Multi-target TMS for Schizophrenia Negative Symptoms
6 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
64
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Huiru Cui, Ph.D
- Número de teléfono: +86 21 34773230
- Correo electrónico: cuihuiru@163.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200030
- Shanghai Mental Health Center
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Contacto:
- Huiru Cui
- Número de teléfono: 86 21 34773230
- Correo electrónico: cuihuiru@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Outpatients or inpatients at the Department of Psychiatry, Shanghai Mental Health Center;
- 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;
- Male or female aged 16-45 years;
- Education duration ≥ 9 years;
- 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;
- Participants and their guardians can understand and sign written informed consent;
- Total score on the PANSS Negative Symptom subscale (PANSS-N) > 15, and at least one item score ≥ 3.
Exclusion Criteria:
- Current or lifetime psychiatric disorders as determined by SCID-5 assessment;
- 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;
- 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;
- Pregnant or breastfeeding women;
- Intellectual disability (IQ < 70);
- No history of modified electroconvulsive therapy (mECT) within the past 6 months.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: TMS intervention targeting multiple targets
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Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.
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Comparador falso: Control group
Same targets, sham TMS
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Repetitive transcranial magnetic stimulation (rTMS) is a recently developed neuromodulation technique.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in severity of negative symptoms before and after TMS intervention, i.e., change in Positive and Negative Syndrome Scale - Negative subscale (PANSS-N)
Periodo de tiempo: 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.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in cognitive function scores before and after intervention
Periodo de tiempo: 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.
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MATRICS Consensus Cognitive Battery (MCCB) total score and subtest scores
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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.
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Change in positive symptom scores before and after intervention
Periodo de tiempo: 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.
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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.
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Change in general symptom scores before and after intervention
Periodo de tiempo: 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.
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Global Assessment of Functioning (GAF) score.
The score ranges from 0 to 100 points.
Higher scores indicate better levels of functioning.
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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.
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Change in anxiety symptoms before and after intervention
Periodo de tiempo: 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.
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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.
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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.
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Depressive symptoms changes
Periodo de tiempo: 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.
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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)
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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.
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Safety as measured by number of participants with Adverse Events
Periodo de tiempo: 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)
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Number of Adverse Events reported during TMS treatment
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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)
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Resting-state functional MRI (rsfMRI) scan
Periodo de tiempo: Resting-state functional MRI will be measured at baseline (Day-4±2), and immediately after the 50th session of TMS (Day 14).
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Functional MRI scan will be conducted before and after treatment to assess treatment-induced changes in brain connectivity
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Resting-state functional MRI will be measured at baseline (Day-4±2), and immediately after the 50th session of TMS (Day 14).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
30 de diciembre de 2027
Finalización del estudio (Estimado)
30 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
9 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de septiembre de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB, SMHC, 2025-97
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Other researchers should submit a request to the PI.
Data sharing will only occur after the PI's approval.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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