Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in negative symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia (ICD-10: F20.-)
- •Age: 18-65 years
- •Ability to give informed consent
- •Signed informed consent form
排除标准
- •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
- •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
研究组 & 干预措施
iTBS
Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
干预措施: Intermittent theta-burst stimulation (Device)
Sham iTBS
Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex
干预措施: Sham intermittent theta-burst stimulation (Device)
结局指标
主要结局
Change in negative symptoms
时间窗: 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.
次要结局
- Eye-Tracking Task(From enrollment to the end of iTBS treatment)
- Eye-Tracking Task at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- Therapy dropout rate(From the beginning of iTBS treatment to the end of iTBS treatment)
- Serious Adverse Events (SAEs)(From the beginning of iTBS treatment to the end of iTBS treatment)
- Self-reported depression: BDI-II(From enrollment to the end of iTBS-treatment)
- Inflammatory cytokines(From enrollment to the end of iTBS treatment)
- Inflammatory cytokines at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- Self-reported depression at 4-week follow-up: BDI-II(From enrollment to 4 weeks after the end of iTBS-treatment)
- Change in negative symptoms at 4-week follow-up(From enrollment to follow-up 4 weeks after the end of iTBS treatment)
- Speech-gesture rating task(From enrollment to the end of iTBS treatment)
- Speech-gesture rating task at 4-week follow-up(From enrollment to follow-up 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(From enrollment to 4 weeks after the end of iTBS treatment)
- N-Back Test(From enrollment to the end of iTBS treatment)
- N-Back Test at 4-week follow-up(From enrollment to the end of iTBS treatment)
- FMRI: Resting-state functional connectivity(From enrollment to the end of iTBS treatment)
- FMRI: Resting-state functional connectivity at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- FMRI: Task-related functional connectivity(From enrollment to the end of iTBS treatment)
- FMRI: Task-related functional connectivity at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- Stimulation-associated perceptions(From the beginning of each iTBS stimulation to after the end of each iTBS stimulation)
- Self-rated gesture perception and production: BAG(From enrollment to the end of iTBS-treatment)
- Self-rated gesture perception and production at 4-week follow-up: BAG(From enrollment to 4 weeks after the end of iTBS-treatment)
- Epigenetic changes of neurotrophic and immunological factors(From enrollment to the end of iTBS treatment)
- Epigenetic changes of neurotrophic and immunological factors at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
- Concentrations of markers of neuronal damage(From enrollment to the end of iTBS treatment)
- Concentrations of markers of neuronal damage at 4-week follow-up(From enrollment to 4 weeks after the end of iTBS treatment)
研究者
Schülke, Rasmus Dr.
Principal Investigator
Hannover Medical School