Clinical Implications of FKBP5 in Post-stroke Neural Plasticity and Neuromodulation Effects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Fugl-Meyer Assessment of Upper Extremity, FMA-UE
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Unilateral ischemic or hemorrhagic stroke
- •Aged 20-80 years old
Exclusion Criteria
- •FMA-UE is over 49 points
- •Major psychiatric diseases
- •Major neurologic diseases
- •Global aphasia
Outcomes
Primary Outcomes
Fugl-Meyer Assessment of Upper Extremity, FMA-UE
Time Frame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Motor recovery of upper extremity poststroke
Secondary Outcomes
- 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)