Clinical Implications of FKBP5 in Stroke

NCT05198037 | Unknown

• 1 other identifier: 2021-02-002C
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Action Research Arm Test, ARAT

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

• Fugl-Meyer Assessment of Lower Extremity, FMA-LE

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

• Perceived Stress Scale-10

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

• Protein and gene test

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

Other Outcomes (1)

• Resting-state structural and functional connectivity by magnetic resonance imaging

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

Study Arms (2)

Active transcranial direct current stimulation (tDCS)

EXPERIMENTAL

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.

Device: Bihemispheric tDCS

Sham tDCS

SHAM COMPARATOR

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

Device: Bihemispheric tDCS

Interventions

Bihemispheric tDCS DEVICE

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.

Active transcranial direct current stimulation (tDCS); Sham tDCS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral ischemic or hemorrhagic stroke
• Aged 20-80 years old

You may not qualify if:

• FMA-UE is over 49 points
• Major psychiatric diseases
• Major neurologic diseases
• Global aphasia

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

I-Hui Lee, MD, PhD

CONTACT

+ 886-2-28712121; ihlee@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 20, 2022
• Study Start: November 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

TW (1)