positive and Negative Syndrome Scale - Negative subscale (PANSS-N)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in cognitive function scores before and after intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Mental Health Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

30. december 2027

Studieafslutning (Anslået)

30. januar 2028

Datoer for studieregistrering

Først indsendt

9. april 2026

Først indsendt, der opfyldte QC-kriterier

26. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB, SMHC, 2025-97

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med SKIZOFRENI 1 (lidelse)

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