Clinical Implications of FKBP5 in Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Bihemispheric tDCS

• Registration Number: NCT05198037
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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 Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-23
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-01-20
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active transcranial direct current stimulation (tDCS)	Bihemispheric 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.
Sham tDCS	Bihemispheric tDCS	The device is automatically shut down after 2-minute stimulation. Treatment sessions and frequency are the same as the Experimental arm.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment of Upper Extremity, FMA-UE	Change score from baseline (~10 days poststroke) to 90 days poststroke	Motor recovery of upper extremity poststroke

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment of Lower Extremity, FMA-LE	Change score from baseline (~10 days poststroke) to 90 days poststroke	Motor recovery of lower extremity poststroke
Action Research Arm Test, ARAT	Change score from baseline (~10 days poststroke) to 90 days poststroke	Motor function of upper extremity poststroke
Perceived Stress Scale-10	Change score from baseline (~10 days poststroke) to 90 days poststroke	Stress level poststroke
Protein and gene test	Change score from baseline (~10 days poststroke) to 90 days poststroke	Protein expression poststroke and identifying genotypes of participants

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei City, Taiwan