Clinical trial NCT05198037: Clinical Implications of FKBP5 in Stroke
Official title: Clinical Implications of FKBP5 in Post-stroke Neural Plasticity and Neuromodulation Effects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
FKBP5
Motor
Transcranial direct current stimulation
Plasticity
Stress
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-01-20
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Anticipated 100 participants are assigned to the experimental or sham-controlled groups with an allocation rate of 1:1, for the clinical trial. In addition, another group of patients participates in the observational study (no intervention).
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity, FMA-UE
timeFrame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Secondary outcomes:
measure: Action Research Arm Test, ARAT
timeFrame: Change score from baseline (~10 days poststroke) to 90 days poststroke
measure: Fugl-Meyer Assessment of Lower Extremity, FMA-LE
timeFrame: Change score from baseline (~10 days poststroke) to 90 days poststroke
measure: Perceived Stress Scale-10
timeFrame: Change score from baseline (~10 days poststroke) to 90 days poststroke
measure: Protein and gene test
timeFrame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Other outcomes:
measure: Resting-state structural and functional connectivity by magnetic resonance imaging
timeFrame: Change score from baseline (~10 days poststroke) to 90 days poststroke
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: