Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06810817
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

This study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke.

Detailed Description

This study will adopt a randomized controlled trial. Participants will be randomized into one of the 3 groups. One group will receive transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. Another group will receive sham transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. One group will receive home-based physical training only.

Study Timeline

• Study Start: 2024-10-28
• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• diagnosed with stroke at least 6 months ago
• Fatigue Assessment Scale score ≥20
• cognitively intact

Exclusion Criteria

• Unstable medical conditions leading to fatigue
• Under any clinical trials
• with any other neurological diseases
• history of transient ischemic attack
• Contraindications to tDCS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue Assessment Scale	baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Geriatric Depression Scale	baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Reintegration to Normal Living Index	baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Cardio-ankle vascular index	baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
performance fatigue index	baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
psychomotor vigilance task	baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong