间歇性 Theta 爆发刺激可改善精神分裂症的负面症状和认知能力 (ITBS-NKS-2024)
精神分裂症消极症状和认知的间歇性θ爆发刺激
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.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Rasmus Schülke, MD (Dr. med.)
- 电话号码：+49 511 532 2039
- 邮箱：schuelke.rasmus@mh-hannover.de
学习地点
-
-
Lower Saxony
-
Hanover、Lower Saxony、德国、30625
- 招聘中
- Hannover Medical School
-
接触：
- Rasmus Schülke, MD (Dr. med.)
- 电话号码：+49 511 532 2039
- 邮箱：schuelke.rasmus@mh-hannover.de
-
首席研究员：
- Rasmus Schülke, MD (Dr. med.)
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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 |
|
假比较器：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 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in negative symptoms
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in negative symptoms at 4-week follow-up
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：Rasmus Schülke, MD (Dr. med.)、Hannover Medical School
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Whether IPD may be shared has not yet been decided. IPD might not be shared due to data protection laws.
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