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临床试验/NCT05198037
NCT05198037招募中不适用

Clinical Implications of FKBP5 in Post-stroke Neural Plasticity and Neuromodulation Effects

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
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

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

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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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