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

February 3, 2025 updated by: Shamay Ng, The Hong Kong Polytechnic University

The Effects of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS and cognitive behavioural programme with physical training
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.
Active Comparator: sham tDCS and cognitive behavioural programme with physical training
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.
Active Comparator: physical training
Behavioral: physical training
Participants will have physical training at home for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20240310002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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