Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia

Официальное название

Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie

Обзор

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.

Вмешательства

• Устройство Intermittent theta-burst stimulation
  Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex
• Устройство Sham intermittent theta-burst stimulation
  Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex

Первичные конечные точки

• Change in negative symptoms [Срок оценки: From enrollment to the end of iTBS treatment]

Вторичные конечные точки (12)

• Change in negative symptoms at 4-week follow-up [Срок оценки: From enrollment to follow-up 4 weeks after the end of iTBS treatment]
• Speech-gesture rating task [Срок оценки: From enrollment to the end of iTBS treatment]
• Speech-gesture rating task at 4-week follow-up [Срок оценки: From enrollment to follow-up 4 weeks after the end of iTBS treatment]
• Eye-Tracking Task [Срок оценки: From enrollment to the end of iTBS treatment]
• Eye-Tracking Task at 4-week follow-up [Срок оценки: From enrollment to 4 weeks after the end of iTBS treatment]
• Reading the Mind in the Eyes Test [Срок оценки: From enrollment to 4 weeks after the end of iTBS treatment]
• Reading the Mind in the Eyes Test at 4-week follow-up [Срок оценки: From enrollment to 4 weeks after the end of iTBS treatment]
• N-Back Test [Срок оценки: From enrollment to the end of iTBS treatment]
• N-Back Test at 4-week follow-up [Срок оценки: From enrollment to the end of iTBS treatment]
• FMRI: Resting-state functional connectivity [Срок оценки: From enrollment to the end of iTBS treatment]
• FMRI: Resting-state functional connectivity at 4-week follow-up [Срок оценки: From enrollment to 4 weeks after the end of iTBS treatment]
• FMRI: Task-related functional connectivity [Срок оценки: From enrollment to the end of iTBS treatment]

Критерии участия

Критерии включения

• Diagnosis of schizophrenia (ICD-10: F20.-)
• Age: 18-65 years
• Ability to give informed consent
• Signed informed consent form

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Hannover Medical School — Hanover

Идентификаторы

NCT: NCT06740747 · 11473_BO_S_2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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