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NCT Number: NCT06810817

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

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.

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS & cognitive behavioral programme with home-based physical training

Combination Product

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.

sham tDCS & cognitive behavioral programme with home-based physical training

Behavioral

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.

physical training

Behavioral

Participants will have physical training at home for 8 weeks.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shamay NG

CONTACT

[email protected]

852-2766-4889

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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