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Recruiting NCT06810817

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

No phase Interventional Stroke

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tDCS & cognitive behavioral programme with home-based physical training, sham tDCS & cognitive behavioral programme with home-based physical training, physical training.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Combination product tDCS & cognitive behavioral programme with home-based physical training
    Participants will receive 16 sessions of tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks.
  • Behavioral sham tDCS & cognitive behavioral programme with home-based physical training
    Participants will receive 16 sessions of sham-tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks.
  • Behavioral physical training
    Participants will have physical training at home for 8 weeks.

Primary outcome measures

  • Fatigue Assessment Scale [Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
Secondary outcome measures (6)
  • Pittsburgh Sleep Quality Index [Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
  • Geriatric Depression Scale [Time frame: 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 [Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
  • Cardio-ankle vascular index [Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
  • performance fatigue index [Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
  • psychomotor vigilance task [Time frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT06810817 · HSEARS20240310002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗