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

NCT ID: NCT06810817

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-28

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tDCS and cognitive behavioural programme with physical training

Group Type EXPERIMENTAL

tDCS & cognitive behavioral programme with home-based physical training

Intervention Type 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 and cognitive behavioural programme with physical training

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Group Type ACTIVE_COMPARATOR

physical training

Intervention Type BEHAVIORAL

Participants will have physical training at home for 8 weeks.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type BEHAVIORAL

physical training

Participants will have physical training at home for 8 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Shamay Ng

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Shamay NG

Role: CONTACT

852-2766-4889

Facility Contacts

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Shamay NG

Role: primary

852-2766-4889

Other Identifiers

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HSEARS20240310002

Identifier Type: -

Identifier Source: org_study_id

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