Estimulación intermitente Theta-Burst para mejorar los síntomas negativos y la cognición en la esquizofrenia (ITBS-NKS-2024)
Estimulación intermitente Theta-Burst para la reducción de los síntomas negativos y la cognición de la esquizofrenia
The planned randomized, sham-controlled, double-blind, monocentric study aims to evaluate the effectiveness of intermittent Theta-Burst Stimulation (iTBS) on negative symptoms and cognitive deficits in schizophrenia. Both the cerebellar vermis and the left dorsolateral prefrontal cortex will be stimulated successively within the same session.
The goal of this trial is to learn if intermittent theta-burst stimulation (iTBS) of the cerebellum and the left dorsolateral prefrontal cortext (DLPFC) can treat negative symptoms and improve cognition in patients with schizophrenia. The main question it aims to answer is:
Does iTBS of the cerebellum and the left DLPFC improve negative symptoms in patients with schizophrenia? Researchers will compare iTBS to sham stimulation to see if iTBS improves negative symptoms.
Participants will:
- Receive 10 sessions of iTBS over the course of 2 weeks
- Undergo extensive examination before iTBS treatment, immediately after iTBS treatment and 4 weeks after iTBS treatment. The examination includes assessment of negative symptoms; psychometric assessment of cognition, social cognition, depressive symptoms; functional magnetic resonance imaging; assessment of eye movements; blood and saliva sampling; assessment of adverse events and stimulation associated sensations.
The study thus seeks to determine whether iTBS of the fronto-cerebellar network might improve negative symptoms and cognition by altering the network's functional activity. Additionally, it will investigate whether a pro-inflammatory cytokine profile could affect iTBS outcomes and whether inflammatory markers could be affected by iTBS.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rasmus Schülke, MD (Dr. med.)
- Número de teléfono: +49 511 532 2039
- Correo electrónico: schuelke.rasmus@mh-hannover.de
Ubicaciones de estudio
-
-
Lower Saxony
-
Hanover, Lower Saxony, Alemania, 30625
- Reclutamiento
- Hannover Medical School
-
Contacto:
- Rasmus Schülke, MD (Dr. med.)
- Número de teléfono: +49 511 532 2039
- Correo electrónico: schuelke.rasmus@mh-hannover.de
-
Investigador principal:
- Rasmus Schülke, MD (Dr. med.)
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of schizophrenia (ICD-10: F20.-)
- Age: 18-65 years
- Ability to give informed consent
- Signed informed consent form
Exclusion Criteria:
- Any electronic implants
- Non-MRI-compatible metal implants (e.g., pacemaker, cochlear implant, insulin pump, metal fragment injuries, work in the metal-processing industry)
- Non-TMS-compatible metal implants (compatible items include: earrings, piercings, dental fillings, crowns, implants)
- Claustrophobia
- Epilepsy
- History of traumatic brain injury within the last 3 months
- History of stroke
- Active central nervous system (CNS) infection
- History of CNS infection within the last 3 months
- Pregnancy
- Current drug, medication, or alcohol abuse
- Simultaneous participation in another clinical trial
- Planned changes in psychopharmacological medication within the next 2 weeks
- Severe physical illnesses that could endanger the patient, affect the examinations or make the MRI scanning cause additional burden
Plan de estudios
¿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 |
|---|---|
|
Experimental: iTBS
Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex |
Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex |
|
Comparador falso: Sham iTBS
Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex |
Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in negative symptoms
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Change in negative symptoms, measured with the Clinical Assessment Interview for Negative Symptoms (CAINS). Higher CAINS scores correspond to more negative symptoms. The minimum total score is 0 points, the maximum total score is 52 points. |
From enrollment to the end of iTBS treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in negative symptoms at 4-week follow-up
Periodo de tiempo: From enrollment to follow-up 4 weeks after the end of iTBS treatment
|
Change in negative symptoms, measured with the Clinical Assessment Interview for Negative Symptoms (CAINS). Higher CAINS scores correspond to more negative symptoms. The minimum total score is 0 points, the maximum total score is 52 points. |
From enrollment to follow-up 4 weeks after the end of iTBS treatment
|
|
Speech-gesture rating task
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Accuracy and speed of evaluations in the Speech-Gesture Rating Task. |
From enrollment to the end of iTBS treatment
|
|
Speech-gesture rating task at 4-week follow-up
Periodo de tiempo: From enrollment to follow-up 4 weeks after the end of iTBS treatment
|
Accuracy and speed of evaluations in the Speech-Gesture Rating Task at 4-week follow-up. |
From enrollment to follow-up 4 weeks after the end of iTBS treatment
|
|
Eye-Tracking Task
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Changes in eye movements in the Eye-Tracking Task. |
From enrollment to the end of iTBS treatment
|
|
Eye-Tracking Task at 4-week follow-up
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS treatment
|
Changes in eye movements in the Eye-Tracking Task at 4-week follow-up. |
From enrollment to 4 weeks after the end of iTBS treatment
|
|
Reading the Mind in the Eyes Test
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS treatment
|
Reading the Mind in the Eyes Test. |
From enrollment to 4 weeks after the end of iTBS treatment
|
|
Reading the Mind in the Eyes Test at 4-week follow-up
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS treatment
|
Reading the Mind in the Eyes Test at 4-week follow-up. |
From enrollment to 4 weeks after the end of iTBS treatment
|
|
N-Back Test
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Working memory performance in the N-Back Test (sensitivity index). |
From enrollment to the end of iTBS treatment
|
|
N-Back Test at 4-week follow-up
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Working memory performance in the N-Back Test (sensitivity index) 4 weeks after the end of iTBS treatment. |
From enrollment to the end of iTBS treatment
|
|
FMRI: Resting-state functional connectivity
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Changes in resting-state functional connectivity in functional magnetic resonance imaging. Focus on connectivity between cerebellar vermis and DLPFC. |
From enrollment to the end of iTBS treatment
|
|
FMRI: Resting-state functional connectivity at 4-week follow-up
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS treatment
|
Changes in resting-state functional connectivity in functional magnetic resonance imaging. Focus on connectivity between cerebellar vermis and DLPFC. |
From enrollment to 4 weeks after the end of iTBS treatment
|
|
FMRI: Task-related functional connectivity
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Changes in task-related functional connectivity in functional magnetic resonance imaging, for the N-Back-task and the speech-gesture rating task. |
From enrollment to the end of iTBS treatment
|
|
FMRI: Task-related functional connectivity at 4-week follow-up
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS treatment
|
Changes in task-related functional connectivity in functional magnetic resonance imaging, for the N-Back-task and the speech-gesture rating task. |
From enrollment to 4 weeks after the end of iTBS treatment
|
|
Inflammatory cytokines
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Concentrations of inflammatory cytokines (especially IL-6 and TNF-α) in serum and saliva. |
From enrollment to the end of iTBS treatment
|
|
Inflammatory cytokines at 4-week follow-up
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS treatment
|
Concentrations of inflammatory cytokines (especially IL-6 and TNF-α) in serum and saliva. |
From enrollment to 4 weeks after the end of iTBS treatment
|
|
Stimulation-associated perceptions
Periodo de tiempo: From the beginning of each iTBS stimulation to after the end of each iTBS stimulation
|
Stimulation-associated perceptions, measured using the TMS Adverse Events and Associated Sensations Questionnaire (TMSensQ, Section IV), after each iTBS session. |
From the beginning of each iTBS stimulation to after the end of each iTBS stimulation
|
|
Therapy dropout rate
Periodo de tiempo: From the beginning of iTBS treatment to the end of iTBS treatment
|
Therapy dropout rate (i.e. study termination). |
From the beginning of iTBS treatment to the end of iTBS treatment
|
|
Serious Adverse Events (SAEs)
Periodo de tiempo: From the beginning of iTBS treatment to the end of iTBS treatment
|
Serious Adverse Events (SAEs), measured using TMSensQ (Section V). |
From the beginning of iTBS treatment to the end of iTBS treatment
|
|
Self-reported depression: BDI-II
Periodo de tiempo: From enrollment to the end of iTBS-treatment
|
Self-reported depression, measured using the Beck Depression Inventory-II (BDI-II). Higher scores correspond to more depressive symptoms. The minimum total score is 0 points, the maximum total score is 63 points. |
From enrollment to the end of iTBS-treatment
|
|
Self-reported depression at 4-week follow-up: BDI-II
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS-treatment
|
Self-reported depression, measured using the Beck Depression Inventory-II (BDI-II). Higher scores correspond to more depressive symptoms. The minimum total score is 0 points, the maximum total score is 63 points. |
From enrollment to 4 weeks after the end of iTBS-treatment
|
|
Self-rated gesture perception and production: BAG
Periodo de tiempo: From enrollment to the end of iTBS-treatment
|
Change in self-rated gesture perception and production, measured using the Brief Assessment of Gestures (BAG) questionnaire. Higher BAG scores correspond to greater engagement with or reliance on gestures in communication and indicate stronger tendencies to produce or perceive gestures effectively in different contexts. The minimum total score is 12 points, the maximum total score is 60 points. |
From enrollment to the end of iTBS-treatment
|
|
Self-rated gesture perception and production at 4-week follow-up: BAG
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS-treatment
|
Change in self-rated gesture perception and production, measured using the Brief Assessment of Gestures (BAG) questionnaire. Higher BAG scores correspond to greater engagement with or reliance on gestures in communication and indicate stronger tendencies to produce or perceive gestures effectively in different contexts. The minimum total score is 12 points, the maximum total score is 60 points. |
From enrollment to 4 weeks after the end of iTBS-treatment
|
|
Epigenetic changes of neurotrophic and immunological factors
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Exploratory molecular biological investigations focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, t-PA, S100A10) factors. |
From enrollment to the end of iTBS treatment
|
|
Epigenetic changes of neurotrophic and immunological factors at 4-week follow-up
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS treatment
|
Exploratory molecular biological investigations focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, t-PA, S100A10) factors. |
From enrollment to 4 weeks after the end of iTBS treatment
|
|
Concentrations of markers of neuronal damage
Periodo de tiempo: From enrollment to the end of iTBS treatment
|
Concentrations of markers of neuronal damage (e.g., NSE, S100-β) in serum. |
From enrollment to the end of iTBS treatment
|
|
Concentrations of markers of neuronal damage at 4-week follow-up
Periodo de tiempo: From enrollment to 4 weeks after the end of iTBS treatment
|
Concentrations of markers of neuronal damage (e.g., NSE, S100-β) in serum. |
From enrollment to 4 weeks after the end of iTBS treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rasmus Schülke, MD (Dr. med.), Hannover Medical School
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11473_BO_S_2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Whether IPD may be shared has not yet been decided. IPD might not be shared due to data protection laws.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .