NCT06810817

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
6mo left

Started Oct 2024

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Oct 2024Dec 2026

Study Start

First participant enrolled

October 28, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

January 28, 2025

Last Update Submit

February 3, 2025

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Fatigue Assessment Scale

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

Secondary Outcomes (6)

  • Pittsburgh Sleep Quality Index

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

  • Geriatric Depression Scale

    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

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

  • Cardio-ankle vascular index

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

  • performance fatigue index

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

  • +1 more secondary outcomes

Study Arms (3)

tDCS and cognitive behavioural programme with physical training

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

sham tDCS and cognitive behavioural programme with physical training

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

physical training

ACTIVE COMPARATOR
Behavioral: physical training

Interventions

tDCS & cognitive behavioral programme with home-based physical trainingCOMBINATION_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.

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

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.

sham tDCS and cognitive behavioural programme with physical training
physical trainingBEHAVIORAL

Participants will have physical training at home for 8 weeks.

physical training

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with stroke at least 6 months ago
  • Fatigue Assessment Scale score ≥20
  • cognitively intact

You may not qualify if:

  • Unstable medical conditions leading to fatigue
  • Under any clinical trials
  • with any other neurological diseases
  • history of transient ischemic attack
  • Contraindications to tDCS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current StimulationPhysical Conditioning, Human

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Shamay NG

CONTACT

852-2766-4889shamay.ng@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 6, 2025

Study Start

October 28, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)