Clinical Implications of FKBP5 in Post-stroke Neural Plasticity and Neuromodulation Effects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment of Upper Extremity, FMA-UE
研究概览
简要总结
With contemporary lifestyle changes and global aging, it is important yet unknown how stress interacts to post-stroke outcomes. This proposal aims to study the link between the stress-responsive FKBP51-related pathways and neural plasticity after stroke, elucidating FKBP5 gene polymorphisms and blood FKBP51 regulation in relation to brain excitability and functions, understanding the effects of transcranial direct current stimulation, and characterizing brain mechanisms for individualized early rehabilitation after stroke.
详细描述
Stress is an underestimated risk factor and also a consequence of cardiovascular diseases and stroke. FK506-binding protein 51 (FKBP51) modulates stress responses by acting as a co-chaperone that negatively regulates glucocorticoid receptor (GR) to cortisol binding and nuclear signaling. In an oxygen-glucose deprivation (OGD) model of acute mouse hippocampal slices, FKBP5 deletion reduced ischemic neuronal hyperexcitation, and cathodal electrical stimulation of OGD-injured wild-type decreased FKBP51 levels. However, clinical implications of FKBP5 polymorphisms and FKBP51 regulation in post-stroke outcomes and neuromodulation-induced plasticity are unknown. We aim to assess the link between FKBP5 polymorphisms and blood FKBP51 regulation after stroke, and their relationship with stroke phenotypes, brain connectivity and functional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral ischemic or hemorrhagic stroke
- •Aged 20-80 years old
排除标准
- •FMA-UE is over 49 points
- •Major psychiatric diseases
- •Major neurologic diseases
- •Global aphasia
研究组 & 干预措施
Active transcranial direct current stimulation (tDCS)
Weak direct currents with 2 mA are delivered 20 minutes per session (including 30s ramp-up and 30s ramp-down) during tailored upper extremity task practice. Total sessions are 20 over 10 days.
干预措施: Bihemispheric tDCS (Device)
Sham tDCS
The device is automatically shut down after 2-minute stimulation. Treatment sessions and frequency are the same as the Experimental arm.
干预措施: Bihemispheric tDCS (Device)
结局指标
主要结局
Fugl-Meyer Assessment of Upper Extremity, FMA-UE
时间窗: Change score from baseline (~10 days poststroke) to 90 days poststroke
Motor recovery of upper extremity poststroke
次要结局
- Fugl-Meyer Assessment of Lower Extremity, FMA-LE(Change score from baseline (~10 days poststroke) to 90 days poststroke)
- Action Research Arm Test, ARAT(Change score from baseline (~10 days poststroke) to 90 days poststroke)
- Perceived Stress Scale-10(Change score from baseline (~10 days poststroke) to 90 days poststroke)
- Protein and gene test(Change score from baseline (~10 days poststroke) to 90 days poststroke)