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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: sham tDCS & cognitive behavioral programme with home-based physical training; Combination Product: tDCS & cognitive behavioral programme with home-based physical training; Behavioral: physical training

Study type: Interventional

Funder types: Other

Identifiers

NCT06810817

HSEARS20240310002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

tDCS and cognitive behavioural programme with physical training

Experimental group

Treatment:

Combination Product: tDCS & cognitive behavioral programme with home-based physical training

sham tDCS and cognitive behavioural programme with physical training

Active Comparator group

Treatment:

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

physical training

Active Comparator group

Treatment:

Behavioral: physical training