Augmentation of Neuronal Network Plasticity in Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Cognition - Spatial Orientation
研究概览
简要总结
Current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. However, therapeutic strategies targeting this specific pathobiology are lacking. Our recent work provides strong evidence that complex video-game training interventions facilitate fronto-hippocampal structural and functional connectivity within 2 months in healthy subjects. The planned project transfers this knowledge into a training study in schizophrenic patients to counteract disease-related disconnectivity. Underlying mechanisms and behavioral effects are extensively parametrized by resting state functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), spectroscopy and clinical short- and long-term outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinically stabilized
- •at least one schizophrenic episode in their lives
- •International Classification of Diseases 10 (ICD-10) F20.x (and F25)
排除标准
- •clinically relevant anemia
- •MRI contraindication
- •earlier electroconvulsive shock treatment
- •significant somatic or neurological disease
- •significant alcohol or substance abuse in the year before
- •more than 1h video games per day more than 6 months before study start
- •simultaneous major psychiatric disease (if symptomatic in the foreground)
研究组 & 干预措施
Kindle Device
No 3D navigation
干预措施: No 3D navigation (Behavioral)
3D Super Mario Game Condition
3D navigation video game intervention
干预措施: 3D navigation video game intervention (Behavioral)
2D Super Mario Game Condition
Video game intervention without 3D navigation
干预措施: video game intervention without 3D navigation (Behavioral)
结局指标
主要结局
Cognition - Spatial Orientation
时间窗: 2 months (= training time and 2 months after training end)
The investigators look for changes in cognition specifically regarding spatial orientation (MATRICS, computer tests measuring spatial orientation with and without external cue) due to training.
Positive & Negative Symptoms in patients
时间窗: 2 months (= training time and 2 months after training end)
The investigators look for changes in positive and negative symptoms (PANSS) due to training.
T1 - MRI
时间窗: 2 months (= training time and 2 months after training end)
The investigators look for structural volume changes in T1 images (MRI) specifically in the hippocampus and prefrontal areas due to training
次要结局
- Diffusion Tensor Imaging (DTI)(2 month (= training time and 2 month after training end))
- Spectroscopy - glutamate(2 month (= training time and 2 month after training end))
- Resting State fMRI(2 months (= training time and 2 months after training end))
- Biomarkers (BDNF & interleukin 1 & 6)(2 month (= training time and 2 month after training end))