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Clinical Implications of FKBP5 in Stroke

Primary Purpose

Stroke

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Bihemispheric tDCS

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, FKBP5, Motor, Transcranial direct current stimulation, Plasticity, Stress

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active transcranial direct current stimulation (tDCS)

Sham tDCS

Arm 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.

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

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment of Upper Extremity, FMA-UE

Motor recovery of upper extremity poststroke

Secondary Outcome Measures

Action Research Arm Test, ARAT

Motor function of upper extremity poststroke

Fugl-Meyer Assessment of Lower Extremity, FMA-LE

Motor recovery of lower extremity poststroke

Perceived Stress Scale-10

Stress level poststroke

Protein and gene test

Protein expression poststroke and identifying genotypes of participants

Full Information

NCT ID

NCT05198037

First Posted

November 23, 2021

Last Updated

January 5, 2022

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT05198037

Brief Title

Clinical Implications of FKBP5 in Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, FKBP5, Motor, Transcranial direct current stimulation, Plasticity, Stress

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active transcranial direct current stimulation (tDCS)

Arm Type

Experimental

Arm 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.

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Bihemispheric tDCS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Fugl-Meyer Assessment of Upper Extremity, FMA-UE

Description

Motor recovery of upper extremity poststroke

Time Frame

Change score from baseline (~10 days poststroke) to 90 days poststroke

Secondary Outcome Measure Information:

Title

Action Research Arm Test, ARAT

Description

Motor function of upper extremity poststroke

Time Frame

Change score from baseline (~10 days poststroke) to 90 days poststroke

Title

Fugl-Meyer Assessment of Lower Extremity, FMA-LE

Description

Motor recovery of lower extremity poststroke

Time Frame

Change score from baseline (~10 days poststroke) to 90 days poststroke

Title

Perceived Stress Scale-10

Description

Stress level poststroke

Time Frame

Change score from baseline (~10 days poststroke) to 90 days poststroke

Title

Protein and gene test

Description

Protein expression poststroke and identifying genotypes of participants

Time Frame

Change score from baseline (~10 days poststroke) to 90 days poststroke

Other Pre-specified Outcome Measures:

Title

Resting-state structural and functional connectivity by magnetic resonance imaging

Description

Connectivity-level plasticity post-intervention/poststroke

Time Frame

Change score from baseline (~10 days poststroke) to 90 days poststroke

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

I-Hui Lee, MD, PhD

Phone

+ 886-2-28712121

Ext

8109

ihlee@vghtpe.gov.tw

Facility Information:

Facility Name

Taipei Veterans General Hospital

City

Taipei City

ZIP/Postal Code

112

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

I-Hui Lee, MD, PhD

Phone

886-2-28712121

Ext

8109

ihlee@vghtpe.gov.tw

First Name & Middle Initial & Last Name & Degree

I-Hui Lee, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Clinical Implications of FKBP5 in Stroke

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