Clinical Implications of FKBP5 in Stroke

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Stroke

Treatments: Device: Bihemispheric tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05198037

2021-02-002C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Active transcranial direct current stimulation (tDCS)

Experimental group

Description:

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.

Treatment:

Device: Bihemispheric tDCS

Sham tDCS

Sham Comparator group

Description:

The device is automatically shut down after 2-minute stimulation. Treatment sessions and frequency are the same as the Experimental arm.

Treatment:

Device: Bihemispheric tDCS