Clinical Implications of FKBP5 in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198037
• Other study ID #: 2021-02-002C
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 2025

Study information

• Verified date: January 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: I-Hui Lee, MD, PhD
• Phone: + 886-2-28712121
• Email: ihlee[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Bihemispheric tDCS
The anode and cathode are placed over the ipsilesional and contralesional primary motor cortex (C3 or C4 based on 10-20 system), respectively. The size of the electrode is 5x5 cm.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting-state structural and functional connectivity by magnetic resonance imaging	Connectivity-level plasticity post-intervention/poststroke	Change score from baseline (~10 days poststroke) to 90 days poststroke
Primary	Fugl-Meyer Assessment of Upper Extremity, FMA-UE	Motor recovery of upper extremity poststroke	Change score from baseline (~10 days poststroke) to 90 days poststroke
Secondary	Action Research Arm Test, ARAT	Motor function of upper extremity poststroke	Change score from baseline (~10 days poststroke) to 90 days poststroke
Secondary	Fugl-Meyer Assessment of Lower Extremity, FMA-LE	Motor recovery of lower extremity poststroke	Change score from baseline (~10 days poststroke) to 90 days poststroke
Secondary	Perceived Stress Scale-10	Stress level poststroke	Change score from baseline (~10 days poststroke) to 90 days poststroke
Secondary	Protein and gene test	Protein expression poststroke and identifying genotypes of participants	Change score from baseline (~10 days poststroke) to 90 days poststroke